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ClinicalTrials.gov ID

NCT06643065

Lead Sponsor

Fundación IVIOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

1,573Estimated

Last Update Posted

Jun 30, 2026Actual

Start Date

Jul 17, 2024Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Sep 30, 2027Estimated

Official Title

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

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.

• Vaginal Microbiome

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

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)

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Fundación IVIOTHER

iria.fernandez@ivirma.com+34 651 79 10 00