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

December 21, 2023 updated by: University Hospital, Ghent

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

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 Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • East Flanders
      • Ghent, East Flanders, Belgium, 9000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 41 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

diagnosed and/or treated in the Ghent University Hospital

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • women without a uterus
  • aged >45y

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
patients with a mullerian variation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: 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
at the time of diagnostic workup
Obstetric complications
Time Frame: 1 year after conception
Complications during pregnancy, labor, delivery, and the postpartum period
1 year after conception

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Tjalina Hamerlynck, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2000

Primary Completion (Actual)

December 31, 2020

Study Completion (Estimated)

December 31, 2050

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

January 26, 2021

First Posted (Actual)

February 1, 2021

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B6702020000012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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