Lactobacillus Colonization for IVF Success

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Solution Overview

Problem

Women of childbearing age with abnormal vaginal microbiota, particularly bacterial vaginosis, face challenges in IVF success due to abnormal vaginal flora, which can lead to increased risks of infections, preterm delivery, and reduced fertility, as current diagnostic and treatment methods are inadequate in addressing asymptomatic cases and improving IVF outcomes.

Innovation Solution

A method involving the administration of antibiotics to reduce abnormal vaginal microbiota followed by the introduction of high potency Lactobacillus species, specifically Lactobacillus crispatus, Lactobacillus jensenii, or Lactobacillus gasseri, to colonize the vaginal mucosa, thereby improving the success rate of in vitro fertilization by restoring a healthy vaginal microbiota.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If antibiotics are administered to treat bacterial vaginosis, then abnormal vaginal microbiota is reduced, but the vaginal environment becomes less stable and more susceptible to infection

Engineering Contradiction:
Improveabnormal vaginal microbiotaVSAvoidvaginal environment stability
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent applies preliminary action by administering antibiotics before IVF treatment to eliminate abnormal vaginal microbiota, then immediately following with Lactobacillus administration to restore protective flora before the embryo transfer procedure, ensuring the vaginal environment is optimized in advance

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses Lactobacillus species as an intermediary organism that mediates between the harmful abnormal microbiota and the vaginal environment. These beneficial bacteria produce lactic acid and hydrogen peroxide that actively suppress pathogens while restoring ecological balance

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If Lactobacillus species are administered to colonize vaginal mucosa, then protective biofilm is enhanced, but the complexity of treatment protocol increases

Engineering Contradiction:
Improveprotective biofilmVSAvoidtreatment protocol
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies parameter changes by specifying precise dosing regimens (e.g., 10^8 to 10^10 CFU per dose), administration frequencies (daily, twice weekly), and treatment durations (7 days before embryo transfer, continuing through pregnancy) to optimize Lactobacillus colonization while managing protocol complexity

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If vaginal microbiota is monitored to diagnose bacterial vaginosis, then treatment accuracy is improved, but asymptomatic cases are missed and IVF success rate remains reduced

Engineering Contradiction:
ImproveBV diagnosis accuracyVSAvoidIVF success rate
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The patent applies preliminary action by administering Lactobacillus species to all women before IVF embryo transfer regardless of BV diagnosis status. This proactive approach ensures protective flora is established in advance, addressing both symptomatic and asymptomatic cases and optimizing vaginal environment for implantation

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent empowers the vaginal microbiota to self-regulate by introducing Lactobacillus species that naturally produce antimicrobial substances (lactic acid, hydrogen peroxide) and compete with pathogens for resources, creating a self-sustaining protective ecosystem

Inventive Principle:
Principle #25Self-service

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The treatment effectively reduces abnormal vaginal microbiota and enhances the colonization of protective Lactobacillus species, improving IVF success rates by creating a favorable vaginal environment, reducing infection risks, and promoting fertility.

Implementation Method 1

These facultative anaerobes metabolize glucose to lactic acid, contributing to the maintenance of a low vaginal pH (4.0-4.5)

Methodology Applied
Scientific EffectFermentation: Fermentation

Implementation Method 2

L. crispatus, L. jensenii, and L. gasseri are capable of producing H2O2

Methodology Applied
Scientific EffectHydrogen peroxide production: Hydrogen Peroxide

Data Source

PatentUS11278581B2Use of vaginal <i>Lactobacilli </i>for improving the success rate of in vitro fertilization
Publication Date: 2022.03.22 OSEL INC
  • US11278581B2 patent drawing
  • US11278581B2 patent drawing
  • US11278581B2 patent drawing

AI summary

This invention provides for a method for improving the success rate of in vitro fertilization in women hosting abnormal vaginal microbiota. The method comprises the steps of: (i) selecting a woman suspected of hosting abnormal vaginal microbiota (AVM); (ii) administering to the woman a suitable antibiotic administered in an amount and duration effective to reduce the quantity of abnormal vaginal microbiota hosted by the woman; (iii) administering to the woman via vaginal administration an amount of Lactobacillus species in an amount sufficient to colonize the vaginal mucosa; and, (iv) transferring an embryo to the woman.