Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue

Abramson Cancer Center at Penn Medicine1 site in 1 country10 target enrollmentJune 1, 2013

ConditionsInfertile Females or Females With Ovarian Insufficiency

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infertile Females or Females With Ovarian Insufficiency
Sponsor: Abramson Cancer Center at Penn Medicine
Enrollment: 10
Locations: 1
Primary Endpoint: Return of menstrual function
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility. Ovarian tissue cryopreservation is an experimental strategy offered at The University of Pennsylvania to preserve future fertility (protocol 806062). The primary objective of this study is to determine the efficacy and safety of autologous transplantation of previously cryopreserved ovarian cortical tissue in patients who experience infertility or ovarian insufficiency after cancer treatments.

Registry

clinicaltrials.gov

Start Date

June 1, 2013

End Date

December 1, 2028

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Abramson Cancer Center at Penn Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female patient between the ages of 18 and 45 years
•Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation
•Ovarian insufficiency defined as an elevated FSH over 10
•Inability to conceive after 6 months of unprotected intercourse with male
•Reasonably good health
•Candidate for pregnancy
•Written clearance for the procedure from the patients oncologist

Exclusion Criteria

•Patients considered to be high risk for surgical complications will be excluded from the research protocol
•Women who are known to be positive for the BRCA mutation
•Women with a history of leukemia, ovarian cancer or a cancer that likely involved the ovaries at the time of ovarian tissue collection
•Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
•Current pregnancy