Transplantation of Frozen Thawed Ovarian Tissue High Reproductive Performance

Phase 3

Completed

• Conditions: Reproductive Performance Following Ovarian Transplantation
• Interventions: Procedure: transplantation of ovarian tissue

• Registration Number: NCT02659592
• Lead Sponsor: Sheba Medical Center

Brief Summary

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.

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 Timeline

• Study Start: 2004-01
• Primary Completion: 2015-03
• Study Completion: 2015-12
• Status Verified: 2016-01
• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-19
• Last Update Submitted: 2016-01-19
• Study First Posted: 2016-01-20
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
infertile cancer survivors	transplantation of ovarian tissue	infertile cancer survivors who seek to conceive and had frozen ovarian tissue when diagnosed years before

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
disease reccurence	through study completion (7 months to 141 months following transplantation)	incidence of cancer disease recurrence