Freezing ovarian tissue to preserve fertility in young cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Sara Reyes
• Email: FertilityPreservation@luriechildrens.org
• Phone: 312-227-4145

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.