Actively Recruiting
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2024-02-15
45
Participants Needed
1
Research Sites
469 weeks
Total Duration
Researchers are evaluating the effects of injecting a patient's own platelet-enriched plasma into the ovary during the transplantation of cryopreserved ovarian tissue. This study focuses on improving outcomes for women with conditions such as premature ovarian failure, irregular menstrual cycles, ovary injury, infertility, or menopause-related ovarian failure. The research is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna and aims to assess safety and effectiveness over time. The treatment being studied involves reimplanting cryopreserved ovarian tissue combined with platelet-enriched autologous plasma. This procedure is designed to potentially enhance the quality and function of the transplanted tissue. Participants will receive this specialized transplantation intervention as part of the study. During the study, participants will be monitored for safety during the first year after transplantation and for effectiveness over a period of up to nine years. Researchers will evaluate various health outcomes related to the transplantation process, including any complications or benefits. The total duration of participation may extend up to nine years to fully assess long-term effects.
CONDITIONS
Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo cryopreserved ovarian tissue reimplantation using platelet-enriched autologous plasma.
1 implantation visit followed by periodic monitoring visits during the first year
Duration - Up to 9 years
Participants are monitored for long-term effectiveness and safety of the reimplantation procedure.
Annual visits for up to 9 years
Total: 1 location
1
Diego Raimondo
Bologna, BO, Italy, 40138
Actively Recruiting
D
Diego Raimondo, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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