Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies (MULAN)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mullerian Anomaly of Vagina, Mullerian Anomaly of Uterus, Nec, Mullerian Anomaly of Cervix. Basic parameters: up to 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies: a Retrospective Cohort
Overview
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.
Primary outcome measures
- Fertility [Time frame: 10 years after trying to conceive]
- Fertility [Time frame: 18 weeks after conception]
- Surgical approach [Time frame: during surgery]
- Surgical success [Time frame: 15 years after surgery]
Secondary outcome measures (2)
- Diagnostic accuracy [Time frame: at the time of diagnostic workup]
- Obstetric complications [Time frame: 1 year after conception]
Eligibility criteria
Inclusion criteria
- women with a uterus
- presence of a mullerian variation
- Maximum age 45y
Exclusion criteria
- women without a uterus
- aged >45y
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- UZ Ghent — Ghent
Identifiers
NCT: NCT04732546 · B6702020000012