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

Description

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.

Conditions

Cancers

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Study Overview

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Study Details

Study overview

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.

Ovarian Tissue Freezing for Fertility Preservation in Pre-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen

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

Condition
Cancers
Intervention / Treatment

-

Contacts and Locations

Chicago

Ann & Robert H Lurie Childrens 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

  • * 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)
  • * 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)

Ages Eligible for Study

to 11 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