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

NCT05299710 | Recruiting

• 1 other identifier: 2018-1509
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

OTC, fertility

Outcome Measures

Primary Outcomes (1)

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

  Most of the surgically removed tissue will be stored for the child's future use. Participants have the option of donating for research purposes a small piece of the ovarian tissue, a small amount of the child's blood and the media used to process the ovarian tissue (which is otherwise discarded, for research which evaluates optimizing ovarian cryopreservation and fertility restoration techniques

  3 months

Secondary Outcomes (1)

• Annual follow-up for patients who undergo ovarian tissue cyropreservation

  yearly for up to 20 years

Study Arms (1)

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.

Procedure: Laparoscopic surgery

Interventions

Laparoscopic surgery PROCEDURE

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.

Ovarian Tissue Cryopreservation

Eligibility Criteria

• Age: Up to 11 Years
• Gender Eligibility Details: natal females
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Natal females who have not yet gone through puberty and who face a significant risk of infertility from their medical diagnosis or treatment

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Erin Rowell: lead
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (1)

Ann & Robert H Lurie Childrens Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (32)

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• Wenliang Chen.

  BACKGROUND

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MeSH Terms

Conditions

Neoplasms; Ornithine Carbamoyltransferase Deficiency Disease

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Erin Rowell, MD

  Lurie Childrens Hospital

  STUDY DIRECTOR

Central Study Contacts

Sara Reyes

CONTACT

312-227-4145; FertilityPreservation@luriechildrens.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of FHPR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: March 29, 2022
• Study Start: May 29, 2018
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): January 1, 2035
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

US (1)