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NCT Number: NCT04627818

Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies

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.

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Key information

Conditions

Mullerian Anomaly of Uterus, Nec Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Mullerian Anomaly of Cervix Mullerian Anomaly of Vagina

Age range

Up to 45 year

Sex eligibility

Female

Study type

Observational

Primary location

Ghent University hospital

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Eline Meireson

CONTACT

[email protected]

+3193327817

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • women without a uterus
  • aged >45y

Treatment and study plan

Primary outcomes

  1. Fertility

    Time frame: 10 years after trying to conceive

    Time to clinical pregnancy

  2. Fertility

    Time frame: 18 weeks after conception

    Early pregnancy loss

  3. Surgical approach

    Time frame: During surgery

    Different surgical approaches used

  4. Surgical success

    Time frame: 15 years after surgery

    Relief of symptoms after surgery

Secondary outcomes

  1. 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

  2. Obstetric complications

    Time frame: 1 year after conception

    Complications during pregnancy, labor, delivery, and the postpartum period

Study contacts

Contact information is provided by the study sponsor or research team.

Eline Meireson

CONTACT

[email protected]

093327817 ext. 0032

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: MULAN

Important dates

Study start
2021
Primary completion
2050
Study completion
2050
First posted
Nov 13, 2020
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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