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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorFundación IVI

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

ART patients undergoing the transfer of a euploid embryo

Disqualifiers

Patients with a body mass index (BMI) ≥35

Patients with uncorrected uterine malformations

Patients with a unicornuate uterus

Patients with a bicornuate uterus

Trial population

Eligible study participants are female ART patients scheduled for a frozen euploid embryo transfer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,573 Participants
are grouped into 2 trial groups
Group A: Group-1
Group B: Group-2

Trial outcomes

Primary outcomes

1

microbial DNA extraction using molecular techniques such as qPCR

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).

Time frame
day of embryo transfer (between days 18 and 21 of the menstrual cycle)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.