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

NCT06643065 | Recruiting

• 1 other identifier: 2403-JUN-096-KS
• Study Type: observational
• Target: 1,573
• Locations: 1 country
• Sites: 10

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.

Conditions

Vaginal Microbiome

Keywords

Female reproductive tract microbiome,; Vaginal dysbiosis

Outcome Measures

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).

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

Study Arms (2)

Group-1

normal microbiome

Group-2

dysbiotic microbiome

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ART patients undergoing the transfer of a euploid embryo

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fundación IVI: lead
• Juno: collaborator

Study Sites (10)

Ginefiv Barcelona

Barcelona, Barcelona, 08015, Spain

RECRUITING

IVI Barcelona

Barcelona, Barcelona, 08029, Spain

RECRUITING

IVI Bilbao

Bilbao, Bilbao, 48940, Spain

RECRUITING

IVI Madrid

Madrid, Madrid, 28023, Spain

RECRUITING

Ginefiv Madrid

Madrid, Madrid, 28043, Spain

RECRUITING

IVI Málaga

Málaga, Málaga, 29006, Spain

RECRUITING

Ginemed Sevilla

Seville, Sevilla, 41010, Spain

RECRUITING

IVI Valencia

Valencia, Valencia, 46015, Spain

RECRUITING

IVI Vigo

Vigo, Vigo, 36203, Spain

RECRUITING

IVI Zaragoza

Zaragoza, Zaragoza, 50018, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

vaginal swabs and blood draws

Study Officials

• Antonio Capalbo

  JUNO GENETICS

  STUDY DIRECTOR

Central Study Contacts

Katharina Spath

CONTACT

+39 0687165737; Katharina.spath@junogenetics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: July 17, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

ES (10)