Freezing ovarian tissue in young girls at risk of infertility

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 safe removal and cryopreservation of ovarian tissue in pre-pubertal girls who are about to undergo treatments like chemotherapy or radiation that may lead to infertility. The procedure involves laparoscopic surgery to extract ovarian tissue, which is then frozen using a specialized method to preserve its viability for future use. Additionally, a small biopsy of the ovarian tissue will be collected for research purposes to improve storage techniques and enhance future fertility restoration methods. The goal is to provide these young patients with the option to restore their fertility and hormone function later in life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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)

Where it's running

• Ann & Robert H Lurie Childrens 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.