Transplantation of Ovarian Cortex to Restore Fertility | NCT01442584

Studies
Transplantation of Ovarian Cortex to Restore Fertility

NCT01442584

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Sep 28, 2011Estimated

Enrollment

5Estimated

Phase

Not Applicable

Conditions

Pregnancy

Interventions

ovarian transplantation

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Dec 2015Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Jul 13, 2011

First Submission Date that Met QC Criteria

Sep 27, 2011

First Posted Date

Sep 28, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2011

Last Update Posted Date

Sep 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Ovarian transplantation has been shown to restore fertility.

Detailed Description

The investigators transplant ovarian cortex previously collected from the patient prior to cancer treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fertility restoration by transplantation	Experimental	fertility restoration by transplantation of ovarian cortex slivers that were cryopreserved prior to chemotherapy	Procedure: ovarian transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ovarian transplantation	Procedure	ovarian transplantation	fertility restoration by transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pregnancy	we will start IVF within 3 months	3-6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who froze ovarian tissue

Exclusion Criteria:

malignant cells in ovary

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

54 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ariel revel, md	Contact	97226777111	74399	arielr2@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Ariel Revel, MD	Hadassah	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah	Recruiting	Jerusalem			Israel