Ovarian Tissue Freezing For Fertility Preservation

Last updated: June 30, 2023
Sponsor: Oregon Health and Science University
Overall Status: Active - Recruiting

Phase

4

Condition

Neoplasms

Cancer

Carcinoma

Treatment

Tissue sample storage

Clinical Study ID

NCT00902720
U54RR024347
IRB Number: IRB00005031
NIH Grant: U54RR024347
IRB00005031
U54RR024347
  • Ages 18-41
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Woman between the age of 18-41 years who will undergo surgery, chemotherapy, drugtreatment and/or radiation for the treatment or prevention of a medical condition ormalignancy expected to result in permanent and complete loss of subsequent ovarianfunction or have a medical condition or malignancy that requires removal of all orpart of one or both ovaries.
  • Patients may have newly diagnosed or recurrent disease. Those who were not enrolled atthe time of initial diagnosis are eligible if they have not received therapy that isviewed 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 priorto undergoing cancer treatments (surgery, chemotherapy or radiation) will be eligiblefor enrollment with informed consent.
  • Signed an approved informed consent and authorization permitting the release ofpersonal health information. The patient and/or the patient's legally authorizedguardian must acknowledge in writing that consent for specimen collection has beenobtained, in accordance with institutional policies approved by the U.S. Department ofHealth and Human Services.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Tissue sample storage
Phase: 4
Study Start date:
May 01, 2009
Estimated Completion Date:
March 31, 2025

Study Description

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.

Connect with a study center

  • Oregon Health and Sciences Universtiy

    Portland, Oregon 97239
    United States

    Active - Recruiting

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