Ovarian Freezing Before Cancer Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01057745
First received: January 26, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

Women of reproductive age that will undergo cancer treatment may participate in a study to preserve ovarian tissue. Participants undergo surgical removal of ovarian tissue. Eighty percent of the tissue frozen and stored for the patient's future use. Twenty percent of the tissue is used for research purposes-studies conducted to determine if the eggs can be matured in the laboratory.


Condition
Woman Who Will be Undergoing Chemotherapy
Woman Who Will be Undergoing Radiation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ovarian Tissue Freezing Prior to Chemotherapy or Radiation Therapy: a Study by the Oncofertility Consortium

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Estimated Enrollment: 150
Study Start Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

cancer patients

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients considered as high risk for surgical complications will be excluded from the research protocol.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Clarisa R. Gracia, MD, MSCE, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01057745     History of Changes
Other Study ID Numbers: 806062
Study First Received: January 26, 2010
Last Updated: January 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
woman
chemotherapy
radiation

ClinicalTrials.gov processed this record on April 16, 2014