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

Launched by FUNDACIÓN IVI · Oct 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the role of bacteria in the vagina, known as the vaginal microbiome, and how it might affect pregnancy success in women undergoing fertility treatments. Researchers want to find out if having certain types of vaginal bacteria is linked to an increased risk of pregnancy failure after transferring a healthy embryo. This is important because if a connection is found, it could lead to new recommendations for testing and treatment to help improve the chances of a successful pregnancy.

To participate in this study, women must be receiving assisted reproductive technology (ART) and be preparing to have a euploid (normal) embryo transferred. However, some women may not be eligible if they have certain health conditions, such as a high body mass index or specific uterine problems. Participants can expect to contribute to our understanding of how vaginal bacteria can impact pregnancy outcomes, and if an imbalance is detected, their doctors may provide suggestions for treatments that could help restore a healthy vaginal environment. This trial is currently recruiting participants who meet the criteria.

Gender

FEMALE

Eligibility criteria

• 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)