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

NCT04820985 | Completed

• 1 other identifier: NIMAO/2020-01/SH-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

IVF

Keywords

Pregnancy; vaginal microbiota; Progesterone

Outcome Measures

Primary Outcomes (5)

• Class of vaginal flora according to community state type

  Classified into 5 classes of vaginal flora described according to Smith \& Ravel 2017

  3 Months before ovarian stimulation

• Microbiota richness of vaginal flora

  Measured by operational taxonomic unit

  3 Months before ovarian stimulation

• Microbiota alpha diversity of vaginal flora

  Shannon Index

  3 Months before ovarian stimulation

• Microbiota beta diversity of vaginal flora

  Bray Curtis index

  3 Months before ovarian stimulation

• Plasma progesterone level on the day of embryo transfer

  Measured by chemiluminescence (nmol/L)

  Day of embryo transfer (Day 0)

Secondary Outcomes (16)

• Class of vaginal flora according to community state type

  Day of oocyte puncture (Month 3)

• Class of vaginal flora according to community state type

  Day of embryo transfer (Day 93)

• Class of vaginal flora according to community state type

  Day of beta-human chorionic gonadotropin dosage (Day 108)

• Microbiota richness of vaginal flora

  Day of oocyte puncture (Month 3)

• Microbiota richness of vaginal flora

  Day of embryo transfer (Day 93)

Study Arms (1)

Women undergoing IVF

Other: Vaginal swab; Other: Blood test

Interventions

Vaginal swab OTHER

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

Women undergoing IVF

Blood test OTHER

Blood sample to measure plasma dose of progesterone

Women undergoing IVF

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 to 40 inclusive, Round1 or 2 of IVF or IVF-ICSI with fresh embryo transfer, without taking antibiotics in the 3 months preceding the first sample treated in the AMP center of the CHU de Nîmes.

You may qualify if:

• 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

You may not qualify if:

• 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 refuses to sign the consent
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, 30029, France

Location

Related Publications (1)

• Smith SB, Ravel J. The vaginal microbiota, host defence and reproductive physiology. J Physiol. 2017 Jan 15;595(2):451-463. doi: 10.1113/JP271694. Epub 2016 May 5.

  PMID: 27373840 BACKGROUND

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Stéphanie Huberlant

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: May 26, 2021
• Primary Completion: January 11, 2023
• Study Completion: April 22, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

FR (1)