Improving Human Ovarian Transplantation

Fertility Preservation Clinical Trial

Official title:

Phase 1 Study to Improve Results of Human Ovarian Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00827476
• Other study ID #: 0530-08-HMO- CTIL
• Status: Active, not recruiting
• Phase: Phase 0
• First received: January 21, 2009
• Last updated: January 21, 2009
• Start date: January 2009
• Est. completion date: January 2015

Study information

• Verified date: January 2009
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

we will perform xenotransplantation and in vitro culture of ovarian tissue from patients undergoing ovarian cortex cryopreservation.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2015
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 5 Years to 40 Years

Eligibility

Inclusion Criteria:

• tissue previously obtained

Exclusion Criteria:

• no tissue available or no consent

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fertility Preservation

Intervention

Procedure:
• ovarian transplantation
ovarian xenotransplantation or in vitro culture

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Israel Science Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improving folliculogenesis and oocuyte maturation after ovarian transplantation		2 years	No