Freezing ovarian tissue to preserve fertility in young cancer patients

Ovarian Tissue Cryopreservation for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening Diagnosis or Treatment Regimen

This study is testing whether freezing ovarian tissue can help young cancer patients preserve their fertility for the future after they undergo treatments like chemotherapy or radiation.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: N/A to 30 Years
• Sex: Female
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago (Academic / other)
• Drugs / interventions: chemotherapy, radiation, cyclophosphamide
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT05309746 on ClinicalTrials.gov

What this trial studies

This study focuses on the removal and cryopreservation of ovarian tissue in post-pubertal pediatric patients who are at risk of infertility due to cancer treatments such as chemotherapy, radiation, or surgery. The aim is to safely store the ovarian tissue for future use, allowing for the potential restoration of fertility and hormone function. Participants will undergo laparoscopic surgery to remove a portion of their ovarian tissue, which will be frozen using a specialized method to prevent damage. Additionally, a small biopsy of the ovarian tissue will be collected for research purposes to improve storage techniques and outcomes.

Who should consider this trial

Good fit: Ideal candidates are post-pubertal individuals under 30 years old who are about to undergo treatments that may affect their fertility.

Not a fit: Patients who are not undergoing treatments that pose a risk to their fertility may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help preserve fertility options for young cancer survivors in the future.

How similar studies have performed: Other studies have shown promise in ovarian tissue cryopreservation, indicating potential success for this approach.

Eligibility criteria

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)

Where this trial is running

Chicago, Illinois

• Ann &Robert H Lurie Children's Hospital — Chicago, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Sara Reyes

Conditions Pediatric Cancer; OTC; fertility