Ovarian Tissue Cryopreservation

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Phoenix Children's Hospital
Study ID
NCT06710769
Status
Recruiting
Apply to this trial

Conditions

  • Infertility, Female

Eligibility Criteria

Sex
FEMALE
Age
1 Year - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Ovarian tissue removal will be performed laparoscopically — PROCEDURE
    under general anesthesia concomitantly with another scheduled procedure if possible. Following removal, ovarian tissue will be shipped to University of Pittsburg Medical Center, Magee-Womens Research Institute for processing. Freezing and storing techniques will be in accordance with FDA regulations for reproductive tissues, guidelines of the American Association of Tissues Banks and any other applicable federal, state and local regulations. The tissue will be carefully separated dividing the cortex from the medulla. The cortex will then be cryopreserved for long term storage. The medulla will be shipped overnight back to the PCH Department of Pathology for histological evaluation. If pathology finds evidence of cancer in the ovarian tissue provided, they may request that all of the patient's tissue be returned to pathology for a more detailed examination, which may eliminate the tissue available for the patient's future use.

Study Details

Ovarian Tissue Freezing For Fertility Preservation In Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen

Key Dates

Start date
Jul 30, 2020
Status verified
Jan 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: girls facing possible infertility
    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

Primary Outcome Measure

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. [ Time Frame: 10 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Phoenix ChildrensPhoenixArizona85016
Alexandra Walsh, MD
[email protected]
6029330916
Briana Fodor, BS
[email protected]
6029332548

Find similar trials in Phoenix, AZ

By research site
Phoenix Childrens· Phoenix, AZ

Related Studies