Recruiting

Ovarian Tissue Freezing

Sponsor:

Oregon Health and Science University

Code:

NCT00902720

Conditions

Malignancy

Fertility

Eligibility Criteria

Sex: Female

Age: 18 - 41

Healthy Volunteers: Accepted

Interventions

Tissue sample storage

Study Details

Brief 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.

Conditions

Malignancy

Fertility

Study ID

NCT00902720

Start date

May, 2009

Status verified date

Jun, 2023

Completion date

Mar, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 41

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Cryopreservation

The ovarian tissue is frozen and banked at the in vitro fertilization lab at the Center for Health and Healing at OHSU.

Interventions

Tissue sample storage

The tissue sample is frozen and held at -140 degrees at the in vitro fertilization lab at the Center for Health and Healing at OHSU.

Primary outcome measure

  • This study will provide a pool of research ovarian tissue to use to develop and test methods to expand the range of fertility preservation options available to female cancer patients. [ Time Frame: May 2009 - January 2010 ]

Central Contacts and Locations

Central contacts

David M Lee, MD

503-418-3700leedavi@ohsu.edu

Womens Health Research Unit Recruitment Line

503-494-3666

Locations

Oregon Health and Sciences Universtiy

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

David M Lee, MD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Jul 5, 2023

Last verified

Jun, 2023

Keywords

  • Ovarian
  • Tissue
  • Cryopreservation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2023-07-05.