Clinical trial NCT06643065: The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer: a Prospective Blinded Multicentre Cohort Study
Official title: The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer: a Prospective Blinded Multicentre Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vaginal Microbiome
Keywords: Female reproductive tract microbiome,
Vaginal dysbiosis
Lead sponsor: Fundación IVI
Sponsor class: OTHER
Collaborators: name: Juno
First posted: 2024-10-15
Enrollment: 1573
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible study participants are female ART patients scheduled for a frozen euploid embryo transfer

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.


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)

Primary outcomes:
measure: microbial DNA extraction using molecular techniques such as qPCR
timeFrame: day of embryo transfer (between days 18 and 21 of the menstrual cycle)
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Ginefiv Barcelona
city: Barcelona
country: Spain
facility: IVI Barcelona
city: Bilbao
country: Spain
facility: IVI Bilbao
city: Madrid
country: Spain
facility: IVI Madrid
city: Madrid
country: Spain
facility: Ginefiv Madrid
city: Málaga
country: Spain
facility: IVI Málaga
city: Sevilla
country: Spain
facility: Ginemed Sevilla
city: Valencia
country: Spain
facility: IVI Valencia
city: Vigo
country: Spain
facility: IVI Vigo
city: Zaragoza
country: Spain
facility: IVI Zaragoza
Study officials:
affiliation: JUNO GENETICS
name: Antonio Capalbo
role: STUDY_DIRECTOR
References: