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Completed

NCT Number: NCT04820985

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

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.

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Key information

Conditions

IVF

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Nimes

Nîmes, 30029, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vaginal swab

Other

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

Blood Test

Other

Blood sample to measure plasma dose of progesterone

Primary outcomes

  1. Class of vaginal flora according to community state type

    Time frame: 3 Months before ovarian stimulation

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

  2. Microbiota richness of vaginal flora

    Time frame: 3 Months before ovarian stimulation

    Measured by operational taxonomic unit

  3. Microbiota alpha diversity of vaginal flora

    Time frame: 3 Months before ovarian stimulation

    Shannon Index

  4. Microbiota beta diversity of vaginal flora

    Time frame: 3 Months before ovarian stimulation

    Bray Curtis index

  5. Plasma progesterone level on the day of embryo transfer

    Time frame: Day of embryo transfer (Day 0)

    Measured by chemiluminescence (nmol/L)

Secondary outcomes

  1. Class of vaginal flora according to community state type

    Time frame: Day of oocyte puncture (Month 3)

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

  2. Class of vaginal flora according to community state type

    Time frame: Day of embryo transfer (Day 93)

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

  3. Class of vaginal flora according to community state type

    Time frame: Day of beta-human chorionic gonadotropin dosage (Day 108)

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

  4. Microbiota richness of vaginal flora

    Time frame: Day of oocyte puncture (Month 3)

    Measured by operational taxonomic unit

  5. Microbiota richness of vaginal flora

    Time frame: Day of embryo transfer (Day 93)

    Measured by operational taxonomic unit

  6. Microbiota richness of vaginal flora

    Time frame: Day of beta-human chorionic gonadotropin dosage (Day 108)

    Measured by operational taxonomic unit

  7. Microbiota alpha diversity of vaginal flora

    Time frame: Day of oocyte puncture (Month 3)

    Shannon Index

  8. Microbiota alpha diversity of vaginal flora

    Time frame: Day of embryo transfer (Day 93)

    Shannon Index

  9. Microbiota alpha diversity of vaginal flora

    Time frame: Day of beta-human chorionic gonadotropin dosage (Day 108)

    Shannon Index

  10. Microbiota beta diversity of vaginal flora

    Time frame: Day of oocyte puncture (Month 3)

    Bray Curtis index

  11. Microbiota beta diversity of vaginal flora

    Time frame: Day of embryo transfer (Day 93)

    Bray Curtis index

  12. Microbiota beta diversity of vaginal flora

    Time frame: Day of beta-human chorionic gonadotropin dosage (Day 108)

    Bray Curtis index

  13. Pregnancy success

    Time frame: Month 3

    Yes/No

  14. Pregnancy progression

    Time frame: Month 3

    Implantation failure/progression/miscarriage

  15. Treatments received for IVF

    Time frame: Month 3

    Description of treatments, taken from patient file

  16. Plasma progesterone level

    Time frame: Month 3

    Measured by chemiluminescence (nmol/L)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: MICROFIV

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Mar 29, 2021
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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