Vaginal MicrobiomeNCT06643065
The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer
An observational study of Vaginal Microbiome, run by Fundación IVI at 10 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Vaginal Microbiome
- How many people
- 1,573 participants
- Where
- 10 sitesSpain
- Study dates
- 17 Jul 2024to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Eligible study participants are female ART patients scheduled for a frozen euploid embryo transfer
Who may be able to join
- ART patients undergoing the transfer of a euploid embryo
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Spain10 sites, 10 recruiting
- Recruiting
Ginefiv Barcelona
Barcelona, 08015
Mauricio Gómez, +34 930 40 02 00, m.gomez@ginefiv.com
Mauricio Gómez
- Recruiting
IVI Barcelona
Barcelona, 08029
Gemma Castillón, +34 651 79 10 00, gemma.castillon@ivirma.com
Gemma Castillón
- Recruiting
IVI Bilbao
Bilbao, 48940
Estefania Abanto, +34 651 79 10 00, estefania.abanto@ivirma.com
Estefania Abanto
- Recruiting
IVI Madrid
Madrid, 28023
Maria Jose Garcia, +34 651 79 10 00, mariajose.garcia@ivirma.com
Maria José Garcia
- Recruiting
Ginefiv Madrid
Madrid, 28043
Loreto López, +34 915 19 75 41, l.lopez@ginefiv.com
Loreto López
- Recruiting
IVI Málaga
Málaga, 29006
Marta García, +34 651 79 10 00, marta.garciasa@ivirma.com
Marta García
- Recruiting
Ginemed Sevilla
Seville, 41010
Pamela Valdivieso, +34 954 99 10 51, pvaldivieso@ginemed.es
Pamela Valdivieso
- Recruiting
IVI Valencia
Valencia, 46015
Elena Labarta, +34 651 79 10 00, Elena.Labarta@ivirma.com
Elena Labarta
- Recruiting
IVI Vigo
Vigo, 36203
Iria Fernández, +34 651 79 10 00, iria.fernandez@ivirma.com
Iria Fernández
- Recruiting
IVI Zaragoza
Zaragoza, 50018
Ana Chueca, +34 651 79 10 00, Ana.Chueca@ivirma.com
Ana Chueca
About this 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
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group-1 | normal microbiome | |
| Group-2 | dysbiotic microbiome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: day of embryo transfer (between days 18 and 21 of the menstrual cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start17 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,573 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación IVI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mina Popovic, Study director, JUNO GENETICS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643065
- Sponsor's protocol ID
- 2403-JUN-096-KS
- Status last verified
- Jun 2026
- First submitted
- 10 Oct 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer: A Prospective Blinded Multicentre Cohort Study
- ClinicalTrials.gov ID
- NCT06643065
- Acronym / sponsor ID
- 2403-JUN-096-KS
- Conditions
- Vaginal Microbiome
- Keywords
- Female reproductive tract microbiome,, Vaginal dysbiosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,573 participants (estimated)
- Lead sponsor
- Fundación IVIUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-1 | – | –normal microbiome |
| Group-2 | – | –dysbiotic microbiome |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Eligible study participants are female ART patients scheduled for a frozen euploid embryo transfer
Key inclusion criteria (1 listed)
- ART patients undergoing the transfer of a euploid embryo
Key exclusion criteria (10 listed)
- Patients with a body mass index (BMI) ≥35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
microbial DNA extraction using molecular techniques such as qPCR
Time frame: day 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mina Popovic study director
JUNO GENETICS
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Microbiome, run by Fundación IVI at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Povey (+34900828420, Courtney.Povey@junogenetics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbial DNA extraction using molecular techniques such as qPCR (time frame: day of embryo transfer (between days 18 and 21 of the menstrual cycle)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.