Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies (MULAN)

Mullerian Anomaly of Uterus, Nec Clinical Trial

— MULAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04732546
• Other study ID #: B6702020000012
• Status: Recruiting
• Start date: January 1, 2000
• Est. completion date: December 31, 2050

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: Eline Meireson
• Phone: 093327817
• Email: eline.meireson[@]uzgent.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2050
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 45 Years

Eligibility

Inclusion Criteria:

• women with a uterus

• presence of a mullerian variation

• Maximum age 45y

Exclusion Criteria:

• women without a uterus

• aged >45y

Related Conditions & MeSH terms

• Congenital Abnormalities
• Mullerian Anomaly of Cervix
• Mullerian Anomaly of Uterus, Nec
• Mullerian Anomaly of Vagina

Locations

Country	Name	City	State
Belgium	UZ Ghent	Ghent	East Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertility	Time to clinical pregnancy	10 years after trying to conceive
Primary	Fertility	Early pregnancy loss	18 weeks after conception
Primary	Surgical approach	Different surgical approaches used	during surgery
Primary	Surgical success	Relief of symptoms after surgery	15 years after surgery
Secondary	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
Secondary	Obstetric complications	Complications during pregnancy, labor, delivery, and the postpartum period	1 year after conception