Back to search results

Ovarian Tissue Cryopreservation for Pediatric Cancer Patients

This study is looking at safely removing and freezing ovarian tissue from young women (up to 30 years old) who have reached puberty and are facing medical treatments like chemotherapy, radiation, or surgery that could harm their fertility. The goal is to preserve their ability to have children and maintain hormone function in the future. The procedure involves laparoscopic surgery (a minimally invasive surgery using a small incision) to remove a piece of ovarian tissue. This tissue is then specially frozen using Ovarian Tissue Cryopreservation to protect the eggs. The study aims to see if this process can help preserve fertility and hormone function, with success measured at 3 months after the tissue is frozen. The study is currently observational and its status is unclear.

Study design
This is an observational study planning to enroll 250 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo laparoscopic surgery to remove ovarian tissue. The removed tissue will be stored and also used for research to improve storage methods.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, ovarian tissue freezing for fertility preservation, is measured at 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05309746

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

Recruiting
Not specifiedUp to 30Observational
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 Post-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen
Measured over 3 months

Conditions

Pediatric Cancer

Explore related trials

Childhood 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

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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)

What this trial measures

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

    Most of 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.