Ovarian Tissue Freezing For Fertility Preservation
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.
|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|
- 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 ]
- 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 ]
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902720
|Contact: David M Lee, MDfirstname.lastname@example.org|
|Contact: Womens Health Research Unit Recruitment Line||503-494-3666|
|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|
|Principal Investigator:||David M Lee, MD||Oregon Health and Sciences University|