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

NCT03405883 — Completed, 13 participants, University Hospital, Ghent

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

Registry	NCT03405883
Status	Completed
Study type	Observational
Enrollment	13 (Actual)
Sponsor	University Hospital, Ghent (Other); collaborators: University Ghent
Conditions	Repeated Implantation Failure, Normal Fertile
Interventions	Vaginal swab + endometrial biopsy (Other)
Dates	start 2018-01-01, primary completion 2018-12-31, completion 2018-12-31, first posted 2018-01-23, last updated 2024-09-19
Locations	1 site in Belgium

-Summary

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

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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
RIF (women with repeated implantation failure)		Other: Vaginal swab + endometrial biopsy	Transfer of at least 5 good quality embryos in IVF or ICSI cycles, without achieving pregnancy
NF (normal fertile women)		Other: Vaginal swab + endometrial biopsy	Spontaneous conception or conception after max 9 IUI cycles

Vaginal swab + endometrial biopsy (Other): In the midluteal phase of the cycle, a vaginal swab (E swab) and endometrial biopsy (TAO brush) will be obtained.

+Outcome measures

Primary outcomes

Midluteal uterine microbiome profile [1 week]: Descriptive analysis of the uterine microbiome present

Secondary outcomes

Midluteal vaginal microbiome profile [1 week]: Descriptive analysis of the vaginal microbiome present (quality control of endometrial sampling)

+Eligibility

Sex: Female, ages: 18 Years to 39 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Ghent University Hospital	Ghent	Belgium

+Investigators

Hans Verstraelen, MD, PhD, Principal investigator, University Hospital, Ghent

My Notes

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