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临床试验/NCT03354494
NCT03354494已完成不适用

Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa for Ovarian Stimulation in Donors

Institut Universitari Dexeus0 个研究点目标入组 40 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

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

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

发起方
Institut Universitari Dexeus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Francisca Martínez

MD PhD

Institut Universitari Dexeus

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