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

Sponsor

University Hospital, Ghent (Other)

Overall Status

Recruiting

CT.gov ID

NCT04627818

Collaborator

(none)

1,500

Enrollment

Location

360

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mullerian Anomaly of Uterus, Nec Mullerian Anomaly of Vagina Mullerian Anomaly of Cervix

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2050

Anticipated Study Completion Date :

Dec 31, 2050

Arms and Interventions

Arm	Intervention/Treatment
patients with a mullerian variation

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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
Obstetric complications [1 year after conception]
Complications during pregnancy, labor, delivery, and the postpartum period

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

women without a uterus
aged >45y

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghent University hospital	Ghent		Belgium	9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator: Tjalina Hamerlynck, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT04627818

Other Study ID Numbers:

B6702020000011

First Posted:

Nov 13, 2020

Last Update Posted:

Oct 21, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Ghent

Mullerian anomaly

Diagnostic tools

Surgical treatment

Reproductive function

Obstetric complications

Additional relevant MeSH terms:

Congenital Abnormalities

Study Results

No Results Posted as of Oct 21, 2021