Freezing ovarian tissue for girls facing fertility threats from cancer treatment
Ovarian Tissue Freezing For Fertility Preservation In Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen
This study is testing if freezing ovarian tissue can help young girls with cancer keep their ability to have children after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 1 Year to 25 Years |
| Sex | Female |
| Sponsor | Phoenix Children's Hospital Academic / other |
| Drugs / interventions | cyclophosphamide, chemotherapy, radiation |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT06710769 on ClinicalTrials.gov |
What this trial studies
This study focuses on ovarian tissue cryopreservation as a method for fertility preservation in young females diagnosed with cancer or other conditions that may threaten their reproductive capacity. The intervention involves laparoscopic removal of ovarian tissue, which can be frozen for future use, allowing patients to maintain their fertility after undergoing potentially damaging treatments like chemotherapy or radiation. The study aims to address the psychosocial and biological implications of infertility in female cancer survivors, ensuring they are informed about their options for preserving fertility before treatment begins.
Who should consider this trial
Good fit: Ideal candidates for this study are young females diagnosed with malignancies that require treatments known to affect fertility, such as certain chemotherapy regimens or radiation.
Not a fit: Patients who are currently pregnant, breastfeeding, or those who are eligible for oocyte preservation may not benefit from this specific intervention.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the fertility preservation options available to young female cancer patients.
How similar studies have performed: Previous studies have shown success with similar fertility preservation techniques, indicating a promising approach for young cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed or relapsed malignancy with proposed treatment regimen containing at least ONE (1) of the following: whole abdomen or pelvic irradiation total body irradiation Proposed treatment regimen to include any of the following: cyclophosphamide equivalent dose (CED, see Green et al 2014) ≥7.5 g/m2 any treatment regimen containing procarbazine bone marrow transplant conditioning regimen containing alkylators OR health condition or malignancy that requires removal of one or both ovaries. Health status adequate to undergo elective laparoscopic surgery (as per anesthesiologist assessment) Exclusion Criteria: * Pregnancy or a patient who is currently breastfeeding Patients who are eligible for and agree to oocyte preservation Anyone deemed high risk for complications from the surgery and/or anesthesia. Anyone unable to provide consent due to psychiatric conditions or cognitive delay (in parent/guardian for patients \<18 years, and patient \>18 years)
Where this trial is running
Phoenix, Arizona
- Phoenix Childrens — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Study coordinator: Alexandra Walsh, MD
- Email: awalsh@phoenixchildrens.com
- Phone: 602-933-4483
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.