NCT05299710Recruiting
Ovarian Tissue Cryopreservation in Pre-Pubertal (OTC-Pre Pubertal)
Ovarian Tissue Freezing for Fertility Preservation in Pre-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
The purpose of this study is to safely remove ovarian tissue in pre-pubertal pediatric patients, who are at risk for infertility from their medical treatment, for freezing for future restoration of fertility and hormone function.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 28 Aug 2020
- Start date
- 29 May 2018
- Primary completion date
- Dec 2030
- Lead sponsor
- Erin Rowell
- Diseases
- Childhood cancers
- NCT number
- NCT05299710
What you commit to
- Study type: Observational
- Planned participants: 250
- From 29 May 2018 to the primary completion date, Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with no anticipated oncologic therapies
Other illness
- Patients unable to provide consent/assent (i.e. significant psychiatric problems/cognitive delay)
Other
- Post-pubertal individuals
- Pregnant children
- Children with one ovary
- Children deemed high risk for perioperative complications
Who the study is looking for
- 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)
Age in the registry: - to 11 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ann & Robert H Lurie Childrens Hospital Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.