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Completed

NCT Number: NCT01993732

Ovarian Tissue Cryopreservation in Females Undergoing Procedures That Will Potentially Lead To 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.

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Key information

Age range

3 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retrieval and Cryopreservation

Procedure

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 outcomes

  1. Return of hormones produced by the ovarian tissue

    Time frame: 3 months after re-implantation

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 25, 2013
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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