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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06643065
Enrollment
1573
Registered
2024-10-15
Start date
2024-07-17
Completion date
2027-09-30
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Microbiome

Keywords

Female reproductive tract microbiome,, Vaginal dysbiosis

Brief 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.

Interventions

None listed

Sponsors

Fundación IVI
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 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)

Design outcomes

Primary

MeasureTime frameDescription
microbial DNA extraction using molecular techniques such as qPCRday 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).

Countries

Spain

Contacts

CONTACTCourtney Povey
Courtney.Povey@junogenetics.com+34900828420
STUDY_DIRECTORMina Popovic

JUNO GENETICS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026