NCT05415540

Brief Summary

This study aims to evaluate the global evolution of the quality of life on patients diagnosed with MRKH syndrome (Mayer-Rokitansky-Kuster-Hauser), 8 to 10 years after the first research.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 4, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2024

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

1.4 years

First QC Date

May 2, 2022

Last Update Submit

November 17, 2025

Conditions

Mrkh Syndrome

Keywords

Mayer-Rokitansky-Kuster-Hauser SyndromeQuality of lifeUtero-vaginal aplasia

Outcome Measures

Primary Outcomes (1)

  • Evaluation of global quality of life

    Evaluated by the World Health Organization Quality Of Life Brief Version (WHOQOL-BREF)

    Day 0

Secondary Outcomes (8)

  • Socio-professional integration

    Day 0

  • Socio-professional integration

    Day 0

  • Socio-professional integration

    Day 0

  • Sexual quality of life

    Day 0

  • Addictive behavioural disorders

    Day 0

  • +3 more secondary outcomes

Interventions

QuestionnairesOTHER

Subjects included in the study will answer questionnaires

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient who participated in the initial T1 psychological component of the previous study (MRKH protocol)

You may qualify if:

  • Patient aged of 18 years old or older
  • Patient who participated in the initial T1 psychological component of the previous study (MRKH protocol)

You may not qualify if:

  • \- Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker Children's Hospital

Paris, 75015, France

Location

MeSH Terms

Conditions

Mullerian aplasia

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Alaa CHEIKHELARD, Doctor

    PRINCIPAL INVESTIGATOR

  • Karinne Gueniche, MD, PhD

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2022

First Posted

June 13, 2022

Study Start

October 4, 2022

Primary Completion

February 27, 2024

Study Completion

February 27, 2024

Last Updated

November 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)