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Recruiting Observational

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

NCT06643065 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2024-07-17
Last updated
2026-06-30

Condition(s) studied

Vaginal Microbiome

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

Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • 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 sites (10)

FacilityCityRegionStatus
Ginefiv Barcelona Barcelona Spain Recruiting
IVI Barcelona Barcelona Spain Recruiting
IVI Bilbao Bilbao Spain Recruiting
IVI Madrid Madrid Spain Recruiting
Ginefiv Madrid Madrid Spain Recruiting
IVI Málaga Málaga Spain Recruiting
Ginemed Sevilla Seville Spain Recruiting
IVI Valencia Valencia Spain Recruiting
IVI Vigo Vigo Spain Recruiting
IVI Zaragoza Zaragoza Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06643065 on ClinicalTrials.gov ↗ ← All trials in Spain