NCT03405883

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

12 months

First QC Date

January 12, 2018

Last Update Submit

September 5, 2024

Conditions

Repeated Implantation FailureNormal Fertile

Outcome Measures

Primary Outcomes (1)

  • Midluteal uterine microbiome profile

    Descriptive analysis of the uterine microbiome present

    1 week

Secondary Outcomes (1)

  • Midluteal vaginal microbiome profile

    1 week

Study Arms (2)

RIF (women with repeated implantation failure)

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

Other: Vaginal swab + endometrial biopsy

NF (normal fertile women)

Spontaneous conception or conception after max 9 IUI cycles

Other: Vaginal swab + endometrial biopsy

Interventions

Vaginal swab + endometrial biopsyOTHER

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

NF (normal fertile women)RIF (women with repeated implantation failure)

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* For RIF women: absence of pregnancy after transfer of in total 5 embryos of high quality embryos * For NF women: live birth after spontaneous conception or IUI (max 9x)

You may qualify if:

  • 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

You may not qualify if:

  • Hormonal contraception in current cycle
  • Presence of intra-uterine device
  • Antibiotic treatment in the current cycle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microbiome analysis using 16S ribosomal RNA sequencing

Study Officials

  • Hans Verstraelen, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 23, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

BE(1)