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Frozen hope: new study offers fertility option for rare condition

NCT ID NCT06518746

Disease control Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study is for people under 30 with disorders of sex development who are at risk of infertility or ovarian cancer. When they have surgery to remove their ovaries for medical reasons, a portion of the tissue will be frozen and stored. The goal is to see if this tissue can later be used to restore fertility or hormone function. The study will track how many samples survive freezing and whether patients find this approach acceptable.

What this could mean

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

Active substance
cryopreservation of gonadal tissue
What this could lead to
If successful, this could offer a way to preserve fertility and restore hormone function for patients with gonadal dysgenesis who otherwise have no options.
What could go wrong
This is an early-stage study with only 50 participants, and it is not yet known if the frozen tissue will actually restore fertility or hormone function. There is also a risk of adverse events from the procedure.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Jun 2031

An estimate. End dates often move.

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

Up to 30 years

Sex

Anyone

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: * \< 30 years of age * Individuals diagnosed with a disorder of sex development who have any risk for malignancy in their gonadal tissue and will have their gonads removed for a clinical indication * Individuals diagnosed with a disorder of sex development who are at risk of primary ovarian insufficiency (POI) due to an underlying genetic condition Exclusion Criteria: * Pregnancy * Patients likely to retain inherent fertility and reproductive function * Patients deemed high risk for perioperative complications * Patients 7-17 years of age unable to provide assent (i.e. significant psychiatric problems/cognitive delay) * Patients 18 and older unable to provide consent (i.e. significant psychiatric problems/cognitive delay)

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Conditions

The condition(s) this trial relates to.

gonadal dysgenesis ovarian cancer

As listed by the trial registrant

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

Ovarian cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

More trials for these conditions

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