System for assisted prediction of in vitro fertilization pregnancy probability based on androgen response elasticity

By assessing androgen response resilience and age, and calculating androgen response parameters, the probability of IVF pregnancy during ovarian stimulation can be predicted. This addresses the shortcomings of individual androgen sensitivity assessment, thereby improving IVF success rates and optimizing personalized treatment plans.

CN119943426BActive Publication Date: 2025-12-30GUANGDONG GENERAL HOSPITAL
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Patent Information

Application Number
CN202510008879.2
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-01-02
Publication Date
2025-12-30
Estimated Expiration
2045-01-02

AI Technical Summary

Technical Problem

Current technologies lack effective methods to assess individual androgen sensitivity and its impact on ovarian function, resulting in inaccurate prediction of IVF success rates in the field of assisted reproduction, a lack of personalized treatment plans, and a waste of medical resources.

Method used

By assessing the androgen response elasticity of subjects and combining it with their age, and calculating androgen response elasticity parameters, we can predict the probability of IVF pregnancy during ovarian stimulation, provide personalized treatment recommendations, and optimize treatment plans.

Benefits of technology

It has improved the success rate of IVF, reduced unnecessary waste of medical resources, provided more accurate and personalized treatment plans, and avoided the shortcomings of doctors' subjective judgment.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application discloses a system for predicting and evaluating the probability of in vitro fertilization pregnancy based on androgen response elasticity, which comprises a data acquisition module and an androgen response elasticity calculation module; the data acquisition module is used for acquiring the age of a subject and androgen levels at different stages; and the androgen response elasticity calculation module is used for calculating androgen response elasticity parameters according to the androgen levels at different stages, and obtaining the probability of in vitro fertilization pregnancy during ovary stimulation according to the androgen response elasticity parameters and the age of the subject.
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Description

Technical Field

[0001] This invention belongs to the field of assisted reproductive technology for predicting and assessing the probability of pregnancy through in-vitro fertilization, and particularly relates to a system for predicting and assessing the probability of pregnancy through in-vitro fertilization based on androgen response elasticity. Background Technology

[0002] In the field of assisted reproduction, the success rate of in-vitro fertilization (IVF) is closely related to the subject's ovarian response, androgen levels, and other physiological factors. In ovulation induction treatment, the GnRHa (gonadotropin-releasing hormone receptor agonist) long protocol is one of the common methods for ovarian stimulation, used to increase the number of available mature oocytes, thereby increasing the probability of successful conception. However, the ovarian response to ovulation-inducing drugs varies significantly among different patients, and ovarian function or response may be affected by hormone levels.

[0003] Currently, assessing ovarian function and predicting IVF success rates mainly relies on methods such as subject age, antral follicle count (AFC), anti-Müllerian hormone (AMH) levels, and basal follicle-stimulating hormone (FSH) levels. However, these indicators primarily reflect ovarian reserve function, indicating differences in fertility within a population, and cannot predict the individual's probability of pregnancy after ovulation induction. For example, many studies have found that AMH levels cannot predict IVF pregnancy outcomes. Recent research indicates that for women with normal AMH levels, dynamic changes in androgen levels can accurately predict pregnancy outcomes during GnRHa long protocol treatment. Appropriate androgen levels can promote follicle development and improve egg quality, which has potential value in improving IVF results. Furthermore, in the past, clinicians, based on their own experience, often selected different treatment regimens under the long protocol of ovulation induction to regulate androgen levels in subjects with normal AMH levels in order to improve ovarian response and fertility potential, which involved a degree of subjectivity and a lack of clear quantitative indicators. In summary, there is currently a lack of effective methods to assess an individual's sensitivity to androgens and their impact on ovarian function, which limits the application and development of androgen levels in the field of assisted reproduction. Summary of the Invention

[0004] To address the aforementioned technical problems, this invention proposes a system for assisting in the prediction and assessment of pregnancy probability through in vitro fertilization based on androgen response elasticity, thereby resolving the issues present in the prior art.

[0005] To address the aforementioned issues, this invention proposes a novel method and system for assisting in the prediction and assessment of in vitro fertilization (IVF) pregnancy probability. The aim is to more accurately predict the IVF pregnancy probability during ovarian stimulation by assessing the subject's androgen response elasticity and combining this with the subject's age. This system is expected to provide personalized treatment recommendations and offer guiding data for optimizing treatment plans, thereby helping to improve IVF success rates and reduce unnecessary waste of medical resources.

[0006] To achieve the above objectives, this invention provides a system for auxiliary prediction and assessment of pregnancy probability in in-vitro fertilization based on androgen response elasticity, comprising:

[0007] The system includes a data acquisition module and a module for calculating androgen response elasticity. The data acquisition module is used to collect the subject's age and androgen levels at different stages. The module for calculating androgen response elasticity is used to calculate androgen response elasticity parameters based on the androgen levels collected at different stages, and to obtain the probability of pregnancy through in vitro fertilization during ovarian stimulation based on the androgen response elasticity parameters and the subject's age.

[0008] Optionally, in the data acquisition module, the androgen levels at different stages include the initial stage testosterone level, the serum testosterone level when the follicle diameter is 10-12 mm, and the serum testosterone level on the day of HCG injection.

[0009] Optionally, in the module for calculating androgen response elasticity, the process for obtaining the androgen response elasticity parameter is as follows:

[0010]

[0011] Wherein, TRE1 and TRE2 represent different parameters used to characterize the androgen response elasticity of the subjects, namely the first androgen response elasticity parameter and the second androgen response elasticity parameter, respectively, where T0 is the initial serum testosterone level, T... 10-12 Serum testosterone levels when follicle diameter is 10–12 mm, T HCG Data on serum testosterone levels on the day of HCG injection.

[0012] Optionally, in the androgen response elasticity calculation module, the probability of in vitro fertilization during ovarian stimulation is obtained based on the androgen response elasticity parameter and the subject's age. Specifically, the androgen response elasticity and the subject's age are graded and assigned values, and the probability of in vitro fertilization during ovarian stimulation is calculated based on the graded assignment results corresponding to the androgen response elasticity and age.

[0013] Optionally, in the module for calculating androgen response elasticity, the calculation process for the probability of pregnancy p during in vitro fertilization during ovarian stimulation is as follows:

[0014]

[0015] Where Age represents the graded assignment of the subject's age; TRE1' and TRE2' represent the graded assignment of different androgen response elasticity parameters, where β0, β1, β2 and β3 are fitting parameters for different terms, and e is the natural constant.

[0016] Optionally, in the module for calculating androgen response elasticity, the process of assigning graded values ​​to the androgen response elasticity parameter includes:

[0017] The androgen response elasticity parameter is classified into four levels. Based on the classification of different values ​​of the androgen response elasticity parameter, the classification results of the androgen response elasticity parameter are obtained according to the classification and assignment standard. The androgen response elasticity parameter includes the first androgen response elasticity parameter and the second androgen response elasticity parameter.

[0018] The grading and assignment standard for androgen response elasticity parameters is as follows:

[0019] When TRE1 < 0.5, TRE1' is 1; when TRE2 < 0.75, TRE2' is 1.

[0020] When 0.5 ≤ TRE1 < 1.0, TRE1' is 2; when 0.75 ≤ TRE2 < 1.50, TRE2' is 2.

[0021] When 1.0 ≤ TRE1 < 1.5, TRE1' is 3; when 1.50 ≤ TRE2 < 2.25, TRE2' is 3.

[0022] When 1.5≤TRE1, TRE1' is 4; when 2.25≤TRE2, TRE2' is 4.

[0023] Wherein, TRE1 and TRE2 are the first androgen response elasticity parameter and the second androgen response elasticity parameter, respectively, and TRE1' and TRE2' represent the graded assignment results corresponding to the androgen response elasticity parameters, respectively, the graded assignment results of the first androgen response elasticity parameter and the second androgen response elasticity parameter.

[0024] Optionally, in the module for calculating androgen response elasticity, the process of assigning age-based values ​​includes:

[0025] The subjects' ages were assigned a five-level grading system. Based on the subject age grading system, the subject age grading results were obtained.

[0026] The age grading criteria for test subjects are as follows:

[0027] Age is 0 when the subject is 30 years of age or younger;

[0028] Age is 1 when the subject is older than 30 but younger than 35;

[0029] Age is 2 when the subject is older than 35 years but younger than 40 years.

[0030] Age is 3 when the subject is older than 40 years but younger than 42 years;

[0031] When the subjects were 43 years of age or older, Age was 4;

[0032] Here, Age represents the subject's grade assignment.

[0033] Optionally, a prediction module is also included, wherein the prediction module is used to divide the probability of pregnancy by in vitro fertilization during ovarian stimulation into numerical intervals, and to predict the outcome of the long protocol intervention for ovulation induction based on the results of the numerical interval division.

[0034] Optionally, in the prediction module, the prediction process for the outcome of the long protocol intervention for ovulation induction includes:

[0035] When the probability of pregnancy through in vitro fertilization (p) is ≥ 80%, it is predicted that the subject has a superior outcome due to the long protocol intervention for ovulation induction.

[0036] When the probability of pregnancy through in vitro fertilization is 65% ≤ p < 80%, it is predicted that the subject has a good outcome with the long protocol of ovulation induction intervention.

[0037] When the probability of pregnancy through in vitro fertilization is 50% ≤ p < 65%, the subject is predicted to have a moderate outcome with the long protocol of ovulation induction intervention.

[0038] When the probability of pregnancy through in-vitro fertilization (p) is less than 50%, it is predicted that the subject belongs to the long protocol intervention with poor outcome.

[0039] Compared with the prior art, the present invention has the following advantages and technical effects:

[0040] The system provided by this invention offers high predictive accuracy and eliminates the need for subjective judgment by doctors. It does not have strict requirements regarding the method of serum testosterone detection, which helps doctors develop personalized intervention plans for subjects with normal AMH levels but lacking other test indicators, thus improving pregnancy outcomes after long-term ovulation induction protocols. Furthermore, the data collected by this system consists of routine, mandatory tests required in reproductive clinical institutions, excluding special or expensive examinations, facilitating wider adoption in more medical facilities. Attached Figure Description

[0041] The accompanying drawings, which form part of this application, are used to provide a further understanding of this application. The illustrative embodiments and descriptions of this application are used to explain this application and do not constitute an undue limitation of this application. In the drawings:

[0042] Figure 1 This is a schematic diagram of the system structure according to an embodiment of the present invention;

[0043] Figure 2 This diagram illustrates the accuracy evaluation results of in-vitro fertilization pregnancy outcomes based on different evaluation methods using different data, according to an embodiment of the present invention. Detailed Implementation

[0044] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other. This application will now be described in detail with reference to the accompanying drawings and embodiments.

[0045] It should be noted that the steps shown in the flowchart in the accompanying drawings can be executed in a computer system such as a set of computer-executable instructions, and although a logical order is shown in the flowchart, in some cases the steps shown or described may be executed in a different order than that shown here.

[0046] Given the limitations of existing technologies, particularly for subjects with normal anti-Müllerian hormone (AMH) levels, there is a lack of a system to assist in predicting and assessing the probability of pregnancy during in vitro fertilization (IVF) under ovarian stimulation. The system provided by this invention specifically relates to a system for assessing androgen response elasticity in subjects under a long ovulation induction protocol and the probability of pregnancy during IVF under ovarian stimulation. This system can be used to assess a subject's androgen response elasticity level to evaluate their ovarian fertility potential; and to predict the probability of pregnancy during IVF under ovarian stimulation to assess whether the subject's fertility potential has improved after appropriate androgen responsiveness treatment.

[0047] This invention first calculates the androgen response elasticity index based on the androgen levels of the subjects at different stages, and combines it with age to help predict the probability of pregnancy during ovarian stimulation in vitro fertilization (IVF). Then, based on the numerical range of the default IVF pregnancy probability stored in the system, it assists in predicting and evaluating the intervention outcome of the long protocol for ovulation induction in the subjects, so as to provide auxiliary suggestions for potential clinical intervention methods.

[0048] like Figure 1 As shown, specifically, the present invention includes the following:

[0049] The system for predicting and assessing the probability of pregnancy through in-vitro fertilization includes: a data acquisition module and a module for calculating androgen response elasticity.

[0050] The data acquisition module is used to obtain the subject's age and androgen levels at different stages. Androgen levels at different stages include the initial stage testosterone level (T0) in the venous serum of female subjects on any given day, and the serum testosterone level when the follicle diameter is 10–12 mm (T...). 10-12 Serum testosterone level on the day of HCG injection (T) HCG );

[0051] The androgen response elasticity (TRE) calculation module is used to calculate the above information obtained from the data acquisition module, thereby predicting the subject's androgen response elasticity (TRE) and the probability p of pregnancy during in vitro fertilization during ovarian stimulation.

[0052] It should be noted that the above-described system for assisting in the prediction and assessment of in vitro fertilization pregnancy probability is applicable to subjects with normal anti-Müllerian hormone (AMH) levels.

[0053] In the androgen response elasticity calculation module, androgen response elasticity is calculated based on androgen levels at different stages obtained from the data acquisition module. By combining androgen response elasticity and age, the probability of pregnancy p during ovarian stimulation is predicted. p is used to predict the outcome of long protocol intervention for ovulation induction.

[0054] In the module for calculating androgen response elasticity, data on the subject's age and androgen levels at different stages are graded and assigned values. The graded assignment results are then used to calculate the subject's probability of pregnancy through in-vitro fertilization, p.

[0055] In the module for calculating androgen response elasticity, the subject's age is not used directly in the calculation. Instead, the subject's age is assigned a five-level classification: subject's age ≤ 30, 30 < subject's age ≤ 35, 36 < subject's age ≤ 40, 40 < subject's age ≤ 42, and 42 ≤ subject's age.

[0056] Based on the five-level grading assignment for different subject ages, the grading assignment results for Age were redefined.

[0057] Age is 0 when the subject is 30 years of age or younger;

[0058] Age is 1 when the subject is older than 30 but younger than 35;

[0059] Age was 2 when the subject was older than 35 and younger than 40.

[0060] Age was 3 when the subject was older than 40 and younger than 42.

[0061] When the subjects were 43 years of age or older, Age was 4.

[0062] The module for calculating androgen response elasticity (TRE) pre-stores data on androgen levels at different stages of subjects from an existing multicenter database, as well as formulas for calculating TRE.

[0063] The formula is as follows: Formula 1:

[0064]

[0065] The formula is as follows: Formula 2:

[0066]

[0067] Wherein, TRE1 and TRE2 represent different calculated parameters used to characterize the androgen response elasticity of the subject, namely the first androgen response elasticity parameter and the second androgen response elasticity parameter, respectively, where T0 is the initial serum testosterone level, T... 10-12 Serum testosterone levels when follicle diameter is 10–12 mm, T HCG This data represents serum testosterone levels on the day of HCG injection. Testosterone levels are expressed in ng / mL and need to be converted to the units used in clinical laboratory testing.

[0068] In the module for calculating androgen response elasticity, the subject's androgen response elasticity is not directly used to calculate the probability of IVF pregnancy. Instead, the androgen response elasticity parameter is assigned a four-level grading. Specifically, for the androgen response elasticity parameter at different numerical levels of the four-level grading, the corresponding grading results TRE1' and TRE2' of the androgen response elasticity parameter are redefined.

[0069] When the calculated first androgen response elasticity parameter TRE1 < 0.5, TRE1' is 1; when TRE2 < 0.75, TRE2' is 1.

[0070] When the calculated androgen response elasticity is 0.5≤TRE1<1.0, TRE1' is 2; when it is 0.75≤TRE2<1.50, TRE2' is 2.

[0071] When the calculated androgen response elasticity is 1.0≤TRE1<1.5, TRE1' is 3; when it is 1.50≤TRE2<2.25, TRE2' is 3.

[0072] When the calculated androgen response elasticity is 1.5≤TRE1, TRE1' is 4; when it is 2.25≤TRE2, TRE2' is 4.

[0073] Based on the above-mentioned converted parameters, this invention provides a method for predicting the pregnancy probability p of in vitro fertilization (IVF) during ovarian stimulation in subjects under a long protocol of assisted reproductive ovulation induction. The pregnancy probability p is used to assess whether the fertility potential of subjects has improved after corresponding androgen response treatment.

[0074] In the module for calculating androgen response elasticity, a formula for predicting the probability of pregnancy through in vitro fertilization for a subject is pre-stored, which is fitted based on the subject's age in an existing multicenter database and the calculated androgen response elasticity (TRE) grading results.

[0075] The formula is as follows: Formula 3:

[0076]

[0077] Where p is the calculated value used to characterize the probability of pregnancy during ovarian stimulation in vitro fertilization (IVF); Age is the graded assignment result of the subject's age; TRE1' and TRE2' are the graded assignment results of the first androgen response elasticity parameter and the second androgen response elasticity parameter, respectively, where β0, β1, β2 and β3 are fitting parameters for different terms;

[0078] The fitted parameters for the correlation between the graded assignment results and the probability of pregnancy are as follows:

[0079] The value space of β0 is [-0.889, 1.544]; the value space of β1 is [-1.498, -0.456]; the value space of β2 is [0.152, 1.799]; and the value space of β3 is [-0.947, 0.154].

[0080] The formula for predicting the probability of pregnancy through in vitro fertilization for a subject, which is fitted with pre-stored graded values ​​based on subject data from an existing multi-center database, has the following values: β0 = 0.4311; β1 = -0.8956; β2 = 0.7938; β3 = -0.2938.

[0081] The system for assisting in predicting and assessing the probability of pregnancy through in vitro fertilization according to the present invention further includes a prediction module. The prediction module has a default numerical range of the probability of pregnancy through in vitro fertilization pre-stored in the module. Based on the numerical range, the calculated probability of pregnancy through in vitro fertilization p is divided into numerical ranges or defined, thereby predicting the outcome of long protocol intervention for ovulation induction.

[0082] Within the pre-stored numerical range in the prediction module, the predicted outcome of the long-term ovulation induction protocol intervention is output according to the following criteria:

[0083] When the calculated probability of pregnancy through in vitro fertilization for a subject is p≥80%, the prediction module determines that the subject has a superior outcome for the long protocol intervention for ovulation induction.

[0084] When the calculated probability of pregnancy through in vitro fertilization for a subject is 65% ≤ p < 80%, the prediction module determines that the subject has a good outcome from the long protocol intervention for ovulation induction.

[0085] When the calculated probability of pregnancy through in vitro fertilization for a subject is 50% ≤ p < 65%, the prediction module determines that the subject belongs to the intermediate outcome of the long protocol intervention for ovulation induction.

[0086] When the calculated probability of pregnancy through in vitro fertilization for a subject is p < 50%, the prediction module determines that the subject belongs to the category of poor outcome of long protocol intervention for ovulation induction.

[0087] Experimental example:

[0088] Experimental Example 1

[0089] 1. General Information: Data from 109 participants treated at the Reproductive Center of Guangdong Provincial People's Hospital (Guangdong Provincial Hospital Reproductive Center) between January 2021 and December 2023 were collected for this study. Women included in this study met the following criteria: infertility; age 20-40 years; body mass index (BMI) 18-26 kg / m². 2 Serum anti-Müllerian hormone (AMH) > 1.1 ng / mL; regular natural menstrual cycles (21-35 days); fresh embryo transfer in an IVF (in vitro fertilization) and ICSI (intracytoplasmic sperm injection) cycle using the GnRH-a long protocol after controlled ovarian stimulation (COS) monitoring; and the first or second IVF and ICSI cycle. Patients with any of the following were excluded: polycystic ovary syndrome or other hyperandrogen-related disorders (such as adrenal hyperplasia, gonadal abnormalities, and pituitary lesions) and hyperprolactinemia; chromosomal abnormalities; stage III-IV endometriosis or adenomyosis; hydronephrosis confirmed by ultrasound; or endocrine disorders such as diabetes and thyroid dysfunction.

[0090] 2. Data collection: The following information was collected from the electronic medical records of the Provincial Hospital Reproductive Center: (1) General information: female age, anti-Müllerian hormone (AMH) level of the subject, serum testosterone level in the initial stage (T0), serum testosterone level when the follicle diameter was 10-12 mm (T0). 10-12 Serum testosterone levels (T) on the day of HCG injection HCG Data such as ).

[0091] 3. Data Analysis: This study used serum testosterone levels at different stages to calculate a new index of androgen response elasticity. Female age was re-assigned a five-level gradation. Serum testosterone and AMH were continuous variables. The calculated androgen response elasticity parameter was assigned a four-level gradation. The predicted probability of pregnancy through in-vitro fertilization (p) was a continuous variable, and the pregnancy outcome after long-protocol ovulation induction was represented by the predictive merit across four numerical intervals. Pregnancy outcomes used for model construction and validation included both success and failure.

[0092] 4. Research Results

[0093] 4.1 Provide relevant clinical and biochemical data of subjects under the long ovulation induction protocol, as shown in Table 1.

[0094] Table 1

[0095] Data from the Provincial Hospital over the past three years (n=109) Average age (years) 31.4±3.8 AMH (ng / mL) 3.02±1.59 <![CDATA[T0]]> 1.30±0.58 <![CDATA[T 10-12 ]]> 1.51±0.69 <![CDATA[T HCG ]]> 2.27±0.95

[0096] 4.2 Calculation of androgen response elasticity

[0097] In this experimental example, the androgen response elasticities TRE1 and TRE2 of the above 109 subjects were calculated according to Formula 1 and Formula 2 respectively, and were re-assigned according to the fourth-order androgen response elasticity parameter grading and assignment standard, which were used to calculate the in vitro fertilization pregnancy probability p of the subjects.

[0098] 4.3 Fitting calculation of the in vitro fertilization pregnancy probability p of the subjects

[0099] In this embodiment, the age and androgen response elasticity (TRE) values ​​of 109 subjects were reclassified and re-scored. Combined with pre-stored data from an existing multi-center database and pregnancy outcomes, a value was fitted to calculate the probability of pregnancy during in vitro fertilization (IVF) under ovarian stimulation. The fitted parameters obtained in the correlation between the grading results and the pregnancy probability are as follows:

[0100] The value space of β0 is [-0.889, 1.544]; the value space of β1 is [-1.498, -0.456]; the value space of β2 is [0.152, 1.799]; and the value space of β3 is [-0.947, 0.154].

[0101] In this embodiment, the values ​​of the parameters in the fitted formula used to predict the probability of pregnancy p of the subject through in vitro fertilization are: β0 = 0.4311; β1 = -0.8956; β2 = 0.7938; β3 = -0.2938.

[0102] 4.4 Predicting the long protocol intervention outcome for ovulation induction in 109 subjects, the results are shown in Table 2.

[0103] Table 2

[0104]

[0105]

[0106] 4.5 The androgen response elasticity and the accuracy of AMH assessment of in vitro fertilization pregnancy outcomes in subjects were compared. The results are shown in Table 3.

[0107] Table 3

[0108] category AUC (95% CI) AUPRC (95% CI) Age+AMH 0.58(0.41±0.75) 0.72(0.55±0.88) TRE1+TRE2 0.73(0.55±0.90) 0.71(0.55±0.93) Age+TRE1+TRE2 0.83(0.66±0.92) 0.87(0.75±0.95)

[0109] Combination such as Figure 2 The results shown illustrate the accuracy evaluation of in-vitro fertilization pregnancy outcomes using different assessment methods based on different data. Figure 2 In the middle, A represents the accuracy assessment results of Age and AMH in evaluating the in-vitro fertilization pregnancy outcomes of the subjects. Figure 2 In this context, B represents the accuracy of the androgen response elasticity indices TRE1 and TRE2 in assessing the pregnancy outcomes of subjects undergoing in vitro fertilization. Figure 2 In the figure, C represents the accuracy of Age and androgen response elasticity indices TRE1 and TRE2 in assessing the pregnancy outcome of subjects through in vitro fertilization. The above evaluation results are evaluated by receiver operating characteristic (ROC) curves, where the solid line represents the corresponding ROC curve, the dashed line corresponds to 50% accuracy, and the AUC is the area under the curve.

[0110] The above results indicate that, compared with the traditional methods of using AMH and age as predictors of pregnancy outcomes in in-vitro fertilization (IVF), androgen response elasticity and age are more suitable for predicting IVF pregnancy outcomes.

[0111] Experimental Example 2

[0112] 1. General Information: Data collected from June 2022 to June 2024 at the First Affiliated Hospital of Sun Yat-sen University, the Second Affiliated Hospital of Sun Yat-sen University, and the Huifu Branch of Guangdong Provincial People's Hospital.

[0113] Data from 151 participants were used in the study. Women included in this study met the following criteria: infertility; age 20-40 years; body mass index (BMI) 18-26 kg / m². 2Serum anti-Müllerian hormone (AMH) > 1.1 ng / mL; regular natural menstrual cycles (21-35 days); fresh embryo transfer in an IVF (in vitro fertilization) and ICSI (intracytoplasmic sperm injection) cycle using the GnRH-a long protocol after controlled ovarian stimulation (COS) monitoring; and the first or second IVF and ICSI cycle. Patients with any of the following were excluded: polycystic ovary syndrome or other hyperandrogen-related disorders (such as adrenal hyperplasia, gonadal abnormalities, and pituitary lesions) and hyperprolactinemia; chromosomal abnormalities; stage III-IV endometriosis or adenomyosis; hydronephrosis confirmed by ultrasound; or endocrine disorders such as diabetes and thyroid dysfunction.

[0114] 2. Data collection: The following information was collected from the electronic medical records of the Provincial Hospital Reproductive Center: (1) General information: female age, anti-Müllerian hormone (AMH) level of the subject, serum testosterone level (T0) in the initial stage, and serum testosterone level (T0) when the follicle diameter was 10-12 mm. 10-12 Serum testosterone levels (T) on the day of HCG injection HCG Data such as ).

[0115] 3. Data Analysis: This study used serum testosterone levels at different stages to calculate a new androgen response elasticity index. Female age was reclassified into a five-tiered scale. Serum testosterone and AMH were continuous variables. The calculated androgen response elasticity index was then classified into a four-tiered scale. The predicted probability of pregnancy through in-vitro fertilization (p) was a continuous variable, and pregnancy outcomes after long-protocol ovulation induction were evaluated using a four-tiered scale. Pregnancy outcomes used for model construction and validation included both success and failure.

[0116] 4. Research Results

[0117] 4.1. Provide clinical and biochemical data of subjects under the long ovulation induction protocol, as shown in Table 4.

[0118] Table 4

[0119] Multicenter data from 2022-2024 (n=151) Average age (years) 33.4±4.0 AMH (ng / mL) 2.92±1.56 <![CDATA[T0]]> 1.25±0.56 <![CDATA[T 10-12 ]]> 1.45±0.67 <![CDATA[T HCG ]]> 2.19±0.92

[0120] 4.2 Predicted the long protocol intervention outcome for ovulation induction in 151 subjects. The results are shown in Table 5.

[0121] Table 5

[0122]

[0123]

[0124] Experimental Example 3

[0125] 1. General Information: Data from 44 participants (28 cases of secondary infertility and 16 cases of primary infertility) in the intervention study conducted by the inventor's team at Guangdong Provincial People's Hospital from January 2023 to December 2023 were selected for this study. Women included in this study met the following criteria: infertility; age 20-40 years; body mass index (BMI) 18-26 kg / m². 2 Serum anti-Müllerian hormone (AMH) > 1.1 ng / mL; regular natural menstrual cycles (21-35 days); fresh embryo transfer in an IVF (in vitro fertilization) and ICSI (intracytoplasmic sperm injection) cycle using the GnRH-a long protocol after controlled ovarian stimulation (COS) monitoring; and the first or second IVF and ICSI cycle. Patients with any of the following were excluded: polycystic ovary syndrome or other hyperandrogen-related disorders (such as adrenal hyperplasia, gonadal abnormalities, and pituitary lesions) and hyperprolactinemia; chromosomal abnormalities; stage III-IV endometriosis or adenomyosis; hydronephrosis confirmed by ultrasound; or endocrine disorders such as diabetes and thyroid dysfunction.

[0126] 2. Data collection: The following information was collected from the electronic medical records of the Provincial Hospital Reproductive Center: (1) General information: female age, anti-Müllerian hormone (AMH) level of the subject, serum testosterone level (T0) in the initial stage, and serum testosterone level (T0) when the follicle diameter was 10-12 mm. 10-12 Serum testosterone levels (T) on the day of HCG injection HCG Data such as ).

[0127] 3. Data Analysis: This study used serum testosterone levels at different stages to calculate a new index of androgen response elasticity. Female age was re-assigned a five-level gradation. Serum testosterone and AMH were continuous variables. The calculated androgen response elasticity parameter was assigned a four-level gradation. The predicted probability of pregnancy through in-vitro fertilization (p) was a continuous variable, and the pregnancy outcome after long-protocol ovulation induction was represented by the predictive merit across four numerical intervals. Pregnancy outcomes used for model construction and validation included both success and failure.

[0128] 4. Research Results

[0129] 4.1 Calculation of androgen response elasticity

[0130] In this embodiment, the androgen response elasticities TRE1 and TRE2 of the above 44 subjects were calculated according to Formula 1 and Formula 2 respectively, and converted according to the four-level grading standard for use in calculating the in vitro fertilization pregnancy probability p of the subjects.

[0131] 4.2 Fitting calculation of the in vitro fertilization pregnancy probability p of the subjects

[0132] In this embodiment, the formula parameters used to predict the probability p of pregnancy through in vitro fertilization for the subject are: β0 = 0.4311; β1 = -0.8956; β2 = 0.7938; β3 = -0.2938.

[0133] 4.3. Provide clinical and biochemical data of subjects under the long ovulation induction protocol, as shown in Table 6.

[0134] Table 6

[0135] Secondary infertility (n=28) Primary infertility (n=16) Average age (years) 33.1±4.1 33.9±3.8 <![CDATA[T0]]> 0.35±0.14 0.48±0.15 <![CDATA[T 10-12 ]]> 0.48±0.21 0.54±0.20 <![CDATA[T HCG ]]> 0.68±0.27 0.71±0.25

[0136] 4.4 Predicting the long protocol intervention outcome for 44 subjects, the results are shown in Table 7.

[0137] Table 7

[0138] category Predicting the success rate of intervention outcomes Secondary infertility (n=28) 56.6% Primary infertility (n=16) 100%

[0139] The above are merely preferred embodiments of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A system for assisted prediction of the probability of pregnancy in in vitro fertilization based on the androgenic response elasticity, characterized by, The system comprises: a data collection module and a calculation module of androgen response elasticity; the data collection module is configured to collect the age of a subject and androgen levels at different stages; and the calculation module of androgen response elasticity is configured to calculate androgen response elasticity parameters according to the collected androgen levels at different stages, and obtain a probability of in vitro fertilization pregnancy during ovarian stimulation according to the androgen response elasticity parameters and the age of the subject; in the data collection module, the androgen levels at different stages include a testosterone level at an initial stage, a serum testosterone level when a follicle diameter is 10-12 mm, and a serum testosterone level on a day of HCG injection; in the calculation module of androgen response elasticity, the androgen response elasticity parameters are obtained through the following process: wherein TRE1 and TRE2 represent different parameters for characterizing the androgen response elasticity of the subject, respectively a first androgen response elasticity parameter and a second androgen response elasticity parameter, wherein T0 is the serum testosterone level at the initial stage, T 10-12 is the serum testosterone level at the follicle diameter of 10-12 mm, T HCG is the data of the serum testosterone level on the day of HCG injection; in the calculation module of androgen response elasticity, the probability of in vitro fertilization pregnancy during ovarian stimulation is obtained according to the androgen response elasticity parameters and the age of the subject, wherein the androgen response elasticity and the age of the subject are classified and assigned, and the probability of in vitro fertilization pregnancy during ovarian stimulation is calculated according to the classified and assigned results corresponding to the androgen response elasticity and the age; in the calculation module of androgen response elasticity, the probability p of in vitro fertilization pregnancy during ovarian stimulation is calculated through the following process: wherein Age is the classified and assigned result of the age of the subject; TRE1' and TRE2' are the classified and assigned results of different androgen response elasticity parameters, wherein β0, β1, β2 and β3 are fitting parameters of different terms, and e is a natural constant.

2. The system according to claim 1, wherein in the calculation module of androgen response elasticity, the process of classifying and assigning the androgen response elasticity parameters comprises: the androgen response elasticity parameters are classified and assigned in four stages, and the classified and assigned results of the androgen response elasticity parameters are obtained according to the classification and assignment standards of the androgen response elasticity parameters, wherein the androgen response elasticity parameters include a first androgen response elasticity parameter and a second androgen response elasticity parameter; the classification and assignment standards of the androgen response elasticity parameters are as follows: when TRE1 < 0.5, TRE1' is 1; and when TRE2 < 0.75, TRE2' is 1; when 0.5 ≤ TRE1 < 1.0, TRE1' is 2; and when 0.75 ≤ TRE2 < 1.50, TRE2' is 2; when 1.0 ≤ TRE1 < 1.5, TRE1' is 3; and when 1.50 ≤ TRE2 < 2.25, TRE2' is 3; when 1.5 ≤ TRE1, TRE1' is 4; and when 2.25 ≤ TRE2, TRE2' is 4; wherein TRE1 and TRE2 are the first androgen response elasticity parameter and the second androgen response elasticity parameter, respectively, and TRE1' and TRE2' represent the classified and assigned results of the androgen response elasticity parameters, which are the classified and assigned results of the first androgen response elasticity parameter and the second androgen response elasticity parameter, respectively.

3. The system according to claim 1, wherein in the calculation module of androgen response elasticity, the process of classifying and assigning the age comprises: The subject age is classified into five levels, and the subject age is classified according to the subject age classification standard, and the classification result of the subject age is obtained; The subject age classification standard is: When the subject age is 30 years old or below, Age is 0; When the subject age is greater than 30 years old and 35 years old or below, Age is 1; When the subject age is greater than 35 years old and 40 years old or below, Age is 2; When the subject age is greater than 40 years old and 42 years old or below, Age is 3; When the subject age is 43 years old or above, Age is 4; Wherein, Age is the classification result of the subject.

4. The system of claim 1, further comprising a prediction module configured to divide the probability of in vitro fertilization pregnancy during ovarian stimulation into a numerical interval, and predict the intervention outcome of the long protocol of controlled ovarian hyperstimulation according to the numerical interval division result.

5. The system of claim 1, wherein the prediction process of the intervention outcome of the long protocol of controlled ovarian hyperstimulation in the prediction module comprises: When the probability of in vitro fertilization pregnancy p is greater than or equal to 80%, it is predicted that the subject belongs to the good intervention outcome of the long protocol of controlled ovarian hyperstimulation; When the probability of in vitro fertilization pregnancy 65%≤p<80%, it is predicted that the subject belongs to the good intervention outcome of the long protocol of controlled ovarian hyperstimulation; When the probability of in vitro fertilization pregnancy 50%≤p<65%, it is predicted that the subject belongs to the medium intervention outcome of the long protocol of controlled ovarian hyperstimulation; When the probability of in vitro fertilization pregnancy p is less than 50%, it is predicted that the subject belongs to the poor intervention outcome of the long protocol of controlled ovarian hyperstimulation. ​ ​

Citation Information

Patent Citations

  • Method for constructing prediction model of ovarian hypofunction population IVF / ICSI pregnancy-assisting outcome based on ovarian sensitivity index

    CN118692670A