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

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.

Study Overview

• Status: Completed
• Conditions: Implantation Failure
• Intervention / Treatment: Other: Probiotic

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03016
    • Instituto Bernabeu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 49 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Uterine malformations.
• Not treated hydrosalpinx
• Known factors of implantation failure and repetitive abortions, such as haematological disorders of hypercoagulability.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Not pregnancy; Vaginal probiotic administration	Other: Probiotic; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live newborn rate	Live newborn rate after assisted reproduction technique	45 weeks
Complications during gestation	Complications during gestation after assisted reproduction technique	45 weeks

Collaborators and Investigators

• Sponsor: Instituto Bernabeu

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): May 1, 2019
• Study Completion (ACTUAL): May 1, 2019

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (ACTUAL): May 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: microbiome; fertility; implantation failure; Assisted reproduction
• Other Study ID Numbers: Microbioma2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No