The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Vaginal Microbiome. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer: A Prospective Blinded Multicentre Cohort Study
Overview
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.
Primary outcome measures
- microbial DNA extraction using molecular techniques such as qPCR [Time frame: day of embryo transfer (between days 18 and 21 of the menstrual cycle)]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 10 centers
- Ginefiv Barcelona — Barcelona
- IVI Barcelona — Barcelona
- IVI Bilbao — Bilbao
- IVI Madrid — Madrid
- Ginefiv Madrid — Madrid
- IVI Málaga — Málaga
- Ginemed Sevilla — Seville
- IVI Valencia — Valencia
- … and 2 more centers
Identifiers
NCT: NCT06643065 · 2403-JUN-096-KS