Ovarian Tissue Cryopreservation for Female Infertility (OTC Trial)

N/A

Recruiting

Research Sponsored by Phoenix Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed or relapsed malignancy with proposed treatment regimen containing at least ONE of the following: whole abdomen or pelvic irradiation, total body irradiation

Proposed treatment regimen to include any of the following: cyclophosphamide equivalent dose (CED, see Green et al 2014) ≥7.5 g/m2, any treatment regimen containing procarbazine, bone marrow transplant conditioning regimen containing alkylators

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is about freezing ovarian tissue to help young girls facing medical conditions that may affect their future fertility.

Who is the study for?

This trial is for girls who may lose their fertility due to medical treatments like high-dose chemotherapy or pelvic irradiation, and those needing ovary removal due to health conditions. They must be healthy enough for laparoscopic surgery as determined by an anesthesiologist.

What is being tested?

The study involves the laparoscopic removal of ovarian tissue before starting a treatment that could cause infertility. The removed tissue is then frozen for potential future use in restoring fertility.

What are the potential side effects?

Possible side effects include typical surgical risks such as pain, bleeding, infection at the incision site, and general anesthesia-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer treatment includes whole abdomen, pelvic, or total body irradiation.

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My treatment plan includes high-dose chemotherapy or a bone marrow transplant.

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I need surgery to remove one or both ovaries and am healthy enough for surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of patients who utilize their ovarian tissue and the age at which they use it will be evaluated. The number of patients who elect to have OTC will be analyzed over time to identify trends.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: girls facing possible infertilityExperimental Treatment1 Intervention

Newly diagnosed female or relapsed malignancy who is 1-25 years of age with proposed treatment regimen containing at least ONE (1) of the following: whole abdomen or pelvic irradiation total body irradiation Proposed treatment regimen to include any of the following: cyclophosphamide equivalent dose (CED, see Green et al 2014) ≥7.5 g/m2 any treatment regimen containing procarbazine bone marrow transplant conditioning regimen containing alkylator OR health condition or malignancy that requires removal of one or both ovaries

0 / 3Eligibility criteria met