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Completed

NCT Number: NCT02659592

Transplantation of Frozen Thawed Ovarian Tissue High Reproductive Performance

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.

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Key information

Conditions

Reproductive Performance Following Ovarian Transplantation

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transplantation of ovarian tissue

Procedure

operation(mini laparotomy) for transplantation of frozen- thawed ovarian tissue

Primary outcomes

  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 outcomes

  1. disease reccurence

    Time frame: through study completion (7 months to 141 months following transplantation)

    incidence of cancer disease recurrence

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2015
Study completion
2015
First posted
Jan 20, 2016
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.