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Can freezing ovarian tissue protect fertility in children facing cancer treatment?

NCT ID NCT05309746

Disease control Sponsor: Erin Rowell Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests a procedure to remove and freeze ovarian tissue from children and young adults under 30 who face treatments that may harm their fertility, such as chemotherapy, radiation, or surgery. The goal is to store the tissue for future use to restore fertility and hormone function. Participants undergo laparoscopic surgery to remove one ovary, and researchers follow up yearly to check ovarian function. The study also allows optional donation of a small tissue piece for research to improve freezing and restoration techniques.

What this could mean

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

Active substance
Laparoscopic surgery to remove and freeze ovarian tissue
What this could lead to
If successful, this approach could help children who face fertility-threatening treatments preserve the chance to have biological children and restore hormone function later in life.
What could go wrong
The procedure is surgical and carries risks like bleeding or infection. Freezing and future use of the tissue may not always restore fertility, and long-term success is still being studied.

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.

Participants

About 250 people

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

Started

Nov 2017

Expected to finish

Jan 2035

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.

Who is studied

Natal females who have gone through puberty and who face a significant risk of infertility from their medical diagnosis or treatment

Ages

Up to 30 years

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: * Post-pubertal individuals \< 30 years of age * Will undergo imminent surgery, chemotherapy or radiation therapy that has implications on future fertility and reproductive hormone potential: any health condition or malignancy that requires removal of all or part of one or both ovaries, whole abdomen or pelvic irradiation≥ 10Gy in post-pubertal girls or ≥15 Gy in pre- pubertal girls * total body irradiation, and * alkylating-intensive chemotherapy * cyclophosphamide cumulative dose ≥7.5 g/m2 * any treatment regimen containing procarbazine * busulfan cumulative dose \>600 mg/m2 * alkylating chemotherapy conditioning prior to stem cell transplantation * combination of any alkylating agent with total body irradiation or whole abdomen or pelvic radiation * cranial radiation ≥30 Gy * summed alkylating agent dose score ≥3 (Green et al., 2009) * cyclophosphamide equivalent dose (CED) ≥ 4,000 mg/m2 (Green et al., 2014) * Patients may have newly diagnosed or relapsed disease. Those who were not enrolled at diagnosis are eligible even if they have received therapy that is viewed as likely to result in complete and permanent loss of ovarian function. However, these patients will be required to provide a 4mm punch biopsy of their tissue for research. Exclusion Criteria: * Patients with no anticipated oncologic therapies * Pregnant children * Children with one ovary * Children deemed high risk for perioperative complications * Patients unable to provide consent/assent (i.e. significant psychiatric problems/cognitive delay)

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Conditions

The condition(s) this trial relates to.

childhood malignant neoplasm neoplasm

As listed by the trial registrant

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

Pediatric cancer

How to take part

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  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

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Contacts and locations

Locations

  • Ann &Robert H Lurie Children's Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

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