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Completed

NCT Number: NCT03405883

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.

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Key information

Conditions

Repeated Implantation Failure Normal Fertile

Age range

18 year–39 year

Sex eligibility

Female

Study type

Observational

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Midluteal uterine microbiome profile

    Time frame: 1 week

    Descriptive analysis of the uterine microbiome present

Secondary outcomes

  1. Midluteal vaginal microbiome profile

    Time frame: 1 week

    Descriptive analysis of the vaginal microbiome present (quality control of endometrial sampling)

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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