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

Medical College of Wisconsin2 sites in 1 country15 target enrollmentAugust 6, 2013

ConditionsCancer Effects of Chemotherapy Unspecified Complication of Bone Marrow Transplant Auto Immune Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer
Sponsor: Medical College of Wisconsin
Enrollment: 15
Locations: 2
Primary Endpoint: Return of hormones produced by the ovarian tissue
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 6, 2013

End Date

June 28, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Medical College of Wisconsin

Responsible Party

Principal Investigator

Estil Strawn

Professor, Director of Division of Reproductive Endocrinology and Infertility

Medical College of Wisconsin

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.

Outcomes

Primary Outcomes

Return of hormones produced by the ovarian tissue

Time Frame: 3 months after re-implantation

Secondary Outcomes

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))