RecruitingNCT07186764

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

Evaluation of the Overall Quality of Life and Gynecological Follow-up of Patients Treated for Mayer-Rokitansky-Küster-Hauser (MRKH) Syndrome at the Toulouse University Hospital


Sponsor

University Hospital, Toulouse

Enrollment

102 participants

Start Date

Mar 4, 2026

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria11

  • 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 Criteria10

  • 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

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Interventions

OTHERQuestionnaires

questionnaires: WHOQOL-BREF (Quality of Life Study Questionnaire), FSFI (Female Sexual Function Index), FSDS-R (The Femala sexual distress scale-revised), Rosenberg scale (self-esteem assessment)

OTHERSemi-directed interview

Semi-directed interview on the treatment pathway and the impact of utero-vaginal aplasia on intimate and personal life


Locations(1)

Service d'Endocrino-gynéco-pédiatrie, Hôpital des Enfants, 330 Avenue de Grande Bretagne

Toulouse, France

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NCT07186764