IVFMICROFIVNCT04820985
Analysis of the Composition of the Vaginal Microbiota During IVF Treatment and Correlation With Serum Progesterone Level on the Day of Embryo Transfer
An observational study of IVF, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The composition of the vaginal microbiota varies throughout a woman's life and is sensitive to hormonal and environmental factors. Specifically, hormonal treatments necessary in the medically assisted procreation (MAP) processes can influence the vaginal microbiota. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- IVF
- What is being tested?
- Vaginal swab and Blood test
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2021to 22 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years
- Women only
- Adult
Study population: Patients aged 18 to 40 inclusive, Round1 or 2 of IVF or IVF-ICSI with fresh embryo transfer, without taking antibiotics in the 3 months preceding the first sample treated in the AMP center of the CHU de Nîmes.
Who may be able to join
- Patient in round 1 or 2 of IVF or IVF-ICSI with transfer of a fresh embryo with a normal preimplantation assessment, without antibiotic treatment in the 3 months preceding the sample.
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Who cannot join
- Use of antibiotics in the 3 months preceding the sample.
- Patient presenting an anomaly in the implantation assessment.
- Presence of uterine malformation, hydrosalpinx, chronic vaginosis.
- Patient undergoing a protocol to study endometrial receptivity.
- Patient of African American, African or Latin American origin (patients born to two parents of Hispanic origin) as people of African and Hispanic origin have a type IV flora vs people of Caucasian origins who have type I, II, III and V of the Ravel classification .
- Cancellation of the procedure for various reasons (stimulation failure, collection failure, fertilization failure or embryonic segmentation).
Show all 11Show fewer
- Patient taking a freeze-all approach (freezing of the embryos) for various causes (risk of ovarian hyperstimulation, increase in progesterone, too thin endometrium, etc.).
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analyse de la Composition du Microbiote Vaginal à différents Temps de la Prise en Charge en FIV et corrélation Avec le Taux de progestérone sérique le Jour du Transfert d'Embryon
The composition of the vaginal microbiota varies throughout a woman's life and is sensitive to hormonal and environmental factors. Specifically, hormonal treatments necessary in the medically assisted procreation (MAP) processes can influence the vaginal microbiota. New sequencing techniques have been used to characterize the vaginal microbiota, demonstrating that the microbiota could be divided into 5 classes. The composition of the vaginal microbiota seems to have an implication in the evolution of a pregnancy after IVF. It is therefore essential to have more data on the evolution of the vaginal microbiota at the different stages of IVF treatment and to analyze whether this evolution can be predictive of the success of embryo implantation. Good endometrial progesterone impregnation is an essential prerequisite for ensuring embryo implantation. Indeed, supporting the luteal phase through vaginal progesterone is an essential step in IVF protocols to ensure synchronization between endometrial maturation and embryonic age. However, the serum progesterone level on the day of embryo transfer varies widely between patients. Several factors such as age, vaginal mucosa trophicity, estrogen impregnation and sexual activity are known to affect the vaginal absorption of progesterone. The treatments and vaginal examinations performed during the IVF procedure could also have an impact on the constitution of the vaginal microbiota. The hypothesis of this research is that there is an alteration in the vaginal microbiota during the IVF process which may alter the absorption of vaginal progesterone, with an impact on the failure or success of embryo implantation.
- Conditions
- IVF
- Being tested
- Vaginal swab, Blood test
- Keywords
- Pregnancy, vaginal microbiota, Progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal swabOther
Vaginal flora swab 3 months before stimulation, at oocyte puncture, embryo transfer and beta-human chorionic gonadotropin dosing
Blood testOther
Blood sample to measure plasma dose of progesterone
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing IVF | Not described Receives: Other: Vaginal swab; Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Class of vaginal flora according to community state type
Classified into 5 classes of vaginal flora described according to Smith \& Ravel 2017
Measured: 3 Months before ovarian stimulation
Microbiota richness of vaginal flora
Measured by operational taxonomic unit
Measured: 3 Months before ovarian stimulation
Microbiota alpha diversity of vaginal flora
Shannon Index
Measured: 3 Months before ovarian stimulation
Microbiota beta diversity of vaginal flora
Bray Curtis index
Measured: 3 Months before ovarian stimulation
Plasma progesterone level on the day of embryo transfer
Measured by chemiluminescence (nmol/L)
Measured: Day of embryo transfer (Day 0)
Secondary outcomes (16)
Class of vaginal flora according to community state type
Classified into 5 classes of vaginal flora described according to Smith \& Ravel 2017
Measured: Day of oocyte puncture (Month 3)
Class of vaginal flora according to community state type
Classified into 5 classes of vaginal flora described according to Smith \& Ravel 2017
Measured: Day of embryo transfer (Day 93)
Class of vaginal flora according to community state type
Classified into 5 classes of vaginal flora described according to Smith \& Ravel 2017
Measured: Day of beta-human chorionic gonadotropin dosage (Day 108)
Microbiota richness of vaginal flora
Measured by operational taxonomic unit
Measured: Day of oocyte puncture (Month 3)
Microbiota richness of vaginal flora
Measured by operational taxonomic unit
Measured: Day of embryo transfer (Day 93)
Microbiota richness of vaginal flora
Measured by operational taxonomic unit
Measured: Day of beta-human chorionic gonadotropin dosage (Day 108)
Microbiota alpha diversity of vaginal flora
Shannon Index
Measured: Day of oocyte puncture (Month 3)
Microbiota alpha diversity of vaginal flora
Shannon Index
Measured: Day of embryo transfer (Day 93)
Microbiota alpha diversity of vaginal flora
Shannon Index
Measured: Day of beta-human chorionic gonadotropin dosage (Day 108)
Microbiota beta diversity of vaginal flora
Bray Curtis index
Measured: Day of oocyte puncture (Month 3)
Microbiota beta diversity of vaginal flora
Bray Curtis index
Measured: Day of embryo transfer (Day 93)
Microbiota beta diversity of vaginal flora
Bray Curtis index
Measured: Day of beta-human chorionic gonadotropin dosage (Day 108)
Pregnancy success
Yes/No
Measured: Month 3
Pregnancy progression
Implantation failure/progression/miscarriage
Measured: Month 3
Treatments received for IVF
Description of treatments, taken from patient file
Measured: Month 3
Plasma progesterone level
Measured by chemiluminescence (nmol/L)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start26 May 2021
- Primary completion11 Jan 2023
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie Huberlant, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820985
- Sponsor's protocol ID
- NIMAO/2020-01/SH-01
- Acronym
- MICROFIV
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2021
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith SB, Ravel J. The vaginal microbiota, host defence and reproductive physiology. J Physiol. 2017 Jan 15;595(2):451-463. doi: 10.1113/JP271694. Epub 2016 May 5.
PubMed 27373840
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyse de la Composition du Microbiote Vaginal à différents Temps de la Prise en Charge en FIV et corrélation Avec le Taux de progestérone sérique le Jour du Transfert d'Embryon
- ClinicalTrials.gov ID
- NCT04820985
- Acronym / sponsor ID
- MICROFIV / NIMAO/2020-01/SH-01
- Conditions
- IVF
- Keywords
- Pregnancy, vaginal microbiota, Progesterone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 29 Mar 2021 (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.
The composition of the vaginal microbiota varies throughout a woman's life and is sensitive to hormonal and environmental factors. Specifically, hormonal treatments necessary in the medically assisted procreation (MAP) processes can influence the vaginal microbiota. New sequencing techniques have been used to characterize the vaginal microbiota, demonstrating that the microbiota could be divided into 5 classes. The composition of the vaginal microbiota seems to have an implication in the evolution of a pregnancy after IVF. It is therefore essential to have more data on the evolution of the vaginal microbiota at the different stages of IVF treatment and to analyze whether this evolution can be predictive of the success of embryo implantation. Good endometrial progesterone impregnation is an essential prerequisite for ensuring embryo implantation. Indeed, supporting the luteal phase through vaginal progesterone is an essential step in IVF protocols to ensure synchronization between endometrial maturation and embryonic age. However, the serum progesterone level on the day of embryo transfer varies widely between patients. Several factors such as age, vaginal mucosa trophicity, estrogen impregnation and sexual activity are known to affect the vaginal absorption of progesterone. The treatments and vaginal examinations performed during the IVF procedure could also have an impact on the constitution of the vaginal microbiota. The hypothesis of this research is that there is an alteration in the vaginal microbiota during the IVF process which may alter the absorption of vaginal progesterone, with an impact on the failure or success of embryo implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing IVF | – | Other: Vaginal swab, Other: Blood test |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients aged 18 to 40 inclusive, Round1 or 2 of IVF or IVF-ICSI with fresh embryo transfer, without taking antibiotics in the 3 months preceding the first sample treated in the AMP center of the CHU de Nîmes.
Key inclusion criteria (3 listed)
- Patient in round 1 or 2 of IVF or IVF-ICSI with transfer of a fresh embryo with a normal preimplantation assessment, without antibiotic treatment in the 3 months preceding the sample.
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Key exclusion criteria (11 listed)
- Use of antibiotics in the 3 months preceding the sample.
- Patient presenting an anomaly in the implantation assessment.
- Presence of uterine malformation, hydrosalpinx, chronic vaginosis.
- Patient undergoing a protocol to study endometrial receptivity.
- Patient of African American, African or Latin American origin (patients born to two parents of Hispanic origin) as people of African and Hispanic origin have a type IV flora vs people of Caucasian origins who have type I, II, III and V of the Ravel classification .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal swabVaginal flora swab 3 months before stimulation, at oocyte puncture, embryo transfer and beta-human chorionic gonadotropin dosing | Other | Women undergoing IVF |
| Blood testBlood sample to measure plasma dose of progesterone | Other | Women undergoing IVF |
Primary outcome
Class of vaginal flora according to community state type
Time frame: 3 Months before ovarian stimulation
Classified into 5 classes of vaginal flora described according to Smith \& Ravel 2017
Microbiota richness of vaginal flora
Time frame: 3 Months before ovarian stimulation
Measured by operational taxonomic unit
Microbiota alpha diversity of vaginal flora
Time frame: 3 Months before ovarian stimulation
Shannon Index
Microbiota beta diversity of vaginal flora
Time frame: 3 Months before ovarian stimulation
Bray Curtis index
Plasma progesterone level on the day of embryo transfer
Time frame: Day of embryo transfer (Day 0)
Measured by chemiluminescence (nmol/L)
16 secondary outcomes
Class of vaginal flora according to community state type
Time frame: Day of oocyte puncture (Month 3)
Class of vaginal flora according to community state type
Time frame: Day of embryo transfer (Day 93)
Class of vaginal flora according to community state type
Time frame: Day of beta-human chorionic gonadotropin dosage (Day 108)
Microbiota richness of vaginal flora
Time frame: Day of oocyte puncture (Month 3)
Microbiota richness of vaginal flora
Time frame: Day of embryo transfer (Day 93)
Microbiota richness of vaginal flora
Time frame: Day of beta-human chorionic gonadotropin dosage (Day 108)
Microbiota alpha diversity of vaginal flora
Time frame: Day of oocyte puncture (Month 3)
Microbiota alpha diversity of vaginal flora
Time frame: Day of embryo transfer (Day 93)
Microbiota alpha diversity of vaginal flora
Time frame: Day of beta-human chorionic gonadotropin dosage (Day 108)
Microbiota beta diversity of vaginal flora
Time frame: Day of oocyte puncture (Month 3)
Microbiota beta diversity of vaginal flora
Time frame: Day of embryo transfer (Day 93)
Microbiota beta diversity of vaginal flora
Time frame: Day of beta-human chorionic gonadotropin dosage (Day 108)
Pregnancy success
Time frame: Month 3
Pregnancy progression
Time frame: Month 3
Treatments received for IVF
Time frame: Month 3
Plasma progesterone level
Time frame: Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Background: PubMed 27373840Smith SB, Ravel J. The vaginal microbiota, host defence and reproductive physiology. J Physiol. 2017 Jan 15;595(2):451-463. doi: 10.1113/JP271694. Epub 2016 May 5.
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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. This study is not recruiting at the moment.
Stéphanie Huberlant principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IVF, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Class of vaginal flora according to community state type (time frame: 3 Months before ovarian stimulation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04820985, which also lists 1 linked publication.
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 26 Apr 2024.