Infertile Females or Females With Ovarian Insufficiency
Conditions
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.
Interventions
PROCEDURETransplantation of previously cryopreserved ovarian tissu
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Thaw and surgical transplantation of previously collected cryopreserved ovarian cortical tissue
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy | 5 years |
| Return of menstrual function | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancer recurrence | 5 years | — |
| Surgical Complications of ovarian tissue transplantation | 5 years | Including infection, hospital readmission, re-operation |
| Acceptability | 5 years | — |
Countries
United States
Contacts
Primary ContactClarisa Gracia, MD
Outcome results
None listed