Desogestrel and Corifollitropin Treatment for Ovarian Stimulation in Donors
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 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. It has been described the usefulness of orally administered medroxyprogesterone acetate, 10 mg to inhibit the endogenous LH surge in IVF patients during COS.
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. No description of the hormonal and ovarian response under this protocol has been published
详细描述
- oral desogestrel since the first menstruation day,
- a single injection of FSH-CTP on the 7th menstrual cycle day
- routine monitoring of ovarian response with transvaginal ultrasound every second day until pre-ovulatory bolus of GnRH
- Hormones measured on day of 7th menstrual cycle day , day of pre-ovulatory bolus of GnRH and the day after the bolus ( estradiol, FSH, Progesterone, LH)
- Quality of Life questionnaire the day after the bolus
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
- 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
- •Population: donors (18-35 ) from candidates of Donor program
- •Fulfilling inclusión medical and legal criteria (RD -Ley de transposición de la normativa europea a la legislación española 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
FSH-CTP + DESOGESTREL
Single injection of FSH-CTP and oral desogestrel since the first menstruation day, until bolus of GnRH agonist to follicular maturation
干预措施: FSH-CTP + DESOGESTREL (Drug)
结局指标
主要结局
Total dose of gonadotrophins
时间窗: At the end of the stimulation treatment period (5 or 7 days after begining of treatment)
Total Consume of gonadotrophins
次要结局
- Number of mature oocytes(Day of oocyte recovery)
- Plasma LH(Day of GnrH bolus)
研究者
Dr. Francisca Martínez
PhD
Institut Universitari Dexeus