Vaginal Microbiome Influence on the Results of Assisted Reproduction Techniques
RIFMicrobiome
Influence of Vaginal and Endometrial Microbiome on the Results of Assisted Reproduction Techniques and Probiotic Administration Effect: Controlled Before-and-after Study
1 other identifier
interventional
69
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2017
CompletedFirst Posted
Study publicly available on registry
May 15, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMarch 31, 2022
March 1, 2022
1.9 years
May 10, 2017
March 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
2 weeks and 4 weeks
Gestation rate
Gestation rate after assisted reproduction technique
4 weeks
Abortion rate
Abortion rate (clinical and biochemical) after assisted reproduction technique
45 weeks
Secondary Outcomes (2)
Live newborn rate
45 weeks
Complications during gestation
45 weeks
Study Arms (1)
Not pregnancy
EXPERIMENTALVaginal probiotic administration
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Uterine malformations.
- Not treated hydrosalpinx
- Known factors of implantation failure and repetitive abortions, such as haematological disorders of hypercoagulability.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Bernabeu
Alicante, 03016, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 10, 2017
First Posted
May 15, 2017
Study Start
June 1, 2017
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share