Uterine Microbiome in Women with Repeated Implantation Fa... | NCT03405883

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

NCT03405883

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

13Actual

Phase

Not provided

Conditions

Repeated Implantation Failure
Normal Fertile

Interventions

Vaginal swab + endometrial biopsy

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jan 12, 2018

First Submission Date that Met QC Criteria

Jan 19, 2018

First Posted Date

Jan 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2024

Last Update Posted Date

Sep 19, 2024Actual

Name	Class
University Ghent	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.	NF (normal fertile women)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Midluteal uterine microbiome profile	Descriptive analysis of the uterine microbiome present	1 week

Secondary Outcomes

Measure	Description	Time Frame
Midluteal vaginal microbiome profile	Descriptive analysis of the vaginal microbiome present (quality control of endometrial sampling)	1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans Verstraelen, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent University Hospital		Ghent		9000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided