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Ovarian Tissue Cryopreservation for Fertility Preservation in Pre-Pubertal Children

This study is for girls aged 11 and younger who are facing medical treatments like chemotherapy, radiation, or surgery that could make them infertile (unable to have children) in the future. The study aims to safely remove and freeze a small piece of ovarian tissue using a procedure called laparoscopic surgery. This frozen tissue can then be used later to help restore fertility and hormone function. Researchers want to see if this process, called Ovarian Tissue Cryopreservation, can successfully preserve your child's ability to have children. The main goal is to measure the success of freezing the ovarian tissue for future use, which will be assessed after 3 months. The study is currently recruiting 250 participants.

Study design
This is an observational study involving 250 pre-pubertal female participants. It is not a randomized study, meaning there is no comparison group receiving a different treatment.
What's involved
Participants will undergo laparoscopic surgery to remove ovarian tissue. The removed tissue will then be stored using a special freezing method.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of successful ovarian tissue freezing for fertility preservation will be measured at 3 months.

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NCT05299710

Ovarian Tissue Cryopreservation in Pre-Pubertal (OTC-Pre Pubertal)

Recruiting
Not specifiedUp to 11Observational
Erin Rowell
~250 participants
Updated 2024-11-18 on ClinicalTrials.gov
What's tested:Laparoscopic surgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ovarian Tissue Freezing for Fertility Preservation in Pre-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen
Measured over 3 months

Conditions

Cancers

Explore related trials

Malignant Neoplasm

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Erin Rowell, MD · STUDY_DIRECTOR · Lurie Childrens Hospital

Who to contact

Sara Reyes
[email protected]
312-227-4145
Email the study team

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Eligibility criteria

Inclusion

Pre- Pubertal Individual
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 ≥15Gy 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)

Exclusion

Patients with no anticipated oncologic therapies
Post-pubertal individuals
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)

What this trial measures

  • Ovarian Tissue Freezing for Fertility Preservation in Pre-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen3 months

    Most of the surgically removed tissue will be stored for the child's future use. Participants have the option of donating for research purposes a small piece of the ovarian tissue, a small amount of the child's blood and the media used to process the ovarian tissue (which is otherwise discarded, for research which evaluates optimizing ovarian cryopreservation and fertility restoration techniques