NCT05309746Recruiting
Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)
Ovarian Tissue Cryopreservation for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening 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 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
- 1 Nov 2017
- Primary completion date
- Dec 2030
- Lead sponsor
- Erin Rowell
- Diseases
- Childhood cancers
- NCT number
- NCT05309746
What you commit to
- Study type: Observational
- Planned participants: 250
- From 1 Nov 2017 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
- Pregnant children
- Children with one ovary
- Children deemed high risk for perioperative complications
Who the study is looking for
- 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.
Age in the registry: - to 30 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ann & Robert H. Lurie Children's 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.