Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Recruiting
NCT Number: NCT01870752
Ovarian Tissue Transplantation
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Transplantation of previously cryopreserved ovarian tissu
ProcedurePrimary outcomes
-
Pregnancy
Time frame: 5 years
-
Return of menstrual function
Time frame: 5 years
Secondary outcomes
-
Cancer recurrence
Time frame: 5 years
-
Surgical Complications of ovarian tissue transplantation
Time frame: 5 years
Including infection, hospital readmission, re-operation
-
Acceptability
Time frame: 5 years
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Abramson Cancer Center at Penn Medicine
Other
Registry information
Official study title
Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue
Important dates
- Study start
- 2013
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Jun 6, 2013
- Registry last updated
- Sep 10, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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