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Transplantation of Frozen Thawed Ovarian Tissue High Reproductive Performance

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ClinicalTrials.gov Identifier: NCT02659592
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Dror Meirow, 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.


Condition or disease Intervention/treatment Phase
Reproductive Performance Following Ovarian Transplantation Procedure: transplantation of ovarian tissue Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transplantation of Frozen Thawed Ovarian Tissue Demonstrates High Reproductive Performance and the Need to Revise Restrictive Criteria
Study Start Date : January 2004
Actual Primary Completion Date : March 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. menstrual bleeding (yes/no) [ Time Frame: up to one year ]
    recurrence of menstrual bleeding- yes or no

  2. 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

  3. pregnancies [ Time Frame: through study completion (up to 11 years following transplantation) ]
    spontaneous or post IVF pregnancy rates (%)

  4. live births [ Time Frame: through study completion (up to 11 years following transplantation) ]
    live birth rates (%)


Secondary Outcome Measures :
  1. disease reccurence [ Time Frame: through study completion (7 months to 141 months following transplantation) ]
    incidence of cancer disease recurrence


Other Outcome Measures:
  1. FSH levels (miU/ml) [ Time Frame: up to one year ]
    as part of the endocrine profile

  2. E2 (pmol/ml), [ Time Frame: up to one year ]
    as part of the endocrine profile

  3. number of embryos per IVF cycle [ Time Frame: through study completion (up to 11 years following transplantation) ]
  4. 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



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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Exclusion Criteria:

  • active disease, fertile patients post cancer treatment
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dror Meirow, professor, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02659592    
Other Study ID Numbers: SHEBA-03-3026-DM-CTIL
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Prof. Dror Meirow, Sheba Medical Center:
fertility preservation
ovarian tissue transplantation
ovarian endocrine function
assisted reproductive technology
pregnancy and live birth