Actively Recruiting

Age: 0 - 11Years
FEMALE
ID05299710

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

Led by Erin Rowell · Updated on 2024-11-18

250

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

Sponsors

E

Erin Rowell

Lead Sponsor

A

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to safely remove ovarian tissue in pre-pubertal girls who are at risk of infertility due to upcoming medical treatments such as chemotherapy, radiation, or surgery. The study focuses on preserving the ability to have children in the future by freezing ovarian tissue using a method called Ovarian Tissue Cryopreservation. The study also seeks to improve storage methods and techniques for restoring fertility and hormone function later on. The procedure involves a surgical method called laparoscopy to remove one ovary. This surgery is performed under general anesthesia and involves small cuts in the abdomen to access and remove the ovarian tissue. Before removal, both ovaries are examined to ensure they appear normal and free of masses. The removed tissue is then frozen for potential future use. This process is optional and separate from the child’s cancer treatment. Participants will have a pre-surgery assessment either in the hospital or outpatient clinics. Researchers will collect a small biopsy for research purposes before freezing the tissue. Participants are followed yearly through surveys for up to 20 years to monitor long-term outcomes. The main study outcome is evaluated at 3 months after tissue freezing, with ongoing follow-up to assess the restoration potential and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 11Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pre-pubertal individuals
  • Scheduled for surgery, chemotherapy, or radiation that may affect future fertility or hormone function, including certain doses of alkylating chemotherapy or radiation
  • Diagnosed with any health condition or cancer requiring removal of ovarian tissue or radiation impacting reproductive organs
  • Able to provide consent or assent
Not Eligible

You will not qualify if you...

  • Patients not expected to receive oncologic therapies
  • Post-pubertal individuals
  • Pregnant children
  • Children with only one ovary
  • Children at high risk for surgical complications
  • Patients unable to provide consent or assent due to psychiatric or cognitive issues

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 to 2 visits (in-person) for pre-surgery assessment at hospital or outpatient clinic

Surgery and Immediate Post-operative Care

Duration - Surgery lasts 30 to 65 minutes with immediate recovery period

Participants undergo laparoscopic surgery to remove ovarian tissue for cryopreservation under general anesthesia. The surgeon examines both ovaries before removal of one ovary.

1 surgical procedure visit (in-person) with post-operative monitoring

Long-term Monitoring

Duration - Yearly for up to 20 years

Participants are followed annually to evaluate long-term outcomes of ovarian tissue removal and potential restoration.

Annual follow-up visits (in-person or remote) for up to 20 years

Trial Site Locations

Total: 1 location

1

Ann & Robert H Lurie Childrens Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

S

Sara Reyes

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Frequently Asked Questions

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Published Research Related To This Trial

Infertility, infertility treatment, and achievement of pregnancy in female survivors of childhood cancer: a report from the Childhood Cancer Survivor Study cohort.

Sara E Barton, Julie S Najita, Elizabeth S Ginsburg...

https://pubmed.ncbi.nlm.nih.gov/23856401

Ovarian cryopreservation with transposition of a contralateral ovary: a combined approach for fertility preservation in women receiving pelvic radiation.

J Ryan Martin, Pinar Kodaman, Kutluk Oktay...

https://pubmed.ncbi.nlm.nih.gov/17084399

A new simple technique of laparoscopic temporary ovarian suspension in addition to ovarian cryopreservation for women prior to posterior pelvic radiation.

Roberto Paradisi, Raffaella Fabbri, Valentina Magnani...

https://pubmed.ncbi.nlm.nih.gov/20153882

Evidence-Based Recommendations for Fertility Preservation Options for Inclusion in Treatment Protocols for Pediatric and Adolescent Patients Diagnosed With Cancer.

Alison Fernbach, Barbara Lockart, Cheryl L Armus...

https://pubmed.ncbi.nlm.nih.gov/24799444

Fertility preservation in patients undergoing gonadotoxic therapy or gonadectomy: a committee opinion.

Practice Committee of American Society for Reproductive Medicine

https://pubmed.ncbi.nlm.nih.gov/24011612

Ovarian tissue cryopreservation for fertility preservation in cancer patients: successful establishment and feasibility of a multidisciplinary collaboration.

Clarisa R Gracia, Jeff Chang, Laxmi Kondapalli...

https://pubmed.ncbi.nlm.nih.gov/22466745