Skip to main content
Clinical Trials/NCT04627818
NCT04627818
Recruiting
Not Applicable

Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies: a Prospective Cohort

University Hospital, Ghent1 site in 1 country1,500 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mullerian Anomaly of Uterus, Nec
Sponsor
University Hospital, Ghent
Enrollment
1500
Locations
1
Primary Endpoint
Fertility
Status
Recruiting
Last Updated
2 years ago

Overview

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. 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
December 31, 2050
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • women without a uterus
  • aged \>45y

Outcomes

Primary Outcomes

Fertility

Time Frame: 18 weeks after conception

Early pregnancy loss

Surgical success

Time Frame: 15 years after surgery

Relief of symptoms after surgery

Surgical approach

Time Frame: During surgery

Different surgical approaches used

Secondary Outcomes

  • Diagnostic accuracy(at the time of diagnostic workup)
  • Obstetric complications(1 year after conception)

Study Sites (1)

Loading locations...

Similar Trials