Ovarian Tissue Freezing For Fertility Preservation

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
David M Lee, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00902720
First received: May 14, 2009
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Malignancy
Fertility
Other: Tissue sample storage
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen: A Study By The National Physicians Cooperative of the Oncofertility Consortium At Northwestern University

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Optimize techniques for freezing and thawing of ovarian tissue for use in transplant or in vitro follicle maturation (IFM). [ Time Frame: May 2009 - January 2010 ] [ Designated as safety issue: No ]
  • Investigate factors affecting successful maturation of immature follicles obtained from ovarian tissue including the use of 3-dimensional biogel scaffolds, growth factors, hormones and other culture conditions. [ Time Frame: May 2009 - January 2010 ] [ Designated as safety issue: No ]
  • Determine the efficacy of ovarian cryopreservation techniques. [ Time Frame: May 2009 - January 2010 ] [ Designated as safety issue: No ]
  • Provide long term follow up on patients who have ovarian tissue frozen for their own use. [ Time Frame: May 2009 - January 2010 ] [ Designated as safety issue: No ]
  • A substantial portion of the patient's tissue will be cryopreserved and reserved for her own use. [ Time Frame: May 2009 - January 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: May 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cryopreservation
The ovarian tissue is frozen and banked at the in vitro fertilization lab at the Center for Health and Healing at OHSU.
Other: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  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: NCT00902720

Contacts
Contact: David M Lee, MD 503-418-3700 leedavi@ohsu.edu
Contact: Womens Health Research Unit Recruitment Line 503-494-3666

Locations
United States, Oregon
Oregon Health and Sciences Universtiy Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: David M Lee, MD         
Sub-Investigator: David E Battaglia, MD         
Sub-Investigator: Kenneth A Burry         
Sub-Investigator: Marsha J Gorrill, MD         
Sub-Investigator: Phillip E Patton, MD         
Sub-Investigator: Paula Amato, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: David M Lee, MD Oregon Health and Sciences University
  More Information

Publications:
Meirow D. Epidemiology and infertility in cancer patients. In: Gosden R, Tulandi T, editors. Preservation of fertility. London: Taylor and Francis, 2004:21-38.
Parrot D. The fertility of mice with orthotopic ovarian grafts derived from frozen tissue. J Reprod Fertil 1960;1:230-241
Lee DM, Yeoman R, Battaglia DE, et al. Birth of a monkey after heterotopic transplantation of fresh ovarian tissue and assisted reproduction. Nature 2004;428:137-138
Schnorr JA OS, Toner JP, Hsiu JG, Willams RF, Hodgen GD. Fresh and cryopreserved extrapelvic ovarian transplantation in non-human primates: folliculogenesis, ovulation, corpus luteum function, endometrial development, and menstrual patterns. Abstract presented at: the American Society of Reproductive Medicine 2000 Annual Meeting; October 21-26, 2000; San Diego, California
Lee DM, Yeoman RR, Yu T, et al. Sphingosine-1-phosphate inhibits apoptosis in rhesus monkey ovarian tissue in vitro and may improve reproductive function in xenografts. 2005 Joint American Society for Reproductive Medicine/Canadian Fertility & Andrology Society Meeting, Oct. 15-19, Montreal, Quebec, CANADA. Fertil Steril 2005;84(Suppl 1):S2
Kim SS, Soules M, Gosden RG, et al. The evidence of follicle maturation and subsequent ovulation in human ovarian tissue xenografted into severe combined immunodeficient (SCID)mice. Fertil Steril 2000;74:S34
Lee K, Lee S, SJ Y, et al. Resumption of the human primordial follicle growth in xenografts after vitrification of the ovarian tissues. Fertil Steril 2000;74(3 Suppl 1):S214

Responsible Party: David M Lee, MD, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00902720     History of Changes
Other Study ID Numbers: U54RR024347, NIH Grant: U54RR024347, IRB Number: IRB00005031
Study First Received: May 14, 2009
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Ovarian
Tissue
Cryopreservation

ClinicalTrials.gov processed this record on September 18, 2014