Ovarian Freezing Before Cancer Treatment

NCT ID: NCT01057745

Last Updated: 2021-04-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-06-12
• Study Completion Date: 2020-03-31

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.

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.

Conditions

Effects of Chemotherapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clarisa Gracia, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Penn Fertility Care, 3701 Market Street, Suite 800

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22466745 (View on PubMed)

Other Identifiers

806062

Identifier Type: -

Identifier Source: org_study_id