Cryopreservation, Infertility, Female, Menopause Ovarian Failure, Ovary Injury
Conditions
Keywords
Cryopreserved Ovarian Tissue, Ovarian tissue transplantation, Platelet-enriched Autologous Plasma, ovarian endocrine function, livebirths
Brief summary
The study is aimed to evaluate the effects of intraovarian injection of autologous Platelet-enriched Autologous Plasma on the outcomes of orthotopic transplantation of cryopreserved ovarian tissue.
Interventions
PROCEDURECryopreserved Ovarian Tissue Reimplantation
Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* request for cryopreserved ovarian tissue transplantation; * premature ovarian failure or irregular mentrual cycles; * negative test for HIV, HBV, HCV, Treponema pallidum; * negative PAP test; * oncological authorization; * absence of neoplastic contamination in the cryopreserved ovarian tissue; * Informed consent
Exclusion criteria
* neoplastic contamination in cryopreserved ovarian tissue; * history of endometriosis; * endocrinological disorders present and not treated (uncompensated thyroid dysfunction, diabetes (type 1, type 2); * body mass index (BMI) \>30 kg/m2; * circulating platelet level \< 150,000 / mml; * bacterial infection; * ongoing use of anticoagulants; * bleeding diathesis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma | first year | to evaluate the safety of intraovarian PRP injection in terms of absence of adverse reactions to laparoscopic ovarian tissue reimplantation surgery. Patients in early menopause or with irregular menstrual cycles who have cryopreserved their ovarian tissue at the Cryobank of Division of Gynaecology and Human Reproduction Physiopathology, IRCCS Azienda Ospedaliero-Universitaria di Bologna will be recruited. These patients will be joined by a historical cohort of patients who have the inclusion criteria of this study and who have already undergone reimplantation of ovarian tissue as the routine clinical care procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma | 9 years | to evaluate whether the use of autologous PRP during the ovarian tissue transplantation leads to an improvement of outcomes in terms of ovarian function recovery (endocrine and reproductive functions). Patients in early menopause or with irregular menstrual cycles who have cryopreserved their ovarian tissue at the Cryobank of Division of Gynaecology and Human Reproduction Physiopathology, IRCCS Azienda Ospedaliero-Universitaria di Bologna will be recruited. These patients will be joined by a historical cohort of patients who have the inclusion criteria of this study and who have already undergone reimplantation of ovarian tissue as the routine clinical care procedure. |
Countries
Italy
Contacts
Primary ContactDiego Raimondo, MD
Outcome results
None listed