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Recruiting NCT07186764

NCT07186764 Evaluation of the Quality of Life and Gynecological Follow-up of Patients Treated for Mayer-Rokitansky-Küster-Hauser (MRKH) Syndrome

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Clinical Trial Summary
NCT ID NCT07186764
Status Recruiting
Phase
Sponsor University Hospital, Toulouse
Condition Mrkh Syndrome
Study Type OBSERVATIONAL
Enrollment 102 participants
Start Date 2026-03-04
Primary Completion 2027-03-04

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age 50 Years
Study Type OBSERVATIONAL
Interventions
QuestionnairesSemi-directed interview

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 102 participants in total. It began in 2026-03-04 with a primary completion date of 2027-03-04.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome affects 1 in 4,500 women and consists of utero-vaginal aplasia in 46 chromosom XX women, most often diagnosed in the presence of primary amenorrhea. This diagnosis, occurring in adolescence during the period of identity formation, can have significant psychological repercussions. This malformation can alter the body image and personal relationships of affected patients, beyond the impact on their sexual lives. Management around the disclosure is a crucial moment for these patients. Individual or group psychological support is systematically offered. Several international studies show that these patients experience a decline in their quality of life, and they are more anxious and depressed. Participation in support groups improves this state. The objective of this study is therefore to better understand Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome and the issues patients may face. For this reason, it seems essential to us to evaluate the overall quality of life, the quality of sexual life, the psychological state and the gynecological follow-up of women before or after treatment for vaginal aplasia.

Eligibility Criteria

Inclusion Criteria: * For Mayer-Rokitansky-Küster-Hauser patients: * Patient over 18 and under 50 * Confirmed diagnosis of Mayer-Rokitansky-Küster-Hauser syndrome * Diagnosis announced more than 1 year ago * Patient treated by the CRMR PGR * Patient affiliated with or benefiting from a social security scheme * Fluency in French * For the control population: * Patient over 18 and under 50 * Patient affiliated with or benefiting from a social security scheme * Fluency in French Exclusion Criteria: * For Mayer-Rokitansky-Küster-Hauser patients: * Minors over 50 years of age * Recent diagnosis \< 1 year * Other causes of uterine or vaginal aplasia, surgical or congenital • Patients benefiting from a legal protection measure (guardianship, curatorship, legal protection) * Patients unable to understand or answer the questionnaires * For the control population: * Minors over 50 years of age * Patients benefiting from a legal protection measure (guardianship, curatorship, legal protection) * Patients unable to understand or answer the questionnaires

Contact & Investigator

Central Contact

Audrey CARTAULT, MD

✉ cartault.a@chu-toulouse.fr

📞 05 67 77 11 29

Frequently Asked Questions

Who can join the NCT07186764 clinical trial?

This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Mrkh Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07186764 currently recruiting?

Yes, NCT07186764 is actively recruiting participants. Contact the research team at cartault.a@chu-toulouse.fr for enrollment information.

Where is the NCT07186764 trial being conducted?

This trial is being conducted at Toulouse, France.

Who is sponsoring the NCT07186764 clinical trial?

NCT07186764 is sponsored by University Hospital, Toulouse. The trial plans to enroll 102 participants.

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