Autologous Ovarian Tissue Transplantation
University of Pittsburgh
Summary
Chemotherapy and radiation for cancer and other conditions can cause infertility. Several centers around the world are cryopreserving ovarian tissue from these patients though an experimental protocol, including the Fertility Preservation Program in Pittsburgh (protocol PRO08050491). The objective of this study is to study the efficacy and safety of autologous tissue transplantation in patients diagnosed with primary ovarian insufficiency after chemotherapy and/or radiation treatments.
Description
This investigation involves patient enrollment, thaw and surgical transplantation of previously collected cryopreserved ovarian cortical tissue, a series of follow-up assessments during the first 2 years after transplantation and an annual survey after year 2. Screening visit (standard fertility consultation): 1. The subject will complete a medical and reproductive history to document menstrual function and suitability for pregnancy. 2. The subject will have standard fertility testing (including but not limited to serum Follicle Stimulating Hormone (FSH), Estradiol (E2), and Anti-Mullerian H…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Previously cryopreserved ovarian tissue * Ovarian insufficiency and/or candidate for pregnancy * Good health * Oncologist's clearance Exclusion Criteria: * Patients considered to be high risk for surgical complications * Women with contraindication for pregnancy if goal is to achieve pregnancy * Women positive for the BRCA mutations * Women with a history of leukemia, ovarian cancer or a cancer that likely involved ovaries at the time of ovarian tissue collection * Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent *…
Interventions
- ProcedureOvarian tissue transplant
Pieces of previously frozen ovarian cortex will be put in the abdomen laparoscopically, or with mini laparotomy
Location
- Magee-Womens HospitalPittsburgh, Pennsylvania