Uterine Microbiome in Women With Repeated Implantation Failure and Normal Fertile Women

December 19, 2022 updated by: University Hospital, Ghent

Comparative Analysis of the Uterine Microbiome in Women With Repeated Implantation Failure and Normal Fertile Women

Characterization of the uterine microbiome in women with repeated implantation failure as well as in normal fertile women.

Study Overview

Detailed Description

In the midluteal phase of the cycle, a vaginal swab and endometrial biopsy will be obtained.

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ghent, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

  • For RIF women: absence of pregnancy after transfer of in total 5 embryos of high quality embryos
  • For NF women: live birth after spontaneous conception or IUI (max 9x)

Description

Inclusion Criteria:

  • Women between their 18th and 40th birthdays (max 39 years and 364 days at the day of signing the informed consent)
  • Able to understand, read and speak Dutch and hence to provide written and oral informed consent
  • Negative serological tests for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), Rapid plasma reagin (RPR) for syphilis

Exclusion Criteria:

  • Hormonal contraception in current cycle
  • Presence of intra-uterine device
  • Antibiotic treatment in the current cycle

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RIF (women with repeated implantation failure)
Transfer of at least 5 good quality embryos in IVF or ICSI cycles, without achieving pregnancy
In the midluteal phase of the cycle, a vaginal swab (E swab) and endometrial biopsy (TAO brush) will be obtained.
NF (normal fertile women)
Spontaneous conception or conception after max 9 IUI cycles
In the midluteal phase of the cycle, a vaginal swab (E swab) and endometrial biopsy (TAO brush) will be obtained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Midluteal uterine microbiome profile
Time Frame: 1 week
Descriptive analysis of the uterine microbiome present
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Midluteal vaginal microbiome profile
Time Frame: 1 week
Descriptive analysis of the vaginal microbiome present (quality control of endometrial sampling)
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hans Verstraelen, MD, PhD, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

January 12, 2018

First Submitted That Met QC Criteria

January 19, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • BE670201733152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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