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

Repeated Implantation Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405883
• Other study ID #: BE670201733152
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2019
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Normal Fertile
• Repeated Implantation Failure

Intervention

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

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Center for Microbial Ecology and Technology - Ghent University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Midluteal uterine microbiome profile	Descriptive analysis of the uterine microbiome present	1 week
Secondary	Midluteal vaginal microbiome profile	Descriptive analysis of the vaginal microbiome present (quality control of endometrial sampling)	1 week