Improving Human Ovarian Transplantation

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Israel Science Foundation

Information provided by:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00827476

First received: January 21, 2009

Last updated: NA

Last verified: January 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	January 21, 2009
Last Updated Date	January 21, 2009
Start Date ^ICMJE	January 2009
Estimated Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 21, 2009)	improving folliculogenesis and oocuyte maturation after ovarian transplantation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Improving Human Ovarian Transplantation
Official Title ^ICMJE	Phase 1 Study to Improve Results of Human Ovarian Transplantation
Brief Summary	we will perform xenotransplantation and in vitro culture of ovarian tissue from patients undergoing ovarian cortex cryopreservation.
Detailed Description	Ovarian tissue is removed by laparoscopy and only in patients facing premature ovarian failure due to chemotherapy.Tissue for research will consist either of a small portion (<10%) of the cortex for preservation for young women. another source of ovarian tissue for research will be obtained following consent from family of patients who have died of the disease and have previously frozen ovarian tissue.
Study Type ^ICMJE	Interventional
Study Phase	Phase 0
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Fertility Preservation
Intervention ^ICMJE	Procedure: ovarian transplantation ovarian xenotransplantation or in vitro culture
Study Arm (s)	Experimental: ovarian transplantation tissue will be used for xenotransplantation or in vitro culture Intervention: Procedure: ovarian transplantation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	January 2015
Estimated Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: tissue previously obtained Exclusion Criteria: no tissue available or no consent
Gender	Female
Ages	5 Years to 40 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00827476
Other Study ID Numbers ^ICMJE	0530-08-HMO- CTIL
Has Data Monitoring Committee	Yes
Responsible Party	Ariel Revel, Hadassah Medical Organization
Study Sponsor ^ICMJE	Hadassah Medical Organization
Collaborators ^ICMJE	Israel Science Foundation
Investigators ^ICMJE	Not Provided
Information Provided By	Hadassah Medical Organization
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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