- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03405883
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
Status
Completed
Conditions
Intervention / Treatment
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
-
-
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Ghent, Belgium, 9000
- Ghent University Hospital
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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
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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.
Sponsor
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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