Ovarian Tissue Freezing For Fertility Preservation

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT00902720
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 151
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignancy; Fertility	Other: Tissue sample storage	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Actual Study Start Date: May 1, 2009
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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. [May 2009 - January 2010]

Secondary Outcome Measures

1. Optimize techniques for freezing and thawing of ovarian tissue for use in transplant or in vitro follicle maturation (IFM). [May 2009 - January 2010]

2. 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. [May 2009 - January 2010]

3. Determine the efficacy of ovarian cryopreservation techniques. [May 2009 - January 2010]

4. Provide long term follow up on patients who have ovarian tissue frozen for their own use. [May 2009 - January 2010]

5. A substantial portion of the patient's tissue will be cryopreserved and reserved for her own use. [May 2009 - January 2010]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 41 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health and Sciences Universtiy	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Oregon Health and Science University

Investigators

• Principal Investigator: David M Lee, MD, Oregon Health and Sciences University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

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• Responsible Party: David M Lee, MD, Associate Professor, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT00902720
• Other Study ID Numbers: U54RR024347; NIH Grant: U54RR024347; IRB Number: IRB00005031
• First Posted: May 15, 2009
• Last Update Posted: Jan 13, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by David M Lee, MD, Associate Professor, Oregon Health and Science University: Ovarian; Tissue; Cryopreservation
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jan 13, 2021