Transplantation of Frozen Thawed Ovarian Tissue High Reproductive Performance

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Reproductive Performance Following Ovarian Transplantation

Intervention / Treatment
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* Procedure: transplantation of ovarian tissue


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fertility preservation, ovarian tissue transplantation, ovarian endocrine function, assisted reproductive technology, pregnancy and live birth