Clinical Trials in Italy / NCT06261658
Recruiting
Not applicable
Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma
NCT06261658 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
CryopreservationOvary InjuryInfertility, FemaleMenopause Ovarian Failure
Investigational drug(s) / intervention(s)
Cryopreserved Ovarian Tissue Reimplantation
Cryopreserved Ovarian Tissue Reimplantation: Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma
Study 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.
Eligibility
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.
Primary outcome measure(s)
- 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Diego Raimondo | Bologna | BO | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06261658 on ClinicalTrials.gov ↗ ← All trials in Italy