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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cancer, Effects of Chemotherapy, Unspecified Complication of Bone Marrow Transplant, Auto Immune Disease

Intervention / Treatment
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* Procedure: Retrieval and Cryopreservation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retrieval and Cryopreservation<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return of hormones produced by the ovarian tissue |  | 3 months after re-implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of egg(s) appropriate for use in in vitro fertilization |  | Participants will be followed through their reproductive years (until the patient reaches 45 years of age) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Cryopreservation, Ovarian Function, In Vitro