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Analysis of the Composition of the Vaginal Microbiota During IVF Treatment and Correlation With Serum Progesterone Level on the Day of Embryo Transfer

Analyse de la Composition du Microbiote Vaginal à différents Temps de la Prise en Charge en FIV et corrélation Avec le Taux de progestérone sérique le Jour du Transfert d'Embryon

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04820985
Acronym
MICROFIV
Enrollment
60
Registered
2021-03-29
Start date
2021-05-26
Completion date
2024-04-22
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IVF

Keywords

Pregnancy, vaginal microbiota, Progesterone

Brief summary

The composition of the vaginal microbiota varies throughout a woman's life and is sensitive to hormonal and environmental factors. Specifically, hormonal treatments necessary in the medically assisted procreation (MAP) processes can influence the vaginal microbiota. New sequencing techniques have been used to characterize the vaginal microbiota, demonstrating that the microbiota could be divided into 5 classes. The composition of the vaginal microbiota seems to have an implication in the evolution of a pregnancy after IVF. It is therefore essential to have more data on the evolution of the vaginal microbiota at the different stages of IVF treatment and to analyze whether this evolution can be predictive of the success of embryo implantation. Good endometrial progesterone impregnation is an essential prerequisite for ensuring embryo implantation. Indeed, supporting the luteal phase through vaginal progesterone is an essential step in IVF protocols to ensure synchronization between endometrial maturation and embryonic age. However, the serum progesterone level on the day of embryo transfer varies widely between patients. Several factors such as age, vaginal mucosa trophicity, estrogen impregnation and sexual activity are known to affect the vaginal absorption of progesterone. The treatments and vaginal examinations performed during the IVF procedure could also have an impact on the constitution of the vaginal microbiota. The hypothesis of this research is that there is an alteration in the vaginal microbiota during the IVF process which may alter the absorption of vaginal progesterone, with an impact on the failure or success of embryo implantation.

Interventions

Vaginal flora swab 3 months before stimulation, at oocyte puncture, embryo transfer and beta-human chorionic gonadotropin dosing

OTHERBlood test

Blood sample to measure plasma dose of progesterone

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years

Inclusion criteria

* Patient in round 1 or 2 of IVF or IVF-ICSI with transfer of a fresh embryo with a normal preimplantation assessment, without antibiotic treatment in the 3 months preceding the sample. * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan

Exclusion criteria

* Use of antibiotics in the 3 months preceding the sample. * Patient presenting an anomaly in the implantation assessment. * Presence of uterine malformation, hydrosalpinx, chronic vaginosis. * Patient undergoing a protocol to study endometrial receptivity. * Patient of African American, African or Latin American origin (patients born to two parents of Hispanic origin) as people of African and Hispanic origin have a type IV flora vs people of Caucasian origins who have type I, II, III and V of the Ravel classification . * Cancellation of the procedure for various reasons (stimulation failure, collection failure, fertilization failure or embryonic segmentation). * Patient taking a freeze-all approach (freezing of the embryos) for various causes (risk of ovarian hyperstimulation, increase in progesterone, too thin endometrium, etc.). * The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study * The subject refuses to sign the consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship

Design outcomes

Primary

MeasureTime frameDescription
Microbiota beta diversity of vaginal flora3 Months before ovarian stimulationBray Curtis index
Class of vaginal flora according to community state type3 Months before ovarian stimulationClassified into 5 classes of vaginal flora described according to Smith & Ravel 2017
Microbiota richness of vaginal flora3 Months before ovarian stimulationMeasured by operational taxonomic unit
Microbiota alpha diversity of vaginal flora3 Months before ovarian stimulationShannon Index
Plasma progesterone level on the day of embryo transferDay of embryo transfer (Day 0)Measured by chemiluminescence (nmol/L)

Secondary

MeasureTime frameDescription
Pregnancy progressionMonth 3Implantation failure/progression/miscarriage
Class of vaginal flora according to community state typeDay of oocyte puncture (Month 3)Classified into 5 classes of vaginal flora described according to Smith & Ravel 2017
Plasma progesterone levelMonth 3Measured by chemiluminescence (nmol/L)
Treatments received for IVFMonth 3Description of treatments, taken from patient file
Microbiota richness of vaginal floraDay of oocyte puncture (Month 3)Measured by operational taxonomic unit
Microbiota alpha diversity of vaginal floraDay of oocyte puncture (Month 3)Shannon Index
Microbiota beta diversity of vaginal floraDay of oocyte puncture (Month 3)Bray Curtis index
Pregnancy successMonth 3Yes/No

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026