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Study explores life quality after vaginal aplasia treatments

NCT ID NCT01911884

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study looked at 138 women with Rokitansky syndrome, a condition where the vagina and uterus are underdeveloped. Researchers compared quality of life and sexual health in women who had surgery versus those who used vaginal dilation. The goal was to see which approach leads to better overall well-being and social integration.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors understand which treatments (surgery or dilation) lead to better quality of life and sexual health for women with Rokitansky syndrome.
What could go wrong
This is an observational study that does not test a new treatment. It only measures outcomes after the fact, so it cannot prove which treatment is best.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

138 people

The number who actually took part.

Started

Oct 2012

Finished

Apr 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * 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

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Conditions

The condition(s) this trial relates to.

Mayer-Rokitansky-Kuster-Hauser syndrome mullerian aplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rokitansky syndrome Surgical or vaginal dilatation of vaginal aplasia

Contacts and locations

Locations

  • Service d'Endocrinologie et Gynécologie Pédiatriques Hôpital Necker Enfants Malades

    Paris, 75015, France