NCT06710769

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
63mo left

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Jul 2020Jul 2031

Study Start

First participant enrolled

July 30, 2020

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2023

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

9.9 years

First QC Date

November 6, 2023

Last Update Submit

January 22, 2026

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • 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.

    data will be investigated via qualitative analysis.

    10 years

Study Arms (1)

girls facing possible infertility

OTHER

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

Procedure: Ovarian tissue removal will be performed laparoscopically

Interventions

Ovarian tissue removal will be performed laparoscopicallyPROCEDURE

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.

girls facing possible infertility

Eligibility Criteria

Age1 Year - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients who are facing a fertility threatening diagnosis and/or treatment
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Newly diagnosed or relapsed malignancy 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 alkylators
  • OR health condition or malignancy that requires removal of one or both ovaries. Health status adequate to undergo elective laparoscopic surgery (as per anesthesiologist assessment)

You may not qualify if:

  • Pregnancy or a patient who is currently breastfeeding
  • Patients who are eligible for and agree to oocyte preservation
  • Anyone deemed high risk for complications from the surgery and/or anesthesia.
  • Anyone unable to provide consent due to psychiatric conditions or cognitive delay (in parent/guardian for patients \<18 years, and patient \>18 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phoenix Childrens

Phoenix, Arizona, 85016, United States

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Central Study Contacts

Alexandra Walsh, MD

CONTACT

602-933-4483awalsh@phoenixchildrens.com

Briana Fodor

CONTACT

602-933-4483bfodor@phoenixchildrens.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This study is an investigation of the characteristics of patients who utilize ovarian tissue cryopreservation, the timing of ovarian tissue use, and pregnancy outcomes.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 29, 2024

Study Start

July 30, 2020

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2031

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

US(1)