Oral Dydrogesterone Versus Vaginal Progesterone Gel in the Luteal Phase Support: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 853
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and the vaginal progesterone, used for luteal phase support.
(Initial start date was January 2009 but not for patients' recruitment only for paper work, documents, team organization, statistical pre-work actions and to gain the official approval of Institutional Review Board. The recruitment started in October 2010 and continued until October 2013.)
详细描述
The use of gonadotropin-releasing hormone (GnRH) agonists in the ovarian stimulation, which prevents a premature surge of luteal hormone (LH), ultimately leads to suppression of the pituitary gland and high levels of estrogen observed during induced cycles result in inhibiting effect on the implantation of human embryos.
The luteal support in in-vitro-fertilization (IVF) cycles can be prolonged using human chorion gonadotropin(hCG) and/or progesterone.
Since it has been noted that the use of hCG was related with higher risks of the onset of ovarian hyperstimulation syndrome (OHSS), progesterone is nowadays a product of choice in luteal support.
Currently vaginal progesterone is widely used, since the classic oral progesterone results in low bioavailability and lower pregnancy rate and the intramuscular progesterone (IM-P) daily injections are painful and may cause abscesses, inflammatory reactions and local soreness.
However, standard protocol for luteal phase support has not been established (i.e. optimal dosage, route or duration).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •routine ovulation induction protocol with GnRH agonist
- •less than three prior IVF cycles
- •at least three aspirated oocytes
- •BMI <35 kg/m2
- •age <45 years
排除标准
- •history of dysfunctional uterine bleeding
- •acute urogenital disease
- •recurrent miscarriage
- •previous allergic reactions to a progesterone products
研究组 & 干预措施
Oral dydrogesterone
Study group receiving 2x10mg of oral dydrogesterone until a pregnancy test or in the case of pregnancy until 10 week.
干预措施: Oral dydrogesterone (Drug)
Crinone 8% vaginal gel
Control group is receiving vaginal gel, 1x90mg, until a pregnancy test or in the case of pregnancy until 10 week.
干预措施: Crinone 8% gel (Drug)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 12 weeks
Ongoing pregnancy rate is defined by the presence of gestational sac(s) with viable fetal heart beats at 12 weeks' gestation by transvaginal ultrasound.
次要结局
- Number of participants with adverse events(10 weeks)
- Satisfaction(10 weeks)