Vitrification for Ovarian Tissue Harvesting

August 25, 2018 updated by: Maximilian Franz, M.D.

Testing of Vitrification Protocols for Ovarian Tissue Harvesting in Female to Male Transsexuals

Increasing interest has emerged concerning ovarian tissue cryopreservation and subsequent transplantation as a potential way of preserving fertility in cancer patients as well as for women who just wish to delay childbearing. As the majority of existing protocols use the slow freezing method, this study aims to test vitrification techniques of ovarian cortex.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

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

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • University Clinic of Obstetrics and Gynaecology of the Medical University of Vienna
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Egarter, Prof. MD

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female-to-male transsexuals
  • gender completing operation
  • signed informed consent form
  • willingness to donate ovarian tissue for research purposes
  • age >=18 years

Exclusion Criteria:

  • malignant disease
  • age under 18 years
  • refusal to donate ovarian tissue

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival of ovarian tissue
Time Frame: 2 days until 2 years after freezing
histologic and enzymatic evaluation of ovarian tissue with respect to survival and functionality of ovarian follicles
2 days until 2 years after freezing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maximilian Franz, M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2017

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 29, 2017

First Submitted That Met QC Criteria

August 25, 2018

First Posted (Actual)

August 28, 2018

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 25, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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