Back to resultsOvarian Tissue Cryopreservation in Females Undergoing Procedures That Will Potentially Lead To Loss of Ovarian Function
Primary Purpose
Cancer, Effects of Chemotherapy, Unspecified Complication of Bone Marrow Transplant
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retrieval and Cryopreservation
Sponsored by
About this trial
This is an interventional prevention trial for Cancer focused on measuring Cancer, Cryopreservation, Ovarian Function, In Vitro
Eligibility Criteria
Inclusion Criteria:
- Patient must be female.
- Patient must have a disease process where the disease or its treatment adversely affects ovarian function.
- Patient must be recommended for this study by their oncologist or specialist.
- Patient (or legally authorized representative) must sign an informed consent.
Exclusion Criteria:
- Patients cannot be male.
- Patients must not be HIV positive.
- Patient cannot have a poor diagnosis such that she is not expected to survive to adulthood.
- Patient cannot have any medical condition that would contraindicate surgery.
- Patient cannot have any medical condition that would contraindicate general anesthesia.
- Patient cannot have any medical condition that would contraindicate pregnancy.
Sites / Locations
- Children's Hospital of Wisconsin
- Froedtert and The Medical College of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Retrieval and Cryopreservation
Arm Description
Females undergoing therapeutic procedures that will potentially lead to the irreversible loss of ovarian function will have their ovarian tissue retrieved and cryopreserved. Ideally, after treatment, the cryopreserved ovarian tissue can be thawed and auto-transplanted and ovarian function resumed.
Outcomes
Primary Outcome Measures
Return of hormones produced by the ovarian tissue
Secondary Outcome Measures
Development of egg(s) appropriate for use in in vitro fertilization
Full Information
NCT ID
NCT01993732
First Posted
September 18, 2013
Last Updated
August 13, 2019
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT01993732
Brief Title
Ovarian Tissue Cryopreservation in Females Undergoing Procedures That Will Potentially Lead To Loss of Ovarian Function
Official Title
Ovarian Tissue Cryopreservation As A Means Of Preserving Ovarian Function in Females Undergoing Therapeutic Procedures That Will Potentially Lead To The Irreversible Loss of Ovarian Function
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 6, 2013 (Actual)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
June 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to retrieve and cryopreserve ovarian tissue from females undergoing a treatment that may lead to irreversible loss of ovarian function.
Detailed Description
The aim of this preliminary study is to retrieve and properly cryopreserve ovarian tissue for autotransplantation in any premenopausal female whose ovarian function is threatened in a physiological, pathological or iatrogenic manner in an effort to observe the return of ovarian endocrine function and development of egg(s) appropriate for use in in vitro fertilization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Effects of Chemotherapy, Unspecified Complication of Bone Marrow Transplant, Auto Immune Disease
Keywords
Cancer, Cryopreservation, Ovarian Function, In Vitro
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retrieval and Cryopreservation
Arm Type
Experimental
Arm Description
Females undergoing therapeutic procedures that will potentially lead to the irreversible loss of ovarian function will have their ovarian tissue retrieved and cryopreserved. Ideally, after treatment, the cryopreserved ovarian tissue can be thawed and auto-transplanted and ovarian function resumed.
Intervention Type
Procedure
Intervention Name(s)
Retrieval and Cryopreservation
Intervention Description
Females undergoing therapeutic procedures that will potentially lead to the irreversible loss of ovarian function will have their ovarian tissue retrieved and cryopreserved. Ideally, after treatment, the cryopreserved ovarian tissue can be thawed and auto-transplanted and ovarian function resumed.
Primary Outcome Measure Information:
Title
Return of hormones produced by the ovarian tissue
Time Frame
3 months after re-implantation
Secondary Outcome Measure Information:
Title
Development of egg(s) appropriate for use in in vitro fertilization
Time Frame
Participants will be followed through their reproductive years (until the patient reaches 45 years of age)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must be female.
Patient must have a disease process where the disease or its treatment adversely affects ovarian function.
Patient must be recommended for this study by their oncologist or specialist.
Patient (or legally authorized representative) must sign an informed consent.
Exclusion Criteria:
Patients cannot be male.
Patients must not be HIV positive.
Patient cannot have a poor diagnosis such that she is not expected to survive to adulthood.
Patient cannot have any medical condition that would contraindicate surgery.
Patient cannot have any medical condition that would contraindicate general anesthesia.
Patient cannot have any medical condition that would contraindicate pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Estil Strawn, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Froedtert and The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ovarian Tissue Cryopreservation in Females Undergoing Procedures That Will Potentially Lead To Loss of Ovarian Function
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