Diagnostic, Therapeutic and Reproductive Aspects of Patie... | NCT04627818

Studies
Diagnostic, Therapeutic and Reproductive Aspects of Patients with Mullerian Anomalies

NCT04627818

Sponsor

University Hospital, Ghent

Status

Recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Mullerian Anomaly of Uterus, Nec
Mullerian Anomaly of Vagina
Mullerian Anomaly of Cervix

Interventions

Not provided

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

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Dec 31, 2050Estimated

Completion Date

Dec 31, 2050Estimated

First Submitted Date

Nov 9, 2020

First Submission Date that Met QC Criteria

Nov 9, 2020

First Posted Date

Nov 13, 2020Actual

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

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

The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.

Detailed Description

Mullerian anomalies are rare, therefore they are not well known and not often considered as differential diagnosis. This causes a delay in the diagnosis with risk of long lasting symptoms and adverse effects on the reproductive function. However, the diagnosis can be made more accurately with improved diagnostic tools. Moreover, minimally invasive surgery allows for preservation and potential improvement of fertility in these women.

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

No data available

No data is available for this block.

Enrollment

1,500Estimated

Label	Type	Description	Intervention Names
patients with a mullerian variation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fertility	Time to clinical pregnancy	10 years after trying to conceive
Fertility	Early pregnancy loss	18 weeks after conception
Surgical approach	Different surgical approaches used	During surgery
Surgical success	Relief of symptoms after surgery	15 years after surgery

Secondary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy	The ability of a test to detect a Mullerian variation when it is present and detect the absence of a Mullerian variation when it is absent	at the time of diagnostic workup
Obstetric complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women with a uterus
presence of a mullerian variation
Maximum age 45y

Exclusion Criteria:

women without a uterus
aged >45y

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

women with a uterus

Minimum Age

Not provided

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

diagnosed and/or treated in the Ghent University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eline Meireson	Contact	093327817	0032	eline.meireson@uzgent.be

Overall Officials

Name	Affiliation	Role
Tjalina Hamerlynck	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent University hospital	Recruiting	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

Condition Browse Module

MeSH Terms

ID	Term
D020345	Enterocolitis, Necrotizing

Ancestor Terms

ID	Term
D004760	Enterocolitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided