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Ovarian Tissue Cryopreservation in Females Undergoing Procedures That Will Potentially Lead To Loss of Ovarian Function

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ClinicalTrials.gov Identifier: NCT01993732
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Estil Strawn, Medical College of Wisconsin

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.

Condition or disease Intervention/treatment Phase
Cancer Effects of Chemotherapy Unspecified Complication of Bone Marrow Transplant Auto Immune Disease Procedure: Retrieval and Cryopreservation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : August 6, 2013
Actual Primary Completion Date : June 28, 2018
Actual Study Completion Date : June 28, 2018

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.
Procedure: 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.




Primary Outcome Measures :
  1. Return of hormones produced by the ovarian tissue [ Time Frame: 3 months after re-implantation ]

Secondary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993732


Locations
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United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Estil Strawn, MD Medical College of Wisconsin
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Responsible Party: Estil Strawn, Professor, Director of Division of Reproductive Endocrinology and Infertility, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01993732    
Other Study ID Numbers: 126204
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Estil Strawn, Medical College of Wisconsin:
Cancer
Cryopreservation
Ovarian Function
In Vitro
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases