Study Stopped
This treatment is now considered standard of care
Ovarian Freezing Before Cancer Treatment
Ovarian Tissue Freezing Prior to Chemotherapy or Radiation Therapy: a Study by the Oncofertility Consortium
1 other identifier
observational
31
1 country
1
Brief Summary
Women of reproductive age who will undergo cancer treatment may participate in a study to surgically remove ovarian tissue and store it, frozen, for their potential use in the future. 20% of collected tissue will be used for research.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2007
CompletedFirst Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedApril 15, 2021
April 1, 2021
12.8 years
January 26, 2010
April 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Follicular development in vitro
Several factors, including 3-dimensional biogel scaffolds,growth factors, hormones and other culture conditions, will be investigated as they relate to successful maturation of immature follicles obtained from ovarian tissue.
5 years
Eligibility Criteria
cancer patients
You may qualify if:
- Female patient between the ages of 18 and 42 years.
- In need of imminent cancer treatment, including surgery, chemotherapy or radiation therapy, which is viewed as likely to result in a permanent and complete loss of subsequent ovarian function or have a health condition that will result in premature ovarian failure. These include, but are not limited to: abdominopelvic irradiation, total body irradiation, alkylating-intensive chemotherapy, and removal of ovaries as part of their cancer treatment.
- Reasonably good health.
- Two ovaries.
- Able to defer definitive cancer therapy for approximately 3 days until the patient recovers from laparoscopic oophorectomy.
You may not qualify if:
- Patients considered as high risk for surgical complications will be excluded from the research protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn Fertility Care, 3701 Market Street, Suite 800
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
Gracia CR, Chang J, Kondapalli L, Prewitt M, Carlson CA, Mattei P, Jeffers S, Ginsberg JP. Ovarian tissue cryopreservation for fertility preservation in cancer patients: successful establishment and feasibility of a multidisciplinary collaboration. J Assist Reprod Genet. 2012 Jun;29(6):495-502. doi: 10.1007/s10815-012-9753-7. Epub 2012 Apr 1.
PMID: 22466745BACKGROUND
Biospecimen
ovarian tissue
Study Officials
- PRINCIPAL INVESTIGATOR
Clarisa Gracia, MD, MSCE
University of Pennsylvania
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2010
First Posted
January 27, 2010
Study Start
June 12, 2007
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
April 15, 2021
Record last verified: 2021-04