Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
25 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-05-31
Study Completion Date
2025-03-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Malignancy
Fertility
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Cryopreservation
The ovarian tissue is frozen and banked at the in vitro fertilization lab at the Center for Health and Healing at OHSU.
Group Type
EXPERIMENTAL
Tissue sample storage
Intervention Type
OTHER
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.
Interventions
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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.
Intervention Type
OTHER
Eligibility Criteria
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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.
* 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.
* Women whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
Minimum Eligible Age
18 Years
Maximum Eligible Age
41 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Oregon Health and Science University
OTHER
Sponsor Role
lead
Responsible Party
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David M Lee
MD, Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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David M Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Sciences University
Locations
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Oregon Health and Sciences Universtiy
Portland, Oregon, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Womens Health Research Unit Recruitment Line
Role: CONTACT
503-494-3666
References
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Reference Type
BACKGROUND
Oktay K, Newton H, Gosden RG. Transplantation of cryopreserved human ovarian tissue results in follicle growth initiation in SCID mice. Fertil Steril. 2000 Mar;73(3):599-603. doi: 10.1016/s0015-0282(99)00548-8.
Reference Type
BACKGROUND
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
Reference Type
BACKGROUND
Kim SS, Kang HG, Kim NH, Lee HC, Lee HH. Assessment of the integrity of human oocytes retrieved from cryopreserved ovarian tissue after xenotransplantation. Hum Reprod. 2005 Sep;20(9):2502-8. doi: 10.1093/humrep/dei099. Epub 2005 Jun 9.
Reference Type
BACKGROUND
Related Links
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http://www.ohsuwomenshealth.com/research/index.html
Related Info
Other Identifiers
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U54RR024347
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB00005031
Identifier Type: OTHER
Identifier Source: secondary_id
U54RR024347
Identifier Type: -
Identifier Source: org_study_id
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