Reproductive Performance Following Ovarian Transplantation
Conditions
Keywords
fertility preservation, ovarian tissue transplantation, ovarian endocrine function, assisted reproductive technology, pregnancy and live birth
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
Interventions
PROCEDUREtransplantation of ovarian tissue
operation(mini laparotomy) for transplantation of frozen- thawed ovarian tissue
Sponsors
Sheba Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| menstrual bleeding (yes/no) | up to one year | recurrence of menstrual bleeding- yes or no |
| live births | through study completion (up to 11 years following transplantation) | live birth rates (%) |
| pregnancies | through study completion (up to 11 years following transplantation) | spontaneous or post IVF pregnancy rates (%) |
| number of oocytes per IVF cycle | through study completion (up to 11 years following transplantation) | number of aspirated oovytes per one IVF cycle performed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease reccurence | through study completion (7 months to 141 months following transplantation) | incidence of cancer disease recurrence |
Other
| Measure | Time frame | Description |
|---|---|---|
| FSH levels (miU/ml) | up to one year | as part of the endocrine profile |
| IVF cycles pregnancy rates (%) | through study completion (up to 11 years following transplantation) | number of pregnancies obtained via IVF devided by number of IVF cycles |
| number of embryos per IVF cycle | through study completion (up to 11 years following transplantation) | — |
| E2 (pmol/ml), | up to one year | as part of the endocrine profile |
Outcome results
None listed