Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Safety of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Safety of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma
时间窗: 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.
次要结局
- Effectiveness of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma(9 years)
研究者
Renato Seracchioli
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna