Ovarian Freezing Before Cancer Treatment

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Clarisa Gracia, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01057745
First received: January 26, 2010
Last updated: March 17, 2015
Last verified: March 2015
  Purpose

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.


Condition
Effects of Chemotherapy

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

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Follicular development in vitro [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

ovarian tissue


Estimated Enrollment: 150
Study Start Date: February 2007
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Detailed Description:

Chemotherapy and radiation therapy for cancer can compromise the ability to become pregnant. Experiments in animals and humans have tried to collect, freeze and store eggs to see if they can be saved for possible later use. While studies are promising, it is still uncertain whether such approaches will ultimately prove to be useful in practice for achieving pregnancy in humans. The main purpose of this study is to see whether it is possible to remove and store ovarian tissues by freezing. It is hoped that, in the future, frozen, stored ovarian tissue can be used to achieve pregnancy. Before receiving chemotherapy or radiation therapy, subjects will have a piece of the ovaries, or one of two ovaries, removed by surgery. The tissues will be frozen by a special method in an effort to prevent the eggs from being damaged. The majority (80%) of the tissue will be stored for potential use in case the patient is unable to achieve pregnancy in the future, and part of the tissue (20%) will be used for studying how the eggs can be grown in the laboratory.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057745

Locations
United States, Pennsylvania
Penn Fertility Care, 3701 Market Street, Suite 800
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Clarisa Gracia, MD, MSCE University of Pennsylvania
  More Information

Publications:
Responsible Party: Clarisa 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: March 17, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
woman
chemotherapy
radiation
fertility preservation
cryobank

ClinicalTrials.gov processed this record on May 27, 2015