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Vitrification for Ovarian Tissue Harvesting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649087
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Maximilian Franz, M.D., Medical University of Vienna

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovary; Anomaly Other: Vitrification Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Vitrification of ovarian tissue
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Testing of Vitrification Protocols for Ovarian Tissue Harvesting in Female to Male Transsexuals
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : December 1, 2018

Intervention Details:
  • Other: Vitrification
    Vitrification of ovarian tissue


Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female-to-male transsexuals
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03649087


Contacts
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Contact: Julian Marschalek, MD 0043140400 ext 28970 julian.marschalek@meduniwien.ac.at
Contact: Detlef Pietrowski, Dr. 0043140400 ext 28970 detlef.pietrowski@meduniwien.ac.at

Locations
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Austria
University Clinic of Obstetrics and Gynaecology of the Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Julian Marschalek, MD    0043140400 ext 28970    julian.marschalek@meduniwien.ac.at   
Contact: Detlef Pietrowski, Dr.    0043140400 ext 28970    detlef.pietrowski@meduniwien.ac.at   
Principal Investigator: Christian Egarter, Prof. MD         
Sponsors and Collaborators
Maximilian Franz, M.D.

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Responsible Party: Maximilian Franz, M.D., MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03649087    
Other Study ID Numbers: 2204
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Congenital Abnormalities