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

Completed

• Conditions: Repeated Implantation Failure; Normal Fertile
• Interventions: Other: Vaginal swab + endometrial biopsy

• Registration Number: NCT03405883
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-23
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-10
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Midluteal uterine microbiome profile	1 week	Descriptive analysis of the uterine microbiome present

Secondary Outcome Measures

Name	Time	Method
Midluteal vaginal microbiome profile	1 week	Descriptive analysis of the vaginal microbiome present (quality control of endometrial sampling)

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium