Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa for Ovarian Stimulation in Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Total dose of gonadotrophins
研究概览
简要总结
Currently, controlled ovarian stimulation (COS) in oocyte donors is performed by daily injections of gonadotropins( recombinant FSH) plus a GnRH Antagonist usually form 5th-6th stimulation day until ovulation induction with a bolus of another injection of a gonadotropin-releasing hormone (GnRH) Agonist. Injections of the GnRH Antagonist avoid untimely luteinizing hormone (LH) surge and spontaneous ovulation prior to follicular aspiration. There is a preparation of long-acting recombinant follicle stimulating hormone (rFSH= (corifollitropin alfa (FSH-CTP), Elonva®, MSD), that allows that a single subcutaneous injection substitutes the first 7 days of daily gonadotropin injections. On the other hand, a contraceptive oral progesterone only( Desogestrel, DSG) is available for contraception, avoiding the LH surge.
In donors, by administering a single injection of FSH-CTP and oral desogestrel since the first menstruation day, the total number of injections administered is reduced and less discomfort is experienced without adverse impact on ovarian response.
Other authors have reported good results using similar synthetic progestins (Medroxyprogesterone, dihydrogesterone, and natural progesterone).
No description of the hormonal and ovarian response under this protocol has been published. Direct comparison between this novel protocol and the classical GnRH- antagonist plus daily gonadotropins has not been reported.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Fulfilling inclusión medical and legal criteria (RD - Spanish law adapting european rule-9/2014)
- •Who had had undergone previously convencional COS (controlled ovarian stimulation) with FSH-CTP and daily antagonist injections
- •Given signed consent form.
排除标准
- •Previous low response to COS
- •Previous ovarian hyperstimulation syndrome.
- •Ovarian cysts.
研究组 & 干预措施
DSG-CTP
干预措施: Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa (Drug)
结局指标
主要结局
Total dose of gonadotrophins
时间窗: At the end of stimulation treatment period (from day of corifollitropin administration until the day of triggering) ) an average 10 days after beginning treatment
Sum of gonadotrophins dose
Oocyte retrieved
时间窗: Oocyte retrieval day an average 10 days after beginning treatment
Number of oocyte retrieved
次要结局
未报告次要终点
研究者
Dr. Francisca Martínez
MD PhD
Institut Universitari Dexeus
