Transplantation of Frozen Thawed Ovarian Tissue High Reproductive Performance

January 19, 2016 updated by: Prof. Dror Meirow, Sheba Medical Center

Transplantation of Frozen Thawed Ovarian Tissue Demonstrates High Reproductive Performance and the Need to Revise Restrictive Criteria

Design: prospective cohort study. Setting: Tertiary university-affiliated ART and oncology centers. Patients: 20 cancer survivors who underwent ovarian transplantation of frozen-thawed ovarian tissue, with the aim to conceive.

Interventions: Ovarian tissue cryopreservation (OTCP) and transplantation, endocrine monitoring, IVF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Main Outcomes expected:

Endocrine profile IVF results, pregnancy rates following transplantation of ovarian tissue live-births rates following transplantation of ovarian tissue cancer disease recurrence

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria: infertile patients who stored ovarian tissue to preserve fertility prior to potentially sterilizing cancer treatments

-

Exclusion Criteria:

  • active disease, fertile patients post cancer treatment

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: infertile cancer survivors
infertile cancer survivors who seek to conceive and had frozen ovarian tissue when diagnosed years before
Procedure: transplantation of ovarian tissue
operation(mini laparotomy) for transplantation of frozen- thawed ovarian tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
menstrual bleeding (yes/no)
Time Frame: up to one year
recurrence of menstrual bleeding- yes or no
up to one year
number of oocytes per IVF cycle
Time Frame: through study completion (up to 11 years following transplantation)
number of aspirated oovytes per one IVF cycle performed
through study completion (up to 11 years following transplantation)
pregnancies
Time Frame: through study completion (up to 11 years following transplantation)
spontaneous or post IVF pregnancy rates (%)
through study completion (up to 11 years following transplantation)
live births
Time Frame: through study completion (up to 11 years following transplantation)
live birth rates (%)
through study completion (up to 11 years following transplantation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease reccurence
Time Frame: through study completion (7 months to 141 months following transplantation)
incidence of cancer disease recurrence
through study completion (7 months to 141 months following transplantation)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
FSH levels (miU/ml)
Time Frame: up to one year
as part of the endocrine profile
up to one year
E2 (pmol/ml),
Time Frame: up to one year
as part of the endocrine profile
up to one year
number of embryos per IVF cycle
Time Frame: through study completion (up to 11 years following transplantation)
through study completion (up to 11 years following transplantation)
IVF cycles pregnancy rates (%)
Time Frame: through study completion (up to 11 years following transplantation)
number of pregnancies obtained via IVF devided by number of IVF cycles
through study completion (up to 11 years following transplantation)

Collaborators and Investigators

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

Sponsor

Sheba Medical Center

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

January 1, 2004

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 19, 2016

First Posted (Estimate)

January 20, 2016

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SHEBA-03-3026-DM-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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