A Prospective, Randomized Controlled Study to Investigate the CLBRs of GnRH Antagonist Protocol Compared With the Standard GnRH Agonist Long Protocol for Controlled Ovarian Stimulation in Supposed Normal Ovarian Responders
试验速览
- 阶段
- 不适用
- 入组人数
- 888
- 试验地点
- 4
- 主要终点
- the cumulative live birth rates
研究概览
简要总结
This is a Phase IV, prospective, randomized controlled study to investigate the cumulative live birth rates (CLBRs) of gonadotrophin-releasing hormone (GnRH) antagonist protocol (GnRH-ant group) compared with the standard GnRH agonist long protocol (GnRH-a group) for controlled ovarian stimulation in supposed normal ovarian responders.
详细描述
This is a Phase IV, prospective, randomized controlled study to investigate the cumulative live birth rates (CLBRs) of gonadotrophin-releasing hormone (GnRH) antagonist protocol (GnRH-ant group) compared with the standard GnRH agonist long protocol (GnRH-a group) for controlled ovarian stimulation in supposed normal ovarian responders.
In this study, patients who are planning to undergo IVF/ICSI cycle aged ≤38 years old with normal ovarian reserve will be considered for enrollment. Approximately 888 patients will be enrolled at approximately 5 centers in China over a period of 10 months.
About 12-20 visits will be performed in this study for each patient. The CLBR with first live birth resulting from one initiated COS cycle will be compared between GnRH-a group and GnRH-ant group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women planning to undergo IVF/ICSI cycle using conventional GnRH agonist long protocol or GnRH antagonist protocol
- •Age ≤ 38 years old
- •Basal AFC 8~20
- •Basal FSH≤10 IU/L
- •Basal E 2 <200pmol/L
- •Normal uterus and at least one side of the normal ovary
- •Informed consent form signed
- •Willing to follow the study protocol, and able to complete this study
排除标准
- •Previous IVF/ICSI cycles >2
- •Severe hydro-salpinx (Ultrasound shows hydro salpinx﹥2cm)
- •Severe endometriosis (Grade III - IV)
- •Polycystic ovarian syndrome (PCOS)
- •History of recurrent miscarriages (>2 times of miscarriages)
- •Plan to undergo ovarian stimulation for preimplantation genetic diagnosis or preimplantation genetic screening, oocyte donation, and social or medical freezing of oocytes
- •Any major systemic disease that as per Investigator's discretion precludes subject for participation in the study
- •With pregnancy contraindications
- •Alcoholism, drug abuse, drug addiction or patients with uncured sexually transmitted disease
- •According to the judgment of the Investigator, any medical condition or any concomitant surgery/medications that would interfere with evaluation of study medications
- •Simultaneous participation in another clinical study
- •Plan to use urinary gonadotrophin during COS treatment
结局指标
主要结局
the cumulative live birth rates
时间窗: two years
To investigate the cumulative live birth rates in infertile women ≤ 38 years old with normal ovarian from one initiated COS cycle. reserve using GnRH antagonist or agonist protocol for COS in ART treatment Numerator is the No. of women got their first live birth, the Denominator is the No. of women who attempt the ovarian stimulation. There will be two ways to calculate the CLBR: * The conservative estimate of the cumulative live birth rate, which is based on the assumption that none of the women who do not return for a subsequent embryo transfer would have had a live birth. * The optimal estimate of the cumulative live birth rate, which is based on the assumption that women who do not return for a subsequent embryo transfer would have had the same live birth rates as those who do return.
次要结局
- Good-quality embryo rate (The Istanbul Consensus29)(24 hours after Oocytes pick up)
- Rate of OHSS(two weeks after Oocytes pick up)
- Number of oocytes retrieved(24 hours after Oocytes pick up)
- hCG positive rate(after 11 to 17 days of ET)
- Implantation rate(4 to 6 weeks after ET)
- Ongoing pregnancy rate(after 12 weeks of ET)
- Cumulative clinical pregnancy rate(two years)
- Clinical pregnancy rate(after 4 to 6 weeks of ET)
- Live birth rate(two years)
- Miscarriage rate(after 12 weeks of ET)
- Cycle cancelled rate and reason(On ART cycle)
- Time to pregnancy(4 to 6 weeks after ET)
- Ectopic pregnancy rate(after 4 to 6 weeks of ET)
- severity of OHSS(two weeks after Oocytes pick up)
- Time to live birth(nine months after pregnancy)
- the Safety(Two years after signature of informed consent)
研究者
Jie Qiao
Professor
Peking University Third Hospital