Implantation FailureRIFMicrobiomeNCT03153787
Vaginal Microbiome Influence on the Results of Assisted Reproduction Techniques
A study testing Probiotic in people with Implantation Failure, run by Instituto Bernabeu at 1 site in Spain.
Trial summary
The objective of the present study to analyze the vaginal microbiome in patients who have not achieved gestation after oocyte donation treatment and after probiotic administration. All patients will receive vaginal probiotic according to the standard regimen. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women only
- Conditions the study is for
- Implantation Failure
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2017to 1 May 2019
- Phase
- Interventional
- 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 19 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Treated by oocyte donation.
- Transfer of a single euploid embryo in the blastocyst phase.
- <3 months prior without antibiotic treatment.
- Women who have completed the previous observational study "Study of the influence of vaginal and endometrial microbiome on the results of assisted reproduction techniques".
- Women who have not achieved gestation after treatment.
- Signed informed consent form.
Who cannot join
- Uterine malformations.
- Not treated hydrosalpinx
- Known factors of implantation failure and repetitive abortions, such as haematological disorders of hypercoagulability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Vaginal and Endometrial Microbiome on the Results of Assisted Reproduction Techniques and Probiotic Administration Effect: Controlled Before-and-after Study
The objective of the present study to analyze the vaginal microbiome in patients who have not achieved gestation after oocyte donation treatment and after probiotic administration.
All patients will receive vaginal probiotic according to the standard regimen. Sample collection will be performed the embryo transfer day and on the day of the pregnancy test. Follow up of gestation will be carried out.
The analysis of the vaginal microbiome will be performed though massive genetic sequencing (determination of 16SRNA).
The study variables, among others, are vaginal microbiome pattern after probiotic administration, the gestation rate, and the abortion rate.
Read the detailed description
This study will be performed after the observational study "Vaginal microbiome influence on the results of assisted reproduction techniques". The main goal of this previous study will be to identify patterns of vaginal and / or endometrial microbiome in relation to the gestation rate in women with implantation failure and / or repeat abortions who undergo an oocyte donation treatment. The vaginal and endometrial microbiome of women with (i) implantation failure, (ii) repeat abortions and (iii) control group without implantation failure or repeat abortions, will be analyzed before and after the embryo transfer.
Those women who do not achieve pregnancy will be eligible for the present study. The objective of the present study to analyze the vaginal microbiome in patients who have not achieved gestation after oocyte donation treatment and after probiotic administration.
All patients will receive vaginal probiotic according to the standard regimen: 1 tablet (via vaginal) for 5 days after menstruation during the same cycle of the next embryo transfer.
The vaginal sample will be analyzed after taking the probiotic. Sample collection will be performed the embryo transfer day and on the day of the pregnancy test. Follow up of gestation will be carried out.
Vaginal sample collection: obtention of vaginal fluid with vaginal swab by direct visualization. Direct visualization means having the patient in a lithotomy position, like a routine gynecological examination by visualization with a vaginal speculum.
The analysis of the vaginal microbiome will be performed though massive genetic sequencing (determination of 16SRNA). First of all, the extraction of RNA and subsequent analysis. We will analyze the groups of microorganisms, as well as the determination of patterns related to failure of implantation, repetitive abortions and gestation success.
The study variables, among others, are vaginal microbiome pattern after probiotic administration, the gestation rate, and the abortion rate. The vaginal microbiome will be compared with the results of the previous observational study.
- Conditions
- Implantation Failure
- Being tested
- Probiotic
- Keywords
- implantation failure, fertility, microbiome, Assisted reproduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticOther
Vaginal probiotic administration according to the standard regimen: 1 tablet (via vaginal) for 5 days after menstruation during the same cycle of the next embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| Not pregnancy | Experimental | Vaginal probiotic administration Receives: Other: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Vaginal microbiome at 2 and 4 weeks
Vaginal microbiome will be analyzed through massive genetic sequencing (determination of 16S RRNA) Before and after probiotic administration
Measured: 2 weeks and 4 weeks
Gestation rate
Gestation rate after assisted reproduction technique
Measured: 4 weeks
Abortion rate
Abortion rate (clinical and biochemical) after assisted reproduction technique
Measured: 45 weeks
Secondary outcomes (2)
Live newborn rate
Live newborn rate after assisted reproduction technique
Measured: 45 weeks
Complications during gestation
Complications during gestation after assisted reproduction technique
Measured: 45 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Jun 2017
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implantation FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Bernabeu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Bernabeu García, Instituto Bernabeu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153787
- Sponsor's protocol ID
- Microbioma2017
- Acronym
- RIFMicrobiome
- Status last verified
- Mar 2022
- First submitted
- 10 May 2017
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Vaginal and Endometrial Microbiome on the Results of Assisted Reproduction Techniques and Probiotic Administration Effect: Controlled Before-and-after Study
- ClinicalTrials.gov ID
- NCT03153787
- Acronym / sponsor ID
- RIFMicrobiome / Microbioma2017
- Conditions
- Implantation Failure
- Keywords
- implantation failure, fertility, microbiome, Assisted reproduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Instituto BernabeuUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 15 May 2017 (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 objective of the present study to analyze the vaginal microbiome in patients who have not achieved gestation after oocyte donation treatment and after probiotic administration.
All patients will receive vaginal probiotic according to the standard regimen. Sample collection will be performed the embryo transfer day and on the day of the pregnancy test. Follow up of gestation will be carried out.
The analysis of the vaginal microbiome will be performed though massive genetic sequencing (determination of 16SRNA).
The study variables, among others, are vaginal microbiome pattern after probiotic administration, the gestation rate, and the abortion rate.
Detailed description
This study will be performed after the observational study "Vaginal microbiome influence on the results of assisted reproduction techniques". The main goal of this previous study will be to identify patterns of vaginal and / or endometrial microbiome in relation to the gestation rate in women with implantation failure and / or repeat abortions who undergo an oocyte donation treatment. The vaginal and endometrial microbiome of women with (i) implantation failure, (ii) repeat abortions and (iii) control group without implantation failure or repeat abortions, will be analyzed before and after the embryo transfer.
Those women who do not achieve pregnancy will be eligible for the present study. The objective of the present study to analyze the vaginal microbiome in patients who have not achieved gestation after oocyte donation treatment and after probiotic administration.
All patients will receive vaginal probiotic according to the standard regimen: 1 tablet (via vaginal) for 5 days after menstruation during the same cycle of the next embryo transfer.
The vaginal sample will be analyzed after taking the probiotic. Sample collection will be performed the embryo transfer day and on the day of the pregnancy test. Follow up of gestation will be carried out.
Vaginal sample collection: obtention of vaginal fluid with vaginal swab by direct visualization. Direct visualization means having the patient in a lithotomy position, like a routine gynecological examination by visualization with a vaginal speculum.
The analysis of the vaginal microbiome will be performed though massive genetic sequencing (determination of 16SRNA). First of all, the extraction of RNA and subsequent analysis. We will analyze the groups of microorganisms, as well as the determination of patterns related to failure of implantation, repetitive abortions and gestation success.
The study variables, among others, are vaginal microbiome pattern after probiotic administration, the gestation rate, and the abortion rate. The vaginal microbiome will be compared with the results of the previous observational study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Not pregnancy | Experimental | Other: ProbioticVaginal probiotic administration |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Treated by oocyte donation.
- Transfer of a single euploid embryo in the blastocyst phase.
- <3 months prior without antibiotic treatment.
- Women who have completed the previous observational study "Study of the influence of vaginal and endometrial microbiome on the results of assisted reproduction techniques".
- Women who have not achieved gestation after treatment.
Key exclusion criteria (3 listed)
- Uterine malformations.
- Not treated hydrosalpinx
- Known factors of implantation failure and repetitive abortions, such as haematological disorders of hypercoagulability.
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 |
|---|---|---|
| ProbioticVaginal probiotic administration according to the standard regimen: 1 tablet (via vaginal) for 5 days after menstruation during the same cycle of the next embryo transfer. | Other | Not pregnancy |
Primary outcome
Change from Baseline Vaginal microbiome at 2 and 4 weeks
Time frame: 2 weeks and 4 weeks
Vaginal microbiome will be analyzed through massive genetic sequencing (determination of 16S RRNA) Before and after probiotic administration
Gestation rate
Time frame: 4 weeks
Gestation rate after assisted reproduction technique
Abortion rate
Time frame: 45 weeks
Abortion rate (clinical and biochemical) after assisted reproduction technique
2 secondary outcomes
Live newborn rate
Time frame: 45 weeks
Complications during gestation
Time frame: 45 weeks
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 31 Mar 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Implantation Failure, run by Instituto Bernabeu at 1 site 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 6 inclusion and 3 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 31 Mar 2022. 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 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?
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?
Change from Baseline Vaginal microbiome at 2 and 4 weeks (time frame: 2 weeks and 4 weeks). The study lists 3 primary outcomes in all. 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 31 Mar 2022.