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

NCT ID: NCT03405883

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Repeated Implantation Failure Normal Fertile

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RIF (women with repeated implantation failure)

Transfer of at least 5 good quality embryos in IVF or ICSI cycles, without achieving pregnancy

Vaginal swab + endometrial biopsy

Intervention Type OTHER

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

Vaginal swab + endometrial biopsy

Intervention Type OTHER

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

Interventions

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Vaginal swab + endometrial biopsy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Center for Microbial Ecology and Technology - Ghent University

UNKNOWN

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hans Verstraelen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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Ghent University Hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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BE670201733152

Identifier Type: -

Identifier Source: org_study_id

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