Freezing ovarian tissue in young girls at risk of infertility
Ovarian Tissue Freezing for Fertility Preservation in Pre-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen
This study is testing if freezing ovarian tissue from young girls before they start cancer treatments can help them have babies later in life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | N/A to 11 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 | NCT05299710 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pre-pubertal girls who are about to undergo surgery, chemotherapy, or radiation therapy that may affect their ovarian function.
Not a fit: Patients who do not require oncologic therapies or are post-pubertal will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help preserve fertility in young girls who are at risk of infertility due to cancer treatments.
How similar studies have performed: Other studies have shown promise in ovarian tissue cryopreservation, indicating that this approach may be effective in preserving fertility.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.