The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer: a Prospective Blinded Multicentre Cohort Study

Last updated: October 14, 2024
Sponsor: Fundación IVI
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06643065
2403-JUN-096-KS
  • Ages 18-50
  • Female

Study Summary

Microorganisms such as bacteria live naturally on and in the bodies and are of great importance for our health. In the female body, almost 10% of all microorganisms live in the reproductive organs and especially in the vagina. Healthy bacteria in the vagina can defend against harmful bacteria and infections. However, it occasionally happens that the balance between healthy and harmful bacteria is disturbed, and it is believed that this could potentially harm pregnancy. However, there is not much evidence to prove a connection between an imbalance in bacteria and having an unsuccessful pregnancy.

For this reason, the goal of our study is to determine if women with certain vaginal bacteria are more likely to experience pregnancy failures. If the investigators find this to be true, patients undergoing fertility treatment might be recommended regular tests in the future. If an imbalance in bacteria is found, doctors could provide treatment to restore a healthy vaginal environment, potentially improving the chances of a successful pregnancy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ART patients undergoing the transfer of a euploid embryo

Exclusion

Exclusion Criteria:

  • Patients with a body mass index (BMI) ≥35

  • Patients with uncorrected uterine malformations

  • Patients with a unicornuate uterus

  • Patients with a bicornuate uterus

  • Patients with any type of submucosal myoma

  • Patients with an intramural myoma if ≥4 cm

  • Patients with severe adenomyosis (>50% of the uterine corpus affected asdefined by the MUSA criteria [19])

  • Patients undergoing transfer of an embryo with a morphology score <4BC (according to the Gardner & Schoolcraft scoring system [18])

  • Patients undergoing transfer of a day-7 embryo

  • Patients who took antibiotics in the month prior to the embryo transfer (excluding antibiotics given following oocyte retrieval)

Study Design

Total Participants: 1573
Study Start date:
July 17, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Ginefiv Barcelona

    Barcelona, 08015
    Spain

    Active - Recruiting

  • IVI Barcelona

    Barcelona, 08029
    Spain

    Active - Recruiting

  • IVI Bilbao

    Bilbao, 48940
    Spain

    Active - Recruiting

  • Ginefiv Madrid

    Madrid, 28043
    Spain

    Active - Recruiting

  • IVI Madrid

    Madrid, 28023
    Spain

    Active - Recruiting

  • IVI Málaga

    Málaga, 29006
    Spain

    Active - Recruiting

  • Ginemed Sevilla

    Sevilla, 41010
    Spain

    Active - Recruiting

  • IVI Valencia

    Valencia, 46015
    Spain

    Active - Recruiting

  • IVI Vigo

    Vigo, 36203
    Spain

    Active - Recruiting

  • IVI Zaragoza

    Zaragoza, 50018
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.