- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01993732
Ovarian Tissue Cryopreservation in Females Undergoing Procedures That Will Potentially Lead To Loss of Ovarian Function
August 13, 2019 updated by: Estil Strawn, Medical College of Wisconsin
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Froedtert and The Medical College of Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Children's Hospital of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Retrieval and Cryopreservation
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Return of hormones produced by the ovarian tissue
Time Frame: 3 months after re-implantation
|
3 months after re-implantation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
Participants will be followed through their reproductive years (until the patient reaches 45 years of age)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Estil Strawn, MD, Medical College of Wisconsin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 6, 2013
Primary Completion (Actual)
June 28, 2018
Study Completion (Actual)
June 28, 2018
Study Registration Dates
First Submitted
September 18, 2013
First Submitted That Met QC Criteria
November 19, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Actual)
August 14, 2019
Last Update Submitted That Met QC Criteria
August 13, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 126204
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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