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RecruitingNCT04627818MULANUpdated Jul 30, 2026

Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies

An observational study in Mullerian Anomaly of Uterus, Nec, Mullerian Anomaly of Vagina and Mullerian Anomaly of Cervix, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to female participants aged Up to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by University Hospital, Ghent · Observational

From the registry’s dates

  • Started Jan 2021; still recruiting 5 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
Up to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Mullerian anomaly
  • Diagnostic tools
  • Surgical treatment
  • Reproductive function
  • Obstetric complications
03

In context

Enterocolitis, Necrotizing

228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.

Browse Enterocolitis, Necrotizing studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

diagnosed and/or treated in the Ghent University Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • women without a uterus
  • aged >45y
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients with a mullerian variation
06

What researchers measure

Primary outcomes

  1. Fertility

    Time to clinical pregnancy

    Time frame: 10 years after trying to conceive

  2. Fertility

    Early pregnancy loss

    Time frame: 18 weeks after conception

  3. Surgical approach

    Different surgical approaches used

    Time frame: During surgery

  4. Surgical success

    Relief of symptoms after surgery

    Time frame: 15 years after surgery

Secondary outcomes

  1. Diagnostic accuracy

    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

    Time frame: at the time of diagnostic workup

  2. Obstetric complications

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

    Time frame: 1 year after conception

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2021 (actual). Primary completion is estimated for Dec 2050, 359 months after the start.

Of 39 observational studies under Enterocolitis, Necrotizing, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 115. This study's planned 359 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2020
First posted
Nov 13, 2020
StartActual
Jan 1, 2021
Primary completionEst.
Dec 31, 2050
CompletionEst.
Dec 31, 2050
Last update
Jul 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04627818
Responsible party
Sponsor
First posted
Nov 13, 2020
Start date
Jan 1, 2021
Primary completion
Dec 31, 2050 (estimated)
Completion
Dec 31, 2050 (estimated)
Last update
Jul 30, 2026

Study contacts

Eline Meireson
Contact
eline.meireson@uzgent.be
093327817 ext. 0032
Tjalina Hamerlynck
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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