Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)

Description

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.

Conditions

Pediatric Cancer

Study Overview

Study Details

Study overview

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.

Ovarian Tissue Cryopreservation for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening Diagnosis or Treatment Regimen

Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)

Condition
Pediatric Cancer
Intervention / Treatment

-

Contacts and Locations

Chicago

Ann &Robert H Lurie Children's Hospital, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Patients with no anticipated oncologic therapies
  • * 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)

Ages Eligible for Study

to 30 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Erin Rowell,

Erin Rowell, MD, STUDY_DIRECTOR, Lurie Childrens Hospital

Study Record Dates

2035-01