Kits and methods for semen collection and filtration

Abstract

Kits and methods for semen collection and filtration are provided. The kits and methods provide for simple and reliable collection of semen samples away from a clinical setting. The kits and methods also provide for more rapid processing of semen samples, selecting motile sperm through passive filtration approaches, which can be beneficial even when used in a clinical setting. In a broad sense, the kits include a semen collection device such as a condom, a base having a reservoir, and a filtration cap allowing for passive filtration of motile sperm. Methods of using the kits are also provided.

Description

KITS AND METHODS FOR SEMEN COLLECTION AND FILTRATIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to, and the benefit of, co-pending U.S. provisional application entitled “SEMEN COLLECTION KIT AND METHOD” having serial no. 63 / 615,343 filed December 28, 2023, the contents of which are incorporated by reference herein.TECHNICAL FIELD

[0002] The present disclosure generally relates to devices and methods of fertility treatment, and in particular to kits and methods for semen collection.BACKGROUND

[0003] Assisted reproductive technologies (ART) have become a vital solution for many individuals and couples facing infertility, with millions of ART procedures performed annually worldwide, including in vitro fertilization (IVF) and intrauterine insemination (IUI). However, despite significant advancements, the failure rates of ART remain notably high, with success rates for IVF typically ranging between 30% and 40% per cycle, depending on factors like age, health, and underlying fertility issues. These challenges are not just statistical — they carry profound personal impacts, as individuals and couples often experience emotional, psychological, and financial stress after multiple failed attempts. The uncertainty and frustration of undergoing ART procedures, which may involve invasive treatments, hormone therapies, and significant financial costs, can deeply affect relationships, mental health, and overall well-being, highlighting the emotional toll that fertility struggles can take on individuals and families.

[0004] Human semen collection is an important process used in ART. Sperm banks also collect semen for storage, often for future use in fertility treatments or for research purposes. In the United States, over 1 .5 million sperm donor inseminations occur annually, and sperm banks store thousands of semen samples each year. These collections are critical for helping those who require donor sperm or the preservation of sperm for future fertility. Additionally, semen collection is essential in research, particularly in the study of sperm quality, genetics, and the impact of environmental factors on male fertility.

[0005] There remains a need for improved kits and methods for collecting and processing semen samples.SUMMARY OF THE DISCLOSURE

[0006] In various aspects, the present disclosure provides kits and methods for semen collection and filtration. The kits and methods described in the present disclosure overcome many of the deficiencies with prior semen collection and filtration methods, for example the provided semen collection kits and methods can enable simpler at-home collection of semen samples, reduced patient anxiety, improved convenience, higher levels of patient compliance, improved sperm quality, and / or can accommodate pateints with certain religious prohibitions on the use of contraceptives. The kits and methods can also provide for rapid processing of the semen sample to select for higher motility sperm from the sample.

[0007] In various aspects, the disclosure provides a kit for semen collection and filtration. The kit can include a semen collection device, a base, a first cap, a second cap, a means of generating heat, one or more fluid collection or delivery devices, and at least one means for delivering a volume of a sperm wash media. The base has a reservoir for receiving a volume of sample and having an upper opening. The first cap can be configured to attach to the upper opening of the base to form a first container. The second cap can be configured to attach to the upper opening of the base to form a second container. The second cap can include a lower surface having a filter, the filter positioned within the lower surface to contact a sample in the second container when in use. The second cap can further have an enclosed void space in contact with the filter on a side opposite the reservoir. The second cap can futher have one or more ports for inserting a liquid into the void space and / or extracting a liquid sample from the void space while the second cap is attached to the upper opening of the base.

[0008] In some aspects, the the semen collection device is a condom having one or more perforations. This is particularly useful for use by subjects who may have religious or moral objections to contraception. In some aspects, the first cap contains the means of generating heat. In some aspects, the sperm wash media is a preloaded syringe of HEPES opr other buffering media.

[0009] In other aspects, the disclosure provides methods of semen collection and filtration. The methods can include collecting a sample containing semen using a semen collection device and then transferring the sample to a base having a reservoir for receiving the sample and having an upper opening. Attaching a first cap to the upper opening of the base can form a first container. Proximal to attaching the first step, the method can include activating a means of generating heat to maintain the sample within a target temperature range for a period of time, wherein the activating can be manual or automatic. The methods can further include adjusting the volume of the sample in the reservoir to the desired volume and removing the first cap, wherein removing the first cap is performed proximal to the adjusting step. The method can further include attaching the second cap to the upper opening of the base to form the second container containing the desired volume of the sample and thenintroducing a volume of sperm wash media through a port in the second cap. The method can incude delivering the second container to a reproductive health provider and / or waiting a predetermined amount of time to allow the motile sperm to migrate into the void space and then extracting the motile sperm through a port in the second cap.

[0010] In further aspects, the disclosure provides methods of fertility treatment including providing a subject with a kit described herein and receiving a sample comprising motile sperm from the subject. The sample comprising the motile sperm can be received in a second container formed of (i) a base having a reservoir and having an upper opening and (ii) a second cap configured to attach to the upper opening of the base to form the second container.

[0011] Other systems, methods, features, and advantages of semen collection and filtration kits and methods will be or become apparent to one with skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, features, and advantages be included within this description, be within the scope of the present disclosure, and be protected by the accompanying claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Further aspects of the present disclosure will be readily appreciated upon review of the detailed description, described below, when taken in conjunction with the accompanying drawings. The components in the drawings are are simplified for illustrative purposes and not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the several views.

[0013] FIG. 1 is a front perspective view of a perforated condom semen collection device and a base according to an exemplary aspect of the disclosure.

[0014] FIG. 2 is a front view of a a base containing a semen sample and a first cap being attached to the base according to an exemplary aspect of the disclosure.

[0015] FIG. 3 is a front view of a a base containing a semen sample and a first cap being removed from the base according to an exemplary aspect of the disclosure.

[0016] FIG. 4 is a front view of a base with a line of demarcation indicating a desired volume of sample according to an exemplary aspect of the disclosure.

[0017] FIG. 5 is a front view of a base containing a desired volume of sample and a second cap attached to the base to form a second container according to an exemplary aspect of the disclosure.

[0018] FIG. 6 is a front view of a volume of a sperm wash media being introduced through a port in the second cap of the second container depicted in FIG. 5.

[0019] FIG. 7 is a front view of a motility-selected semen sample being collected through a port in the second cap of the second container depicted in FIG. 5.DETAILED DESCRIPTION

[0020] A major issue with current semen collection methods is the dehumanizing aspect of the process. The need for donors to enter medical facilities, sometimes under strict conditions, can make the experience feel impersonal and uncomfortable. The most common method is masturbation into a sterile container, typically performed in a private room within a medical facility. This process, while effective, often introduces issues related to stress, anxiety, and discomfort for the donor. Studies have shown that stress can negatively impact sperm quality, with elevated cortisol levels potentially reducing sperm motility and count. According to a study published in Human Reproduction, sperm quality improves when men are allowed to produce a sample in a relaxed, comfortable environment.1

[0021] The use of sterile rooms, medical staff, and strict protocols may make donors feel like their role is reduced to a mere biological function, stripping away any personal connection to the act. This can lead to feelings of alienation or discomfort for donors, which, in turn, may negatively impact sperm quality. Furthermore, the reliance on clinical settings for collection can limit the number of potential donors, as some men may be unwilling or unable to participate due to the anxiety and stress of the environment.

[0022] For these reasons, there is growing interest in allowing semen collection to be done at home, as it can reduce the psychological stress often associated with performing the task in a medical facility. In fact, one study found that when donors were allowed to provide samples in a familiar, private setting, sperm motility and concentration were significantly higher compared to samples collected in clinical settings.1 However, the methods used for at-home semen collection can present significant technical challenges and most at-home kits are very limited in their utility. Many of the at- home kits are limited to simple measures of sperm motility and are not intended for collection of semen to be used in assisted reproductive procedures such as in vitro fertilization (IVF) or artificial insemination (Al).

[0023] At-home collection for assisted reproductive procedures is often done in a similar manner as is done in the clinic, with semen sample collection being done via masturbation into a sterile cup that must then be transported to the medical facility for subsequent processing. Semen samples typically must be processed using procedures such as sperm washing, sperm concentration using methods such as centrifugation or gradient separation, and sperm selection for sperm having the highestmotility as motility has been shown to lead to higher success rates in assisted reproductive procedures. These processing procedures introduce additional delay if they cannot begin until the sample arrives at the medical facility, but these techniques could be complicated for at-home users. At-home collection devices or kits that allow the processing to begin prior to the sample arriving at the medical facility will provide significant advantages.

[0024] In addition to the psychological and emotional aspects, the technical challenges of sperm preservation also present problems. Freezing and thawing sperm can lead to a loss in viability, with a significant percentage of sperm damaged in the process. According to a study from Fertility and Sterility, sperm samples can experience up to 50% damage during freezing and thawing, leading to reduced fertility outcomes.2 Furthermore, the quality of sperm collected in a medical facility may not always meet the standards required for successful fertilization, which is a concern for both sperm banks and fertility clinics.

[0025] From an ethical perspective, semen collection is a sensitive issue, as it often intersects with personal and religious beliefs about sexuality, reproduction, and the use of technology in conception. Many individuals, regardless of their religious background, may feel uneasy about the process, particularly the act of masturbation required for donation. The discomfort associated with donating semen in a clinical setting can be compounded by cultural or personal moral objections, making the process even more complex. There is a growing body of thought, however, that allowing for less invasive, more comfortable methods of collection — such as at-home donation — could ease these concerns and result in higher-quality samples, benefiting both the donors and those relying on assisted reproductive technologies.3, 4

[0026] In various aspects, the disclosure provides a kit for semen collection and filtration. The kit can include a semen collection device, a base, a first cap, a second cap, a means of generating heat, one or more fluid collection or delivery devices, and at least one means for delivering a volume of a sperm wash media. The base has a reservoir for receiving a volume of sample and having an upper opening. The first cap can be configured to attach to the upper opening of the base to form a first container. The second cap can be configured to attach to the upper opening of the base to form a second container. The second cap can include a lower surface having a filter, the filter positioned within the lower surface to contact a sample in the second container when in use. The second cap can further have an enclosed void space in contact with the filter on a side opposite the reservoir. The second cap can futher have one or more ports for inserting a liquid into the void space and / or extracting a liquid sample from the void space while the second cap is attached to the upper opening of the base.

[0027] In some aspects, the the semen collection device is a condom having one or more perforations. This is particularly useful for use by subjects who may have religious or moral objectionsto contraception. In some aspects, the first cap contains the means of generating heat. In some aspects, the sperm wash media is a preloaded syringe of HEPES opr other buffering media.

[0028] In other aspects, the disclosure provides methods of semen collection and filtration. The methods can include collecting a sample containing semen using a semen collection device and then transferring the sample to a base having a reservoir for receiving the sample and having an upper opening. Attaching a first cap to the upper opening of the base can form a first container. Proximal to attaching the first step, the method can include activating a means of generating heat to maintain the sample within a target temperature range for a period of time, wherein the activating can be manual or automatic. The methods can further include adjusting the volume of the sample in the reservoir to the desired volume and removing the first cap, wherein removing the first cap is performed proximal to the adjusting step. The method can further include attaching the second cap to the upper opening of the base to form the second container containing the desired volume of the sample and then introducing a volume of sperm wash media through a port in the second cap. The method can incude delivering the second container to a reproductive health provider and / or waiting a predetermined amount of time to allow the motile sperm to migrate into the void space and then extracting the motile sperm through a port in the second cap.

[0029] In further aspects, the disclosure provides methods of fertility treatment including providing a subject with a kit described herein and receiving a sample comprising motile sperm from the subject. The sample comprising the motile sperm can be received in a second container formed of (i) a base having a reservoir and having an upper opening and (ii) a second cap configured to attach to the upper opening of the base to form the second container.

[0030] Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present disclosure, the preferred methods and materials are now described. Functions or constructions well-known in the art may not be described in detail for brevity and / or clarity. Aspects of the present disclosure will employ, unless otherwise indicated, techniques of device fabrication, semen collection, sperm washing, sperm concentration, sperm cryopreservation, sperm morphology and motility assessment, intrauterine insemination (IUI), in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), preimplantation genetic testing (PGT), sperm genetic testing, and the like, which are within the skill of the art. Such techniques are explained fully in the literature.

[0031] It should be noted that ratios, concentrations, amounts, and other numerical data can be expressed herein in a range format. It is to be understood that such a range format is used for convenience and brevity, and thus, should be interpreted in a flexible manner to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. To illustrate, a numerical range of “about 0.1 % to about 5%” should be interpreted to include not only the explicitly recited values of about 0.1 % to about 5%, but also include individual values (e.g., 1 %, 2%, 3%, and 4%) and the sub-ranges (e.g., 0.5%, 1.1 %, 2.2%, 3.3%, and 4.4%) within the indicated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure, e.g., the phrase “x to y” includes the range from ‘x’ to ‘y’ as well as the range greater than ‘x’ and the range less than ‘y’. The range can also be expressed as an upper limit e.g., ‘about x, y, z, or less’ and should be interpreted to include the specific ranges of ‘about x’, ‘about y’, and ‘about z’ as well as the ranges of ‘less than x’, less than y’, and ‘less than z’. Likewise, the phrase ‘about x, y, z, or greater’ should be interpreted to include the specific ranges of ‘about x’, ‘about y’, and ‘about z’ as well as the ranges of ‘greater than x’, greater than y’, and ‘greater than z’. In some aspects, the term “about” can include traditional rounding according to significant figures of the numerical value. In addition, the phrase “about ‘x’ to ‘y’”, where ‘x’ and ‘y’ are numerical values, includes “about ‘x’ to about ‘y’”.

[0032] The disclosure has been organized with aide of various section headings, which are used for convenience and readability, and should not be construed in any way as limiting the disclosure or the scope of the claims. The claims may, in some instances, incorporate aspects that fall under different section headings and such combinations of aspects are understood to be encompassed by the instant disclosure.

[0033] The disclosure will be better understood with the aid of certain definitions and prescribed methods, which are described in detail in the sections entitled Definitions and Methods. Other terms and methods may be described elsewhere in the disclosure, including in the Examples, and yet others will be understood by those skilled in the art upon reading the disclosure provided herein. All definitions and methods described herein should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.Semen Collection and Filtration Kits

[0034] In various aspects, kits for semen collection and filtration are provided that overcome some of the aforementioned deficiencies. The kits can include a semen collection device, a base, a first cap, a second cap, and one or more fluid collection and delivery devices. The first cap, configured to attach to the base to form a first container, can include a means of generating heat. The second cap, configured to attach to the base to form a second container, can include a means of filtering motile sperm from a sperm sample when in the the second container.Semen Collection Device

[0035] The kit includes one or more semen collection devices. Suitable semen collection devices can include any device capable of collecting the semen while providing the appropriate levels of sterility,comfort, and usability. The semen collection device can be a condom, a cup, a pouch, or other suitable collection device. In some aspects, the semen collection device is a condom.

[0036] The semen collection device can be made of any suitable material having the appropriate levels of mechanical integrity and flexibility for the collection. The semen collection device can be made from polypropylene, polyethylene, polyester, medical-grade silicone, polystyrene, PVC, nylon, or any other suitable material. These materials are selected based on their ability to preserve sperm quality, ensure sterility, provide durability, and offer comfort for the user.

[0037] The semen collection device can be a condom. A condom, used for kits of the present disclosure, does not contain spermicides or other chemicals that are commonly used in birth control devices. In some aspects, the condoms are made from latex. However, it is believed that some latex materials may interfer with the sperm quality. Therfore, in other aspects, the condom can be made from polyurethane, polyisoprene, silicone, or polyethylene. These materials can be selected based on their ability to safely contain sperm without compromising sperm viability, while also considering factors like comfort, durability, and the prevention of allergic reactions.Base

[0038] The semen collection kit includes a base. The base is designed to receive the semen sample fro the semen collection device. The base should therefore be designed to make it simpler for the user to deposit the sample from the semen collection device into the base. In some aspects, the base attaches to the semen collection device during use such that the sample is deposited directly into the base. However, in other aspects, the base is separate from the semen collection deivce and the sample is deposited into the base from the semen collection device after the sample has been colleted. An exemplary base is depicted in FIGS. 1 -7 although the base could have any of various forns readily apparent from reading the instant disclosure. The base includes a reservoir for receiving a volume of sample and having an upper opening. The base can be made from any suitable material, preferablly one that is biocompatible and does not interfer with the sperm function.First Cap

[0039] The kit can include a first cap, which may also be referred to as an incubation cap. The first cap can serve a varierty of purposes. The first cap is configured to attach to the upper opening of the base to form a first container. The first cap can prevent contamination of the sample once collected. The first cap, in some aspects, contains a means of generating heat to heat the sample once collected. In some aspects, the first cap is insulated to prevent loss of heat from the sample in the first container. An exemplary base is depicted in FIGS. 2-3.

[0040] In some aspects, the first cap attaches to the container to define a desired volume of the sample in the container. In such aspects, the first cap can contain an overflow port allowing anyexcess sample to escape from within the reservoir as the first cap is attached to the base. The port, or a separate fill port, can also allow the reservoir to be filled to the desired volume with the first cap in place in instances where the sample volume is less than the desired volume.Second Cap

[0041] The kit can include a second cap, which may also be referred to as a filtration cap. The second cap can be configured to attach to the upper opening of the base to form a second container. The second cap provides for filtration of the sample within the reservoir.

[0042] In some aspects, the the second cap has a lower surface having a filter, the filter positioned within the lower surface to contact a sample in the second container when in use. By positioning the filter in the lower surface of the second cap, the filter is placed in contact with but above the sample in such as way that the motile sperm can migrate upword through the filter.

[0043] In some aspects, the filter includes a microfluidic filter. Microfluidic filters are composed of highly engineered polymer or glass-based materials, featuring intricate microscale channels and chambers. These structures are fabricated using precision techniques such as photolithography or micromolding, ensuring uniformity and accuracy in the pathways through which sperm navigate. The channels are can be narrow and curved to mimic the cervical and uterine environments, facilitating the selection of motile sperm capable of swimming against resistance. The materials used are often biocompatible and non-toxic, ensuring that the sperm remain viable during the process. Microfluidic filters are disposable, sterile, and designed for single-use applications, reducing the risk of contamination and ensuring consistent performance in procedures like in vitro fertilization (IVF).

[0044] In some aspects, the filter includes a membrane filter. Membrane filters are constructed from porous materials such as polycarbonate, polyethylene, or other medical-grade polymers, chosen for their durability, biocompatibility, and ability to maintain structural integrity during use. The membranes feature uniform pore sizes, typically in the micrometer range, which act as a physical barrier. These pores facilitate the separation process, allowing motile sperm to swim through while retaining immotile sperm, cellular debris, and other unwanted material. In some aspects, when using a membrane filter, the membrane filter can incorporate a layered design, enhancing the filtration efficiency by combining multiple separation stages.

[0045] In some aspects, the second cap contains an enclosed void space in contact with the filter on a side opposite the reservoir when the second cap is attached to the base. The void space provide a volume where motile sperm can migrate during the passive filtration process.

[0046] some aspects, the second cap contains one or more ports for inserting a liquid into the void space and / or extracting a liquid sample from the void space while the second cap is attached to the upper opening of the base;Fluid Collection and Dispensing Devices

[0047] The semen collection kit can include one or more devices for fluid collecting and / or dispensing. Suitable devices can include syringes, pipettes, droppers, dopper bottles, or other similar devices as are known to those skilled in the art. The fluid collection and dispensing devices can be made from biocompatible materirals to avoid negatively impacting the sample quality. In some aspects, when the device is used for dispensing a fluid such as a semen wash media, the fluid can be provided in the device in the form of a prefilled syringe, a prefilled pipette, or a prefilled dropper bottle.

[0048] In some aspects, the semen collection kit includes at least one empty fluid collection device for collecting the motile sperm after filtration. The semen collection kit can also include a second empty fluid collection device that can be used to adjust the volume of the sample to a desired sample volume. In some aspects, the empty fluid collection device is an empty syringe.

[0049] In some aspects, the semen collection kit includes at least one fluid dispensing device. In some aspects, the fluid dispensing device is prefilled with a specific volume of fluid such as a sperm wash media. The fluid dispensing device can be a prefilled syringe, a prefilled pipette, or similar device for administering an amount of fluid. In some aspects, the fluid dispensing device includes an empty fluid dispensing device and a separate container holding an amount of the fluid to be dispensed, whereby the user is instructed to first fill the fluid dispensing device with the desired amount of fluid such as sperm wash media.Sperm Wash Media

[0050] The kit can include a means of delivering a sperm wash media. Suitable means can include a syringe, a single use plastic bottle, a pre-filled pipette, a dropper bottle, or other similar means of contrallably delivering a volume of fluid. In some aspects, the means of delivering a sperm wash media is a syringe. In some aspects, the syring is provided in the kit as a preloaded syringe. A preloaded syringe can have the advantages of easier use and lower risk of contamination.

[0051] The sperm wash media can include any suitable soliution capable of preserving sperm vitality and motility, maintaining pH, and / or providing suitable energy sources for the sperm cells during transport. Conventional sperm wash media are specialized solutions used to prepare and isolate sperm from seminal fluid, non-sperm cells, and other contaminants. These media can help ensure that sperm maintain optimal viability, motility, and fertilization potential during processing. The composition of sperm wash media can include a combination of buffering agents, salts, energy sources, and other additives that provide a stable environment for sperm while mimicking the physiological conditions of the reproductive tract.

[0052] One of the key components of sperm wash media is a buffering agent, which maintains the pH of the medium within a range that is conducive to sperm survival and motility. HEPES (4-(2-hydroxyethyl)-1 -piperazineethanesulfonic acid) is one of the most commonly used buffering agents in sperm wash media due to its ability to maintain pH stability even when exposed to temperature fluctuations. HEPES is a zwitterionic buffer, meaning it does not introduce additional ions into the solution that could affect sperm function. Typically, HEPES is used at concentrations between 10-25 mM to ensure that the pH remains within a range for sperm processing (typically around pH 7.2 to 7.5).

[0053] In addition to buffering agents, salts such as sodium chloride (NaCI), potassium chloride (KCI), and calcium chloride (CaCI2) can also be included in sperm wash media to maintain osmolarity and support sperm cell membrane integrity. NaCI is the primary salt in most formulations, providing essential sodium and chloride ions to help balance osmotic pressure. KCI supports the proper ionic environment necessary for sperm motility, while CaCI2can be used for regulating sperm capacitation and acrosome reaction, which are necessary for successful fertilization. The typical concentrations of these salts, when present, range from 100 mM to 200 mM for NaCI, 5 mM to 15 mM for KCI, and 0.5 mM to 2 mM for CaCI2.

[0054] The sperm wash media can include energy sources, such as glucose or fructose, to provide sperm with the fuel necessary for motility. Glucose is widely used due to its accessibility and rapid metabolization by sperm cells, providing them with the energy required for sustained movement. Fructose, often present in higher concentrations, is another sugar that can serve as an energy source. These sugars typically range from 5 mM to 20 mM in concentration and help maintain sperm functionality during processing.

[0055] Other components that can be included in sperm wash media are antioxidants and protective agents to reduce oxidative stress, which can damage sperm DNA and impair motility. Antioxidants such as ascorbic acid (vitamin C) or glutathione are often added to protect sperm from the harmful effects of reactive oxygen species (ROS). These agents can be included at concentrations ranging from 0.1 mM to 2 mM. Additionally, amino acids like L-carnitine or taurine can be included to further support sperm metabolism and overall health during processing.

[0056] In some aspects, the sperm wash media can contain a variety of components, including buffering agents like HEPES, salts, energy sources, antioxidants, and protective agents. These ingredients can work together to create a stable and supportive environment for sperm, ensuring that they maintain their viability and motility throughout the collection and transport using kits described herein.

[0057] In some aspects, a suitable sperm wash media can include about 15mM HEPES, about 140 mM NaCL, about 5 mM KCL, about 1 mM CaCh, about 10 mM glucose, and about 1 mM ascorbic acid. In other aspects, a suitable sperm wash media can include about 20 mM HEPES, about 150mM NaCI, about 10 mM KCL, about 1.5 mM CaCh, about 15 mM Furctose, and about 1 mM hyaluronic acid.ASPECTS OF THE DISCLOSURE

[0058] The present disclosure will be better understood upon reading the following numbered aspects, which should not be confused with the claims. In some instance, the aspects below may be combined with one or more additional aspects or with other aspects described elsewhere in the disclosure and accompanying examples. All such variations and combinations are intended to be covered by the instant disclosure.Aspect 1 . A kit for semen collection and filtration, the kit containing a semen collection device.Aspect 2. The kit according to any one of Aspect 1 -Aspect 130, further comprising a base. Aspect 3. The kit according to any one of Aspect 1 -Aspect 130, further comprising first cap. Aspect 4. The kit according to any one of Aspect 1-Aspect 130, further comprising a second cap. Aspect 5. The kit according to any one of Aspect 1-Aspect 130, further comprising a means of generating heat.Aspect 6. The kit according to any one of Aspect 1-Aspect 130, further comprising one or more fluid collection or delivery devices.Aspect 7. The kit according to any one of Aspect 1-Aspect 130, further comprising at least one means for delivering a volume of a sperm wash media.Aspect 8. The kit according to any one of Aspect 1-Aspect 130, wherein the base has a reservoir for receiving a volume of sample and an upper opening.Aspect 9. The kit according to any one of Aspect 1-Aspect 130, wherein the first cap is configured to attach to the upper opening of the base to form a first container.Aspect 10. The kit according to any one of Aspect 1-Aspect 130, wherein the second cap is configured to attach to the upper opening of the base to form a second container.Aspect 11. The kit according to any one of Aspect 1-Aspect 130, wherein the second cap has a lower surface containing a filter, the filter positioned within the lower surface to contact a sample in the second container when in use.Aspect 12. The kit according to any one of Aspect 1-Aspect 130, wherein the second cap has an enclosed void space in contact with the filter on a side opposite the reservoir.Aspect 13. The kit according to any one of Aspect 1-Aspect 130, wherein the second cap has one or more ports for inserting a liquid into the void space and / or extracting a liquid sample from the void space while the second cap is attached to the upper opening of the base.Aspect 14. The kit according to any one of Aspect 1-Aspect 130, wherein the semen collection device is a condom havig one or more perforations.Aspect 15. The kit according to any one of Aspect 1-Aspect 130, wherein the second cap contains the means of generating heat.Aspect 16. The kit according to any one of Aspect 1-Aspect 130, wherein the means for delivering a volume of a sperm wash media is a preloaded syringe of HEPES buffering media.Aspect 17. The kit according to any one of Aspect 1-Aspect 130, wherein the wherein the semen collection device is selected from the group consisting of a condom, a cup, and a pouch.Aspect 18. The kit according to any one of Aspect 1 -Aspect 130, wherein the semen collection device is a condom.Aspect 19. The kit according to any one of Aspect 1 -Aspect 130, wherein the semen collection device is a cup.Aspect 20. The kit according to any one of Aspect 1 -Aspect 130, wherein the semen collection device is a pouch.Aspect 21. The kit according to any one of Aspect 1 -Aspect 130, wherein the semen collection device contains a material selected from the group consisting of polypropylene, polyethylene, polyester, medical-grade silicone, polystyrene, PVC, nylon, and a combination thereof.Aspect 22. The kit according to any one of Aspect 1 -Aspect 130, wherein the semen collection device contains polypropylene.Aspect 23. The kit according to any one of Aspect 1 -Aspect 130, wherein the semen collection device contains polyethylene.Aspect 24. The kit according to any one of Aspect 1 -Aspect 130, wherein the semen collection device contains polyester.Aspect 25. The kit according to any one of Aspect 1 -Aspect 130, wherein the semen collection device contains medical-grade silicone.Aspect 26. The kit according to any one of Aspect 1 -Aspect 130, wherein the semen collection device contains polystyrene.Aspect 27. The kit according to any one of Aspect 1 -Aspect 130, wherein the semen collection device contains PVC.Aspect 28. The kit according to any one of Aspect 1 -Aspect 130, wherein the semen collection device contains nylon.Aspect 29. The kit according to any one of Aspect 1 -Aspect 130, wherein the semen collection device includes a material selected from the group consisting of polyurethane, polyisoprene, silicone, polyethylene, and a combination thereof.Aspect 30. The kit according to any one of Aspect 1-Aspect 130, wherein the semen collection device contains polyurethane.Aspect 31. The kit according to any one of Aspect 1-Aspect 130, wherein the semen collection device contains polyisoprene.Aspect 32. The kit according to any one of Aspect 1-Aspect 130, wherein the semen collection device contains silicone.Aspect 33. The kit according to any one of Aspect 1-Aspect 130, wherein the semen collection device contains polyethylene.Aspect 34. The kit according to any one of Aspect 1-Aspect 130, wherein the semen collection device contains latex.Aspect 35. The kit according to any one of Aspect 1-Aspect 130, wherein the semen collection device does not contain latex.Aspect 36. The kit according to any one of Aspect 1-Aspect 130, wherein the semen collection device is a condom having one or more perforations.Aspect 37. The kit according to any one of Aspect 1-Aspect 130, wherein the condom contains latex.Aspect 38. The kit according to any one of Aspect 1-Aspect 130, wherein the condom does not contain latex.Aspect 39. The kit according to any one of Aspect 1 -Aspect 130, wherein the condom contains a material selected from the group consisting of polyurethane, polyisoprene, silicone, polyethylene, and a combination thereof.Aspect 40. The kit according to any one of Aspect 1-Aspect 130, wherein the condom contains polyurethane.Aspect 41. The kit according to any one of Aspect 1-Aspect 130, wherein the condom contains polyisoprene.Aspect 42. The kit according to any one of Aspect 1-Aspect 130, wherein the condom contains silicone.Aspect 43. The kit according to any one of Aspect 1-Aspect 130, wherein the condom contains polyethylene.Aspect 44. The kit according to any one of Aspect 1-Aspect 130, wherein the base contains a material selected from the group consisting of polypropylene, polyethylene, polyester, medical-grade silicone, polystyrene, PVC, nylon, and a combination thereof.Aspect 45. The kit according to any one of Aspect 1-Aspect 130, wherein the base contains polypropylene.Aspect 46. The kit according to any one of Aspect 1-Aspect 130, wherein the base contains polyethylene.Aspect 47. The kit according to any one of Aspect 1-Aspect 130, wherein the base contains polyester.Aspect 48. The kit according to any one of Aspect 1-Aspect 130, wherein the base contains medical-grade silicone.Aspect 49. The kit according to any one of Aspect 1-Aspect 130, wherein the base contains polystyrene.Aspect 50. The kit according to any one of Aspect 1-Aspect 130, wherein the base contains PVC. Aspect 51 . The kit according to any one of Aspect 1-Aspect 130, wherein the base contains nylon. Aspect 52. The kit according to any one of Aspect 1-Aspect 130, wherein the base is a shallow dish with a top end that is operable to receive multiple attachments.Aspect 53. The kit according to any one of Aspect 1-Aspect 130, wherein the base is a cylindrical container having a top opening configured to attach to the first cap and the second cap to form the first container and the second container respectively.Aspect 54. The kit according to any one of Aspect 1-Aspect 130, wherein the base contains the means of generating heat.Aspect 55. The kit according to any one of Aspect 1-Aspect 130, wherein the base contains an indicator denoting a desired volume of sample within the base.Aspect 56. The kit according to any one of Aspect 1-Aspect 130, wherein the indicator is a line of demarcation.Aspect 57. The kit according to any one of Aspect 1-Aspect 130, wherein the desired volume of sample is about 1 cubic centimeter.Aspect 58. The kit according to any one of Aspect 1-Aspect 130, wherein the desired volume of sample is between about 0.75 cubic centimeter and about 1.5 cubic centimeter.Aspect 59. The kit according to any one of Aspect 1-Aspect 130, wherein the desired volume of sample is between about 0.75 cubic centimeter and about 1.25 cubic centimeter.Aspect 60. The kit according to any one of Aspect 1-Aspect 130, wherein the desired volume of sample is between about 0.9 cubic centimeter and about 1 .2 cubic centimeter.Aspect 61. The kit according to any one of Aspect 1-Aspect 130, wherein the first cap contains the means of generating heat.Aspect 62. The kit according to any one of Aspect 1-Aspect 130, wherein the means of generating heat is not contained within the first cap.Aspect 63. The kit according to any one of Aspect 1-Aspect 130, wherein the first cap, when attached to the base to form the first container, defines a desired volume of sample in the reservoir.Aspect 64. The kit according to any one of Aspect 1-Aspect 130, wherein the first cap has an overflow port configured such that, if the reservoir contains a volume of sample greater than the desired volume of sample, an excess volume is expelled from the container through the overflow port as the first cap is attached to the base.Aspect 65. The kit according to any one of Aspect 1-Aspect 130, wherein the first cap has a fill port configured such that, if the reservoir contains a volume of sample less than the desiredvolume of sample, an amount of a sperm wash media can be added to the reservoir through the fill port while the first cap is attached to the base.Aspect 66. The kit according to any one of Aspect 1-Aspect 130, wherein the fill port and the overflow port are the same port.Aspect 67. The kit according to any one of Aspect 1-Aspect 130, wherein the fill port and the overflow port are different ports.Aspect 68. The kit according to any one of Aspect 1-Aspect 130, wherein the enclosed void space in the second cap has a volume of about 0.25 cubic centimeter to about 1 .5 cubic centimeter.Aspect 69. The kit according to any one of Aspect 1-Aspect 130, wherein the enclosed void space in the second cap has a volume of about 0.25 cubic centimeter to about 1 cubic centimeter.Aspect 70. The kit according to any one of Aspect 1-Aspect 130, wherein the enclosed void space in the second cap has a volume of about 0.5 cubic centimeter to about 1.5 cubic centimeter.Aspect 71 . The kit according to any one of Aspect 1-Aspect 130, wherein the enclosed void space in the second cap has a volume of about 0.25 cubic centimeter to about .75 cubic centimeter.Aspect 72. The kit according to any one of Aspect 1-Aspect 130, wherein the enclosed void space in the second cap has a volume of about 0.75 cubic centimeter to about 1 .5 cubic centimeter.Aspect 73. The kit according to any one of Aspect 1-Aspect 130, wherein the enclosed void space in the second cap has a volume of about 0.8 cubic centimeter to about 1.2 cubic centimeter.Aspect 74. The kit according to any one of Aspect 1-Aspect 130, wherein the one or more ports of the second cap includes an insertion port and an extraction port.Aspect 75. The kit according to any one of Aspect 1-Aspect 130, wherein the one or more ports of the second cap includes a single port used for both insertion and extraction.Aspect 76. The kit according to any one of Aspect 1-Aspect 130, wherein the means of generating heat includes a means selected from the group consisting of a self-heating pad, a battery- powered heating element, a warming gel, and a combination thereof.Aspect 77. The kit according to any one of Aspect 1-Aspect 130, wherein the means of generating heat includes a self-heating pad.Aspect 78. The kit according to any one of Aspect 1-Aspect 130, wherein the means of generating heat includes a battery-powered heating element.Aspect 79. The kit according to any one of Aspect 1-Aspect 130, wherein the means of generating heat includes a warming gel.Aspect 80. The kit according to any one of Aspect 1-Aspect 130, wherein the means of generating heat includes a self-heating pad having iron powder, salt, water, and activated carbon.Aspect 81 . The kit according to any one of Aspect 1-Aspect 130, wherein the means of generating heat includes a battery-powered heating element having a thermal control to maintain a sample in the reservoir within a target temperature range for a period of time.Aspect 82. The kit according to any one of Aspect 1-Aspect 130, wherein the means of generating heat includes a warming gel that can be heated prior to use and retains heat for an extended period of time to maintain a sample in the reservoir within a target temperature range.Aspect 83. The kit according to any one of Aspect 1-Aspect 130, wherein the one or more fluid collection or delivery devices include one or more syringes, pipettes, droppers, or a combination thereof.Aspect 84. The kit according to any one of Aspect 1-Aspect 130, wherein the one or more fluid collection or delivery devices include one or more syringes.Aspect 85. The kit according to any one of Aspect 1-Aspect 130, wherein the one or more fluid collection or delivery devices include one or more pipettes.Aspect 86. The kit according to any one of Aspect 1-Aspect 130, wherein the one or more fluid collection or delivery devices include one or more droppers.Aspect 87. The kit according to any one of Aspect 1-Aspect 130, wherein the means of generating heat includes a heated pouch or container that the first container is placed in to maintain a temperature within a target temperature range for a period of time.Aspect 88. The kit according to any one of Aspect 1-Aspect 130, wherein the means for delivering a volume of a sperm wash media includes a prefilled syringe containing the sperm wash media.Aspect 89. The kit according to any one of Aspect 1-Aspect 130, wherein the means for delivering a volume of a sperm wash media includes a syringe, a single use plastic bottle, a pre-filled pipette, a dropper bottle, or a combination thereof.Aspect 90. The kit according to any one of Aspect 1-Aspect 130, wherein the means for delivering a volume of a sperm wash media includes a syringe.Aspect 91 . The kit according to any one of Aspect 1-Aspect 130, wherein the means for delivering a volume of a sperm wash media includes a single use plastic bottle.Aspect 92. The kit according to any one of Aspect 1-Aspect 130, wherein the means for delivering a volume of a sperm wash media includes a pre-filled pipette.Aspect 93. The kit according to any one of Aspect 1-Aspect 130, wherein the means for delivering a volume of a sperm wash media includes a dropper bottle.Aspect 94. The kit according to any one of Aspect 1-Aspect 130, wherein the sperm wash media includes a buffering agent.Aspect 95. The kit according to any one of Aspect 1-Aspect 130, wherein the buffering agent is selected from the group consisting of 4-(2-hydroxyethyl)-1 -piperazineethanesulfonic acid (HEPES), phosphate-buffered saline, tris(hydroxymethyl)aminomethane (TRIS), 3-(N- Morpholino)propanesulfonic acid (MOPS), N-Tris(hydroxymethyl)methyl-2- aminoethanesulfonic acid (TES), and a combination thereof.Aspect 96. The kit according to any one of Aspect 1-Aspect 130, wherein the buffering agent is 4- (2-hydroxyethyl)-1-piperazineethanesulfonic acid (HEPES).Aspect 97. The kit according to any one of Aspect 1-Aspect 130, wherein the buffering agent is phosphate-buffered saline.Aspect 98. The kit according to any one of Aspect 1-Aspect 130, wherein the buffering agent is tris(hydroxymethyl)aminomethane (TRIS).Aspect 99. The kit according to any one of Aspect 1-Aspect 130, wherein the buffering agent is 3- (N-Morpholino)propanesulfonic acid (MOPS).Aspect 100. The kit according to any one of Aspect 1-Aspect 130, wherein the buffering agent is N-Tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid (TES).Aspect 101. The kit according to any one of Aspect 1-Aspect 130, wherein the sperm wash media includes one or more of a buffering agent, a salt, an energy source, an antioxidant, and a protective agent.Aspect 102. The kit according to any one of Aspect 1 -Aspect 130, wherein the sperm wash media includes a buffering agent.Aspect 103. The kit according to any one of Aspect 1 -Aspect 130, wherein the sperm wash media includes a salt.Aspect 104. The kit according to any one of Aspect 1 -Aspect 130, wherein the sperm wash media includes an energy source,.Aspect 105. The kit according to any one of Aspect 1 -Aspect 130, wherein the sperm wash media includes an antioxidant.Aspect 106. The kit according to any one of Aspect 1 -Aspect 130, wherein the sperm wash media includes a protective agent.Aspect 107. The kit according to any one of Aspect 1-Aspect 130, wherein the buffering agent is selected from the group consisting of 4-(2-hydroxyethyl)-1 -piperazineethanesulfonic acid (HEPES), phosphate-buffered saline, tris(hydroxymethyl)aminomethane (TRIS), 3-(N- Morpholino)propanesulfonic acid (MOPS), N-Tris(hydroxymethyl)methyl-2- aminoethanesulfonic acid (TES), and a combination thereof.Aspect 108. The kit according to any one of Aspect 1-Aspect 130, wherein the salt is selected from the group consisting of sodium chloride, potassium chloride, calcium chloride, and a combination thereof.Aspect 109. The kit according to any one of Aspect 1 -Aspect 130, wherein the salt is sodium chloride.Aspect 110. The kit according to any one of Aspect 1-Aspect 130, wherein the salt is potassium chloride.Aspect 111. The kit according to any one of Aspect 1 -Aspect 130, wherein the salt is calcium chloride.Aspect 112. The kit according to any one of Aspect 1 -Aspect 130, wherein the energy source is selected from the group consisting of glucose, fructose, and a combination thereof.Aspect 113. The kit according to any one of Aspect 1 -Aspect 130, wherein the energy source is glucose.Aspect 114. The kit according to any one of Aspect 1 -Aspect 130, wherein the energy source is fructose.Aspect 115. The kit according to any one of Aspect 1 -Aspect 130, wherein the antioxidant is selected from the group consisting of ascorbic acid, glutathione, and a combination thereof.Aspect 116. The kit according to any one of Aspect 1 -Aspect 130, wherein the antioxidant is ascorbic acid.Aspect 117. The kit according to any one of Aspect 1 -Aspect 130, wherein the antioxidant is glutathione.Aspect 118. The kit according to any one of Aspect 1 -Aspect 130, wherein the protective agent is selected from the group consisting of L-carnitine, taurine, and a combination thereof.Aspect 119. The kit according to any one of Aspect 1 -Aspect 130, wherein the protective agent is L-carnitine.Aspect 120. The kit according to any one of Aspect 1-Aspect 130, wherein the protective agent is taurine.Aspect 121. The kit according to any one of Aspect 1-Aspect 130, further including instructions to collect a sample comprising semen using the semen collection device.Aspect 122. The kit according to any one of Aspect 1-Aspect 130, further including instructions to transfer the sample into the reservoir of the base.Aspect 123. The kit according to any one of Aspect 1-Aspect 130, further including instructions to attach the first cap to the upper opening of the base to form the first container containing the sample.Aspect 124. The kit according to any one of Aspect 1-Aspect 130, further including instructions to activate, whether automatically or manually, the means of generating heat, wherein the activation step is performed proximal to the attaching step.Aspect 125. The kit according to any one of Aspect 1-Aspect 130, further including instructions to allow the first container to be exposed to heat from the means of generating heat for a first period of time.Aspect 126. The kit according to any one of Aspect 1-Aspect 130, further including instructions to adjust the volume of the sample in the reservoir to a desired volume.Aspect 127. The kit according to any one of Aspect 1-Aspect 130, further including instructions to remove the first cap, wherein removing the first cap is performed proximal to the adjusting step.Aspect 128. The kit according to any one of Aspect 1-Aspect 130, further including instructions to attach the second cap to the upper opening of the base to form the second container containing the desired volume of the sample.Aspect 129. The kit according to any one of Aspect 1-Aspect 130, further including instructions to introduce a volume of sperm wash media through a port in the second cap.Aspect 130. The kit according to any one of Aspect 1-Aspect 130, wherein the semen collection device includes a condom having one or more perforations; and wherein the instructions include instructions to use the condom during vaginal intercourse.Aspect 131. A method of fertility treatment, the method comprising collecting a sample comprising semen using a semen collection device.Aspect 132. The method according to any one of Aspect 131-Aspect 143, further involving transferring the sample to a base comprising a reservoir for receiving the sample and having an upper opening.Aspect 133. The method according to any one of Aspect 131-Aspect 143, further involving attaching a first cap to the upper opening of the base to form a first container.Aspect 134. The method according to any one of Aspect 131-Aspect 143, further involving proximal to the attaching step, activating a means of generating heat to maintain the sample within a target temperature range for a period of time, wherein the activating can be manual or automatic.Aspect 135. The method according to any one of Aspect 131-Aspect 143, further involving adjusting the volume of the sample in the reservoir to the desired volume of sample.Aspect 136. The method according to any one of Aspect 131-Aspect 143, further involving removing the first cap, wherein removing the first cap is performed proximal to the adjusting step.Aspect 137. The method according to any one of Aspect 131-Aspect 143, further involving attaching a second cap to the upper opening of the base to form the second container containing the desired volume of the sample.Aspect 138. The method according to any one of Aspect 131-Aspect 143, further involving introducing a volume of sperm wash media into a void space in the second cap through a port.Aspect 139. The method according to any one of Aspect 131-Aspect 143, further involving delivering the second container to a reproductive health provider.Aspect 140. The method according to any one of Aspect 131 -Aspect 143, wherein the semen collection device comprises a condom comprising one or more perforations; and the method comprises using the condom during vaginal intercourse.Aspect 141. The method according to any one of Aspect 131-Aspect 143, further involving waiting a predetermined amount of time to allow motile sperm from the sample to migrate into the void space.Aspect 142. The method according to any one of Aspect 131-Aspect 143, further involving extracting the motile sperm from the filtered sample through a port in the second cap.Aspect 143. The method according to any one of Aspect 131-Aspect 143, wherein the method is performed using a kit according to any one of Aspect 1 -Aspect 130.Aspect 144. A method of performing a fertility treatment, the method including receiving a sample containg semen, the sample contained in a second container.Aspect 145. The method according to any one of Aspect 144-Aspect 151 , wherein the second container is formed of a base having a reservoir and having an upper opening, and a second cap configured to attach to the upper opening of the base to form the second container.Aspect 146. The method according to any one of Aspect 144-Aspect 151 , further involving extracting motile sperm through a port in the second cap.Aspect 147. The method according to any one of Aspect 144-Aspect 151 , wherein the motile sperm is located in an enclosed void space of the second cap.Aspect 148. The method according to any one of Aspect 144-Aspect 151 , wherein the enclosed void space is in contact with a filter on a side opposite the reservoir.Aspect 149. The method according to any one of Aspect 144-Aspect 151 , further involving using the motile sperm in a fertility treatment.Aspect 150. The method according to any one of Aspect 144-Aspect 151 , further comprising providing a subject with a kit according to any one of Aspect 1 -Aspect 130.Aspect 151. The method according to any one of Aspect 144-Aspect 151 , further comprising receiving a sample comprising motile sperm from the subject.EXEMPLARY KITS

[0059] Now having described the aspects of the present disclosure, in general, the following exemplary kits describe some additional aspects of the present disclosure. While aspects of the present disclosure are described in connection with the following exemplary kits and the corresponding text and figures, there is no intent to limit aspects of the present disclosure to this description. On the contrary, the intent is to cover all alternatives, modifications, and equivalentsincluded within the spirit and scope of the present disclosure. Efforts have been made to ensure accuracy with respect to numbers e.g., amounts, temperature, etc.), but some errors and deviations should be accounted for. Unless indicated otherwise, parts are parts by weight, temperature is in °C or is at ambient temperature, and pressure is at or near atmospheric.Examplary Kit 1

[0060] FIGS. 1-7 depcit components and methods of an exemplary kit for semen collection and filtration. The kit contains a condom 100 having a number of perforations 105. Perforations 105 are included to address certain religious prohibitions on the use of contraceptives, as perforations 105 allow some semen to exit condom 100 while the couple is engaged in intercourse while simultaneously capturing some portion of the male’s ejaculate. The base 150 is a shallow dish having a reservoir 152 with an upper opening 154 that is operable to receive multiple attachments. In some aspects, the base 150 can be insulated. The semen sample can be collected in the condom 100 and then emptied into the reservoir 152 of the base 150.

[0061] The exemplary kit can include a first cap 200. As depicted in FIG. 2, once the semen sample 210 is deposited into the reservoir 152 of the base 150, incubator cap 200 is attached over the upper opening 154 in the base 150 to form a frst container 250. In exemplary aspects, incubator cap 200 is screwed to base 150 via threads; in alternative asoects, incubator cap 200 is affixed vis interlocking grooves. Other ordinary means of removably securing attachment can also be used.

[0062] Semen collection kit further includes one or more fluid collection or delivery devices (see, e.g., syringe 600). In some aspects, semen collection kit shall include one or more syringes that are initially empty for use in the removal of excess semen from sample 210, and one or more syringes that are preloaded with a sperm wash medium.

[0063] The exemplary semen collection kit further includes a second cap 300 for filtration. Thje second cap 300 incliudes a lower surface 315 having a filter 310. The filter 310 positioned within the lower surface 315 to contact a sample 210 in the second container when in use. The second cap 300 includes an enclosed void space 330 in contact with the filter on a side opposite the reservoir 152. The second cap 300 further includes one or more ports 320 for inserting a liquid into the void space 330 and / or extracting a liquid sample from the void space 330 while the second cap 300 is attached to the upper opening 154 of the base 150. In some aspects, the upper cap 300 has only a single port 320 used for both insertion and extraction. Whereas, in other aspects, the upper cap 300 can have separate insertion and extraction ports 320.

[0064] Similar to first cap 200, second cap 300 is configured to attached to base 150 via known attachment methods such as threaded grooves, interlocking grooves, snap-in ridges, or other knownattachment methods. In some aspects, second cap 300 is insulated to maintain a constant temperature inside base 150 when the second cap 300 is attached to base 150.

[0065] The kit can be used via the following steps and procedures. First, a couple would engage in normal vaginal intercourse while the male wears condom 100. Once intercourse is complete, whatever semen is collected in condom 100 is emptied into the reservoir 152 of base 150 (see FIG. 1 ). The first cap 200 is then attached to base 150 (see FIG. 2), thereby sealing semen sample 210 inside of the container 250 formed by cap 200 and base 150. Either prior to, during, or directly after cap 200 is attached to base 150, the heating mechanism inside of cap 200 is activated (either automatically or manually). The activation is then operable to maintain a desired temperature such as about 98.6° F inside of container 250.

[0066] Once the first cap 200 is attached and the heating element is activated, the sample 210 is left undisturbed for a period of time (e.g. approximately 20 minutes) to allow sample 210 to liquify. After the liquefaction period has elapsed, the first cap 200 is removed (see FIG. 3).

[0067] Upon removing the first cap 200, the volume of sample 210 is measured to determine whether it is equal to a desried volume (e.g. about 1 cubic centimeter). In some aspects, a line of demarcation 410 or other indicator is provided inside of base 150 that indicates a fluid level equal to a desired volume. If, after liquification, sample 210 is greater than the desired volume, then an empty syringe can be used to remove excess semen until the volume of fluid in the reservoir 152 of base 150 is at the desired volume. If, after liquification, sample 210 is less than the desired volume, then a pre- loaded syringe of sperm wash mediu can be at the desired volume.

[0068] Once the volume of liquid in the reservoir 152 of base 150 is equal to 1the desired volume, the second cap 300 is attached to base 150, thereby creating container 350. Once second cap 300 is attached to base 150, sperm wash medium is added through port 320 into the void space 330 of the cap 300. This newly-added sperm wash medium then migrates downward into filter 310, thereby saturating filter 310 with sperm wash medium. Once added, semen sample 210 undergoes a passive filtration process whereby motile sperm migrate upward through filter 310 to the top of filtration cap 310 and into the void space 330, thereby creating filtered sample 750 via filter 310, where filtered sample 750 will be suitable for use in a fertility treatment. The filtration process takes a period of time (e.g. approximately 30 minutes) once the sperm wash media is applied.

[0069] In some aspects, the second cap 300 is sized so that bottom surface 315 is aligned with line of demarcation 410 when filtration cap 300 is attached to base 150 such that bottom surface 315 comes into contact with sample 210. In an exemplary aspects, filter 310 is similar to sperm separation filters offered by ZyMot®.

[0070] The filtered sample 750 can be extracted from filtration cap 300 via a port 320, at which point filtered sample 750 is immediately ready for use in a fertility treatment, thereby eliminating (or at least greatly reducing) wait times at the fertility clinic for the couple seeking treatment.

[0071] In an alternative embodiment, an IUI catheter (not shown) is attached directly to a port 320, and filtered sample 750 is then directly administered to a uterus, thereby minimizing environmental exposure to sample 750 while also minimizing accidental spillage or other loss during extraction.REFERENCES

[0072] Unless specified elsewhere in the disclosure, references cited in the disclosure are enumerated below. References may be cited herein using the format of reference number(s) enclosed by parentheses corresponding to one or more of the following numbered references. References may also be cited herein using a superscript format. For example, citation of references numbers 1 and 2 immediately herein below could be indicated in the disclosure as (Refs. 1 and 2) or as the superscript » 1 -2

[0073] All publications and patents cited in this specification are cited to disclose and describe the methods and / or materials in connection with which the publications are cited. All such publications and patents are herein incorporated by references as if each individual publication or patent were specifically and individually indicated to be incorporated by reference. Such incorporation by reference is expressly limited to the methods and / or materials described in the cited publications and patents and does not extend to any lexicographical definitions from the cited publications and patents. Any lexicographical definition in the publications and patents cited that is not also expressly repeated in the instant specification should not be treated as such and should not be read as defining any terms appearing in the accompanying claims. Furthermore, any incorporation by reference of patents and patent applications to which the instant application claims priority is not intended to extend to any lexicographical definitions in the patents and patent applications so incorporated and should not be read as limiting the accompanying claims.

[0074] The citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure. Further, the dates of publication provided could be different from the actual publication dates that may need to be independently confirmed.1 . Scaruffi, P. etal. P-072 Collecting semen samples at home for fertility assessment has a positive effect on sperm quality. Hum. Reprod. 37, dead 07.068 (2022).2. Meseguer, M. et al. Parameters affecting sperm survival after thawing in long-term frozen storage.Fertil. Steril. 76, S119 (2001 ).3. Samplaski, M. K. et al. Development and validation of a novel mail-in semen analysis system and the correlation between one hour and delayed semen analysis testing. Fertil. Steril. 115, 922-929 (2021 ).4. Agarwal, A. et al. Home sperm testing device versus laboratory sperm quality analyzer: comparison of motile sperm concentration. Fertil. Steril. 110, 1277-1284 (2018).

[0075] It should be emphasized that the above-described aspects of the present disclosure are merely possible examples of implementations, and are set forth only for a clear understanding of the principles of the disclosure. Many variations and modifications may be made to the above-described aspects of the disclosure without departing substantially from the spirit and principles of the disclosure. All such modifications and variations are intended to be included herein within the scope of this disclosure. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the disclosure being indicated by the following claims.

Claims

We claim:1 . A kit for semen collection and filtration, the kit comprising: a. a semen collection device; b. a base comprising a reservoir for receiving a volume of sample and having an upper opening; c. a first cap configured to attach to the upper opening of the base to form a first container; d. a second cap configured to attach to the upper opening of the base to form a second container, the second cap comprising: i. a lower surface comprising a filter, the filter positioned within the lower surface to contact a sample in the second container when in use; ii. an enclosed void space in contact with the filter on a side opposite the reservoir; iii. one or more ports for inserting a liquid into the void space and / or extracting a liquid sample from the void space while the second cap is attached to the upper opening of the base; e. a means of generating heat; f. one or more fluid collection or delivery devices; and g. at least one means for delivering a volume of a sperm wash media.

2. The kit according to claim 1 , wherein the semen collection device comprises a condom comprising one or more perforations; wherein the first cap comprises the means of generating heat; wherein the means for delivering a volume of a sperm wash media comprises a preloaded syringe of HEPES buffering media.

3. The kit according to claim 1 , wherein the semen collection device is selected from the group consisting of a condom, a cup, and a pouch.

4. The kit according to claim 1 , wherein the semen collection device is a condom.

5. The kit according to any one of claims 1 and 3-4, wherein the semen collection device comprises a material selected from the group consisting of polypropylene,polyethylene, polyester, medical-grade silicone, polystyrene, PVC, nylon, and a combination thereof.

6. The kit according to any one of claims 1 and 3-4, wherein the semen collection device comprises a material selected from the group consisting of polyurethane, polyisoprene, silicone, polyethylene, and a combination thereof.

7. The kit according to any one of claims 1 and 3-4, wherein the semen collection device comprises latex.

8. The kit according to any one of claims 1 and 3-4, wherein the semen collection device does not comprise latex.

9. The kit according to claim 1 , wherein the semen collection device comprises a condom comprising one or more perforations.

10. The kit according to claim 9, wherein the condom comprises latex.

11. The kit according to claim 9, wherein the condom does not comprise latex.

12. The kit according to any one of claims 9-11 , wherein the condom comprises a material selected from the group consisting of polyurethane, polyisoprene, silicone, polyethylene, and a combination thereof.

13. The kit according to any one of claims 1-4 and 9-11 , wherein the base comprises a material selected from the group consisting of polypropylene, polyethylene, polyester, medical-grade silicone, polystyrene, PVC, nylon, and a combination thereof.

14. The kit according to any one of claims 1-4 and 9-11 , wherein the base comprises a shallow dish with a top end that is operable to receive multiple attachments.

15. The kit according to any one of claims 1-4 and 9-11 , wherein the base comprises a cylindrical container having a top opening configured to attach to a cap from the one or more caps to form the at least one container.

16. The kit according to any one of claims 1-4 and 9-11 , wherein the base comprises the means of generating heat.

17. The kit according to any one of claims 1-4 and 9-11 , wherein the base comprises an indicator denoting a desired volume of sample within the base.

18. The kit according to claim 17, wherein the indicator is a line of demarcation.

19. The kit according to any one of claims 17-18, wherein the desired volume is about 1 cubic centimeter.

20. The kit according to any one of claims 1-4 and 9-11 , wherein the first cap comprises the means of generating heat.

21. The kit according to any one of claims 1-4 and 9-11 , wherein the means of generating heat is not contained within the first cap.

22. The kit according to any one of claims 1-4 and 9-11 , wherein the first cap, when attached to the base to form the first container, defines a desired volume in the reservoir; wherein the first cap comprises an overflow port configured such that, if the reservoir contains a volume of sample greater than the desired volume, an excess volume is expelled from the container through the overflow port as the first cap is attached to the base; and wherein the first cap comprises a fill port configured such that, if the reservoir contains a volume of sample less than the desired volume, an amount of a sperm wash media can be added to the reservoir through te fill port while the first cap is attached to the base.

23. The kit according to claim 22, wherein the desired volume is about 1 cubic centimeter.

24. The kit according to any one of claims 1-4 and 9-11 , wherein the enclosed void space in the second cap has a volume of about 0.75 cc to about 1 .5 cc.

25. The kit according to any one of claims 1-4 and 9-11 , wherein the one or more ports of the second cap comprises an insertion port and an extraction port.

26. The kit according to any one of claims 1-4 and 9-11 , wherein the means of generating heat comprises a means selected from the group consisting of a selfheating pad, a battery-powered heating element, a warming gel, and a combination thereof.

27. The kit according to claim 26, wherein the means of generating heat comprises a self-heating pad comprising iron powder, salt, water, and activated carbon.

28. The kit according to claim 26, wherein the means of generating heat comprises a battery-powered heating element comprising a thermal control to maintain a sample in the reservoir within a target temperature range for a period of time.

29. The kit according to claim 26, wherein the means of generating heat comprises a warming gel that can be heated prior to use and retains heat for an extended period of time to maintain a sample in the reservoir within a target temperature range.

30. The kit according to any one of claims 1-4 and 9-11 , wherein the one or more fluid collection or delivery devices comprise one or more syringes, pipettes, droppers, or a combination thereof.

31. The kit according to any one of claims 1-4 and 9-11 , wherein the means of generating heat comprises a heated pouch or container that the first container is placed in to maintain a temperature within a target temperature range for a period of time.

32. The kit according to any one of claims 1-4 and 9-11 , wherein the means for delivering a volume of a sperm wash media comprises a prefilled syringe comprising the sperm wash media.

33. The kit according to any one of claims 1-4 and 9-11 , wherein the means for delivering a volume of a sperm wash media comprises a syringe, a single use plastic bottle, a pre-filled pipette, a dropper bottle, or a combination thereof.

34. The kit according to any one of claims 1-4 and 9-11 , wherein the sperm wash media comprises a buffering agent.

35. The kit according to claim 34, wherein the buffering agent is selected from the group consisting of 4-(2-hydroxyethyl)-1 -piperazineethanesulfonic acid (HEPES), phosphate-buffered saline, tris(hydroxymethyl)aminomethane (TRIS), 3-(N- Morpholino)propanesulfonic acid (MOPS), N-Tris(hydroxymethyl)methyl-2- aminoethanesulfonic acid (TES), and a combination thereof.

36. The kit according to any one of claims 1-4 and 9-11 , wherein the sperm wash media comprises one or more of a buffering agent, a salt, an energy source, an antioxidant, and a protective agent.

37. The kit according to claim 36, wherein the buffering agent is selected from the group consisting of 4-(2-hydroxyethyl)-1 -piperazineethanesulfonic acid (HEPES),phosphate-buffered saline, tris(hydroxymethyl)aminomethane (TRIS), 3-(N- Morpholino)propanesulfonic acid (MOPS), N-Tris(hydroxymethyl)methyl-2- aminoethanesulfonic acid (TES), and a combination thereof.

38. The kit according to claim 36, wherein the salt is selected from the group consisting of sodium chloride, potassium chloride, calcium chloride, and a combination thereof.

39. The kit according to claim 36, wherein the energy source is selected from the group consisting of glucose, fructose, and a combination thereof.

40. The kit according to claim 36, wherein the antioxidant is selected from the group consisting of ascorbic acid, glutathione, and a combination thereof.

41. The kit according to claim 36, wherein the protective agent is selected from the group consisting of L-carnitine, taurine, and a combination thereof.

42. The kit according to any one of claims 1-4 and 9-11 , further comprising instructions to: a. collect a sample comprising semen using the semen collection device; b. transfer the sample into the reservoir of the base; c. attach the first cap to the upper opening of the base to form the first container containing the sample; d. activate, whether automatically or manually, the means of generating heat, wherein the activation step (d) is performed proximal to the attaching step (c); e. allow the first container to be exposed to heat from the means of generating heat for a first period of time; f. adjust the volume of the sample in the reservoir to a desired volume; g. remove the first cap, wherein removing the first cap is performed proximal to the adjusting step (f); h. attach the second cap to the upper opening of the base to form the second container containing the desired volume of the sample; and i. introduce a volume of sperm wash media through a port in the second cap.

43. The kit according to claim 42, wherein the semen collection device comprises a condom comprising one or more perforations; andwherein the instructions comprise at step (a), instructions to use the condom during vaginal intercourse.

44. A method of fertility treatment, the method comprising: a. collecting a sample comprising semen using a semen collection device; b. transferring the sample to a base comprising a reservoir for receiving the sample and having an upper opening; c. attaching a first cap to the upper opening of the base to form a first container; d. proximal to the attaching step (c), activating a means of generating heat to maintain the sample within a target temperature range for a period of time, wherein the activating can be manual or automatic; e. adjusting the volume of the sample in the reservoir to the desired volume; f. removing the first cap, wherein removing the first cap is performed proximal to the adjusting step (e); g. attaching a second cap to the upper opening of the base to form the second container containing the desired volume of the sample; and h. introducing a volume of sperm wash media into a void space in the second cap through a port.

45. The method according to claim 44, further comprising delivering the second container to a reproductive health provider.

46. The method according to claim 44, wherein the semen collection device comprises a condom comprising one or more perforations; and wherein the method comprises at step (a) using the condom during vaginal intercourse.

47. The method according to claim 44, further comprising: i. waiting a predetermined amount of time to allow motile sperm from the sample to migrate into the void space, and j. extracting the motile sperm through a port in the second cap.

48. A method of performing a fertility treatment, the method comprising:a. receiving a sample comprising semen, the sample contained in a second container formed of: i. a base comprising a reservoir and having an upper opening, and ii. a second cap configured to attach to the upper opening of the base to form the second container; b. extracting motile sperm through a port in the second cap, the motile sperm located in an enclosed void space of the second cap, the enclosed void space in contact with a filter on a side opposite the reservoir; and c. using the motile sperm in a fertility treatment.

49. A method of performing a fertility treatment, the method comprising: a. providing a subject with a kit according to any one of claims 1-43; b. receiving a sample comprising motile sperm from the subject.

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