About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
request for cryopreserved ovarian tissue transplantation;
premature ovarian failure or irregular mentrual cycles;
negative test for HIV, HBV, HCV, Treponema pallidum;
negative PAP test;
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
Cryopreserved Ovarian Tissue Reimplantation
Procedure/SurgeryCryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma
Treatment groups
Trial outcomes
Primary outcomes
Safety of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma
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 outcomes
Effectiveness of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma
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.
Sponsors and contacts
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