The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer

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.

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Key information

Conditions

Vaginal Microbiome

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Ginefiv Barcelona, Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

microbial DNA extraction using molecular techniques such as qPCR

Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Courtney Povey

CONTACT

[email protected]

+34900828420

Sponsors and collaborators

Lead sponsor

Fundación IVI

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Oct 15, 2024
Registry last updated: Jun 30, 2026

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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