ClinicalTrials.gg
RecruitingNCT06643065Updated Jun 30, 2026

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

An observational study in Vaginal Microbiome, sponsored by Fundación IVI. Recruiting at 10 sites in Spain. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Fundación IVI · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,573
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Vaginal Microbiome

Keywords

  • Female reproductive tract microbiome,
  • Vaginal dysbiosis
03

In context

Lead sponsor

Fundación IVI is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ART patients undergoing the transfer of a euploid embryo

Exclusion criteria

Exclusion Criteria:

  • Patients with a (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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,573 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Group-1

    normal microbiome

  • Group-2

    dysbiotic microbiome

06

What researchers measure

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)

07

Study locations

10 of 10 sites recruiting
  • Ginefiv Barcelona
    Barcelona, 08015, Spain
    Recruiting
    • Mauricio Gómez · Contactm.gomez@ginefiv.com · +34 930 40 02 00
    • Mauricio Gómez · Principal investigator
  • IVI Barcelona
    Barcelona, 08029, Spain
    Recruiting
  • IVI Bilbao
    Bilbao, 48940, Spain
    Recruiting
  • IVI Madrid
    Madrid, 28023, Spain
    Recruiting
  • Ginefiv Madrid
    Madrid, 28043, Spain
    Recruiting
    • Loreto López · Contactl.lopez@ginefiv.com · +34 915 19 75 41
    • Loreto López · Principal investigator
  • IVI Málaga
    Málaga, 29006, Spain
    Recruiting
  • Ginemed Sevilla
    Seville, 41010, Spain
    Recruiting
    • Pamela Valdivieso · Contactpvaldivieso@ginemed.es · +34 954 99 10 51
    • Pamela Valdivieso · Principal investigator
  • IVI Valencia
    Valencia, 46015, Spain
    Recruiting
  • IVI Vigo
    Vigo, 36203, Spain
    Recruiting
  • IVI Zaragoza
    Zaragoza, 50018, Spain
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2024 (actual). Primary completion is estimated for Dec 2026, 29 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2024
First posted
Oct 15, 2024
StartActual
Jul 17, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Sep 30, 2027
Last update
Jun 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06643065
Lead sponsor
Fundación IVI
Responsible party
Sponsor
First posted
Oct 15, 2024
Start date
Jul 17, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Jun 30, 2026

Study contacts

Courtney Povey
Contact
Courtney.Povey@junogenetics.com
+34900828420
Mina Popovic
study director · JUNO GENETICS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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