Recruiting

OTC-Pre Pubertal

Sponsor:

Erin Rowell

Code:

NCT05299710

Conditions

Cancers

Eligibility Criteria

Sex: Female

Age: 0 - 11

Healthy Volunteers: Not accepted

Interventions

Laparoscopic surgery

Study Details

Brief summary:

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

Study ID

NCT05299710

Start date

May 29, 2018

Status verified date

Sep, 2026

Completion date

Jan, 2035

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0 - 11

Healthy Volunteers: Not accepted

Inclusion 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)

Exclusion Criteria:

  • 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)

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Ovarian Tissue Cryopreservation

Children faced with a fertility threatening diagnosis will be offered ovarian tissue cryopreservation.Pre-surgery assessment will be done while your child is in the hospital or in the pediatric oncology, surgery, or anesthesia clinic as an outpatient. The surgical procedure used to remove your child's ovary is called laparoscopy. It is not required for the treatment of your child's cancer. Laparoscopic surgery is done under general anesthesia (your child will be asleep during the surgery) in the operating room.

Interventions

Laparoscopic surgery

Surgery used to remove your child's ovary tissue is called laparoscopic surgery. Laparoscopic surgery employs a telescope-like instrument called laparoscope. The laparoscope will be put into your child's belly through a small (about half an inch) cut just below the belly button. Two or three other cuts may be made to allow for other instruments to help remove one of the ovaries. The surgeon will then look at both ovaries before the removal of one. Both of your child's ovaries must appear normal and be free of any masses in order to complete the surgery. The surgeon will choose which ovary will be removed at the time of surgery. This type of surgery is likely to last for 30 to 65 minutes.

Primary outcome measure

  • Ovarian Tissue Freezing for Fertility Preservation in Pre-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Sara Reyes

312-227-4145FertilityPreservation@luriechildrens.org

Locations

Ann & Robert H Lurie Childrens Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Sara Reyes

312-227-4145

More Information

Sponsor

Erin Rowell

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • OTC, fertility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Erin Rowell on 2026-09-03.