Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies

Recruiting

• Conditions: Mullerian Anomaly of Uterus, Nec; Mullerian Anomaly of Vagina; Mullerian Anomaly of Cervix

• Registration Number: NCT04627818
• Lead Sponsor: University Hospital, Ghent

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.

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-13
• Study Start: 2021-01-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22
• Primary Completion: 2050-12-31
• Study Completion: 2050-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1500

Inclusion Criteria

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

Exclusion Criteria

• women without a uterus
• aged >45y

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fertility	18 weeks after conception	Early pregnancy loss
Surgical success	15 years after surgery	Relief of symptoms after surgery
Surgical approach	During surgery	Different surgical approaches used

Secondary Outcome Measures

Name	Time	Method
Obstetric complications	1 year after conception	Complications during pregnancy, labor, delivery, and the postpartum period
Diagnostic accuracy	at the time of diagnostic workup	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

Trial Locations

Locations (1)

Ghent University hospital; 🇧🇪 Ghent, Belgium