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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04732546

Acronym

MULAN

Enrollment

1000

Registered

2021-02-01

Start date

2000-01-01

Completion date

2050-12-31

Last updated

2023-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mullerian Anomaly of Cervix, Mullerian Anomaly of Uterus, Nec, Mullerian Anomaly of Vagina

Keywords

Mullerian anomaly, Diagnostic tools, Surgical treatment, Reproductive function, Obstetric complications

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 45 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* women without a uterus * aged \>45y

Design outcomes

Primary

Measure	Time frame	Description
Fertility	10 years after trying to conceive	Time to clinical pregnancy
Surgical approach	during surgery	Different surgical approaches used
Surgical success	15 years after surgery	Relief of symptoms after surgery

Secondary

Measure	Time frame	Description
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

Countries

Belgium

Contacts

Primary ContactEline Meireson

eline.meireson@uzgent.be093327817

Outcome results