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Clinical Trials (PDQ®)

Ovarian Tissue Freezing For Fertility Preservation

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IVTissue collection/RepositoryActive18 to 41OtherU54RR024347
NIH Grant: U54RR024347, IRB Number: IRB00005031, NCT00902720

Trial Description

Summary

The purpose of this study is to offer an alternative method to women who wish to preserve the possibility of fertility, as well as to learn more about the ability of human eggs to survive and function after long term storage in frozen ovaries (ovarian tissue cryopreservation). The study will seek to preserve ovarian tissue and reproductive potential for patients whose medical or surgical treatment may harm ovaries or remove ovarian tissue.

Further Study Information

Women who have not yet undergone this procedure, and who present to the Fertility Consultants desiring fertility preservation, will be offered participation in the study.

Subjects will undergo an initial visit which will include a blood draw, ultrasound, and any additional tests or exams that are medically indicated for the subject's diagnosis in preparation for surgery. Subjects will then undergo an oophorectomy surgery (removal of one or both ovaries). Following removal, subject's ovarian tissue will be cryopreserved (frozen) and stored for possible future use. We also plan to collect subjects medical history information to enter into a research database. Subjects will be followed until they decide to use their tissue for fertility purposes.

We will also retrospectively enroll women who have already undergone this procedure by contacting them by mail and offering participation in our ovarian tissue cryopreservation database.

Eligibility Criteria

Inclusion Criteria:

  • Woman between the age of 18-41 years who will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy expected to result in permanent and complete loss of subsequent ovarian function or have a medical condition or malignancy that requires removal of all or part of one or both ovaries.
  • Patients may have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis are eligible if they have not received therapy that is viewed as likely to result in complete and permanent loss of ovarian function.
  • For patients undergoing elective removal of an ovary for fertility preservation only, have two ovaries.
  • Patients who already have stored cryopreserved ovarian tissue in a frozen state prior to undergoing cancer treatments (surgery, chemotherapy or radiation) will be eligible for enrollment with informed consent.
  • Signed an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.

Exclusion Criteria:

  • Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
  • Women whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.

Trial Contact Information

Trial Lead Organizations/Sponsors

Knight Cancer Institute at Oregon Health and Science University

David M Lee, MDPrincipal Investigator

David M Lee, MDPh: 503-418-3700
  Email: leedavi@ohsu.edu

Trial Sites

U.S.A.
Oregon
  Portland
 Knight Cancer Institute at Oregon Health and Science University
 David M Lee, MDPrincipal Investigator
 David E Battaglia, MDSub-Investigator
 Kenneth A BurrySub-Investigator
 Marsha J Gorrill, MDSub-Investigator
 Phillip E Patton, MDSub-Investigator
 Paula Amato, MDSub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00902720
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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