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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| infertile cancer survivors | Experimental | infertile cancer survivors who seek to conceive and had frozen ovarian tissue when diagnosed years before |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transplantation of ovarian tissue | Procedure | operation(mini laparotomy) for transplantation of frozen- thawed ovarian tissue |
|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| disease reccurence | incidence of cancer disease recurrence | through study completion (7 months to 141 months following transplantation) |
| Measure | Description | Time Frame |
|---|---|---|
| FSH levels (miU/ml) | as part of the endocrine profile | up to one year |
| E2 (pmol/ml), | as part of the endocrine profile | up to one year |
Inclusion Criteria: infertile patients who stored ovarian tissue to preserve fertility prior to potentially sterilizing cancer treatments
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Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27181924 | Derived | Meirow D, Ra'anani H, Shapira M, Brenghausen M, Derech Chaim S, Aviel-Ronen S, Amariglio N, Schiff E, Orvieto R, Dor J. Transplantations of frozen-thawed ovarian tissue demonstrate high reproductive performance and the need to revise restrictive criteria. Fertil Steril. 2016 Aug;106(2):467-74. doi: 10.1016/j.fertnstert.2016.04.031. Epub 2016 May 12. |
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| number of embryos per IVF cycle | through study completion (up to 11 years following transplantation) |
| IVF cycles pregnancy rates (%) | number of pregnancies obtained via IVF devided by number of IVF cycles | through study completion (up to 11 years following transplantation) |