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

Recruiting

• Conditions: Vaginal Microbiome

• Registration Number: NCT06643065
• Lead Sponsor: Fundación IVI

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-17
• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-15
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1573

Inclusion Criteria

• ART patients undergoing the transfer of a euploid embryo

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 as defined 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
microbial DNA extraction using molecular techniques such as qPCR	day of embryo transfer (between days 18 and 21 of the menstrual cycle)	microbial composition. Detection (i.e., presence or absence) of the targeted bacteria and their quantification (i.e., the relative amount of each bacterial species present in the sample).

Trial Locations

Locations (10)

Ginefiv Barcelona; 🇪🇸 Barcelona, Spain

IVI Barcelona; 🇪🇸 Barcelona, Spain

IVI Bilbao; 🇪🇸 Bilbao, Spain

IVI Madrid; 🇪🇸 Madrid, Spain

Ginefiv Madrid; 🇪🇸 Madrid, Spain

IVI Málaga; 🇪🇸 Málaga, Spain

Ginemed Sevilla; 🇪🇸 Sevilla, Spain

IVI Valencia; 🇪🇸 Valencia, Spain

IVI Vigo; 🇪🇸 Vigo, Spain

IVI Zaragoza; 🇪🇸 Zaragoza, Spain