- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04627818
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies (MULAN)
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies: a Prospective Cohort
Study Overview
Status
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Eline Meireson
- Phone Number: 0032 093327817
- Email: eline.meireson@uzgent.be
Study Locations
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Ghent, Belgium, 9000
- Recruiting
- Ghent University Hospital
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Contact:
- Eline Meireson
- Phone Number: +3193327817
- Email: eline.meireson@uzgent.be
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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patients with a mullerian variation
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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
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10 years after trying to conceive
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Fertility
Time Frame: 18 weeks after conception
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Early pregnancy loss
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18 weeks after conception
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Surgical approach
Time Frame: During surgery
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Different surgical approaches used
|
During surgery
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Surgical success
Time Frame: 15 years after surgery
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Relief of symptoms after surgery
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15 years after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy
Time Frame: at the time of diagnostic workup
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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
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at the time of diagnostic workup
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Obstetric complications
Time Frame: 1 year after conception
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Complications during pregnancy, labor, delivery, and the postpartum period
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1 year after conception
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tjalina Hamerlynck, University Hospital, Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B6702020000011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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