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CompletedNCT01911884MRKHUpdated Sep 5, 2025

Assessment of Quality of Global and Sexual Life and Impact of Surgical and Non Surgical Vaginal Aplasia in Patients With a Rokitansky Syndrome

An interventional study of evaluate quality of life of surgical and non surgical vaginal aplasia in Rokitansky Syndrome and Surgical or Vaginal Dilatation of Vaginal Aplasia, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Oct 2012, registered Jul 2013).

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Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

The principal objective is to assess the general health status and the sexual health status of women with Rokitansky syndrome having received a surgical or non surgical treatment.

The secondary purpose is to assess the anatomical aspect and the quality of sexual life. To search a correlation between the anatomical result, the general and sexual quality of life. To compare the different techniques of medical follow-up in terms of anatomic results, general quality of life, sexual quality of life, complications and morbidities.

To evaluate social inclusion of these women with their family situation, social and professional category and their job.

At the same time, we propose an evaluation with a psychologist to study the impact of the announcement of the diagnosis. This impact study is conducted at a distance from diagnosis.

Read the detailed description

The MRKH syndrome is a congenital disorder characterized by absence of uterus and at least the two thirds of the vagina, a female phenotype and a normal karyotype XX.

These patients have normal ovaries and fallopian tubes. The external genitalia are normal. This syndrome was described by Mayer (1829), Rokitansky ( 1838), Kuster ( 1910) and Hauser ( 1961). About one in every 4500 female babies has this condition. This syndrome represents 85% of congenital vagina aplasia and is the second cause of primary amenorrhea after disorders of sexual development. These women are unfertile.

The malformation can be isolated or associated with other malformations called MURCS (Müllerian duct aplasia, renal aplasia, and cervicothoracic somite dysplasia), as kidney ( 30%), bone ( 10%) or cardiac malformations ( 1%).

The most common age for MRKH to be diagnosed is when the woman hasn't started her period ( 85%).Some girls may find out at an earlier age when there is a severe malformation , during a systematic gynaecological examination or during an pelvic ultrasound. When the women are older, the syndrome can be diagnosed during studies for infertility.

A pelvic ultrasound is usually the first test performed to assess presence of uterus. A magnetic resonance imaging may be used to complete the investigations. These tests can also confirm if there are two ovaries and two kidneys. Sometimes, a very small uterus can be seen, it's a uterine horn.

The psychological management is essential to take care of the women affected.It seeks to understand the impact of the diagnosis announcement and the various treatments offered. The follow-up can be different for each girl and her parents during several appointments.

Therapeutic management can be proposed when the girl is ready because the therapeutic is long and difficult. Two therapeutic approaches can be proposed: to create a vagina using dilators or having a surgical procedure. In France, vaginal reconstruction with dilators is the most used. This method consists in dilating the vagina progressively with different sizes of dilators in order to obtain a vaginal opening of 8 cm around 6 months after treatment initiation. This method is successful in about 75% of cases. Complications are exceptional.

Surgery is an option for patients who are unsuccessful with dilatators or patients who prefer surgery. A number of operations are appropriate for the correction of vaginal agenesis. Vecchietti procedure and sigmoid vaginoplasty are the most commonly used techniques in France.

In national and international publications, it is impossible to compare scientifically the results of the different technique because of the small effective in each studies and because of the the lack of standardized assessment. Studies report the functional result for each technique but none compare the techniques used. No studies compared the result in terms of anatomical and function results, complications and quality of life.

The demonstration of a positive correlation between the anatomic criteria and the functional results would help to guide the surgical technique. The lack of correlation would suggest that a perfect anatomical reconstruction is not essential. If it is demonstrated, the management should focus on other criteria like psychological management. Several factors seem to influence the general and sexual quality of life of women affected by the Rokitansky syndrome. Our objective is to evaluate the importance of these factors to improve the treatment of these women.

02

Conditions studied

  • Rokitansky Syndrome
  • Surgical or Vaginal Dilatation of Vaginal Aplasia

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Keywords

  • Rokitansky syndrome
  • surgical or vaginal dilatation of vaginal aplasia
  • quality of global and sexual life
03

In context

Mullerian aplasia

20 studies on the registry are indexed under Mullerian aplasia; 11 are open to participants now.

This study's enrollment of 138 is above the median of 20 across 13 interventional studies indexed under Mullerian aplasia.

Browse Mullerian aplasia studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

  • Patient affected with Rokitansky syndrome
  • Patient over 18 years old
  • Patient care with dilatations or by surgery since 1995
  • Patient having started dilatations or having had surgery since at least one year
  • Patient who signed the consent
  • French patient
  • Women with social welfare

Exclusion criteria

Exclusion Criteria:

  • Patient with a serious chronic disease interfering with analysis to be performed in this project.
  • Patient can't reading or writing
  • Patient with legal protection
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
138 participants (actual)

Study arms

  • Other
    Patients with a Rokitansky Syndrome

    Patients with a Rokitansky Syndrome

    Behavioral: evaluate quality of life of surgical and non surgical vaginal aplasia

Interventions

  • Behavioralevaluate quality of life of surgical and non surgical vaginal aplasia

    protocol designed to evaluate quality of life of surgical and non surgical vaginal aplasia

06

What researchers measure

Primary outcomes

  1. Assessment of quality of global life

    To fill a self-administered questionnaire: the World Health Organization Quality Of Life (general scale WHOQOL)

    Time frame: Day 0

Secondary outcomes

  1. Assessment of quality of sexual life

    To fill 2 self-administered questionnaires : Female Sexual Function Index and Female Sexual Dysfunction Scale-Revised (FSFI and FSDS)

    Time frame: Day 0

  2. Assessment of anatomic results

    Gynaecological examination

    Time frame: Day 0

  3. Assessment of social integration

    To fill a self-administered questionnaire (marital status, occupational group, education level, employment status)

    Time frame: Day 0

07

Study locations

1 site
  • Service d'Endocrinologie et Gynécologie Pédiatriques Hôpital Necker Enfants Malades
    Paris, 75015, France
08

References and documents

Publications

  • Cheikhelard A, Bidet M, Baptiste A, Viaud M, Fagot C, Khen-Dunlop N, Louis-Sylvestre C, Sarnacki S, Touraine P, Elie C, Aigrain Y, Polak M; French MRKH Study Group. Surgery is not superior to dilation for the management of vaginal agenesis in Mayer-Rokitansky-Kuster-Hauser syndrome: a multicenter comparative observational study in 131 patients. Am J Obstet Gynecol. 2018 Sep;219(3):281.e1-281.e9. doi: 10.1016/j.ajog.2018.07.015. Epub 2018 Jul 21. PubMed 30036500 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2012 to primary completion in Apr 2015, 29 months.

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

Registered
Jul 26, 2013
First posted
Jul 30, 2013
StartActual
Oct 11, 2012
Primary completionActual
Apr 10, 2015
CompletionActual
Apr 10, 2015
Last update
Sep 5, 2025
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 Sep 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01911884
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Jul 30, 2013
Start date
Oct 11, 2012
Primary completion
Apr 10, 2015
Completion
Apr 10, 2015
Last update
Sep 5, 2025

Study contacts

Michel POLAK, PUPH
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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