A Randomized Controlled Study of Different Trigger Modes of Antagonist Regimen in Patients With Low Ovarian Reserve
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate in each transplantation cycle
研究概览
简要总结
Assisted reproductive technology (ART), especially controlled ovarian stimulation (COS), significantly increased clinical pregnancy rates among infertile patients. However, about 9% to 24% of patients had poor ovarian response to gonadotropins (GNS) stimulation, which was called poor ovarian response (POR). In recent years, the diagnosis and treatment of patients with low fertility is the challenge for reproductive medicine. To better demonstrate the effectiveness of various interventions and distinguish the different subgroups of patients, 2016 POSEIDON (Patient-Oriented Strategies Encompassing Individualized Oocyte Number) standard changed low reaction into low prognosis of patient-oriented individual strategies to obtain eggs. For patients in group 3 and group 4 classified by POSEIDON, ovarian reserve function decline, follicular development desynchrony and low numbers of oocytes obtained lead to poor prognosis. In 2020, the prognosis based on Delphi method of assisted reproductive technology to treat low crowd diagnosis expert opinion in China recommended to give these patients conventional cosine solutions such as antagonist. In the first cycle, follicle stimulating hormone (FSH) starting dose of 225 ~ 300 iu is suggested to achieve plenty of ovarian stimulation for standards and maximize the benefits of superovulation. Because of the particularity of luteal support in the antagonist regimen, it is of great clinical significance to explore the trigger mode and combination mode of luteal support in the antagonist regimen for patients with poor prognosis.
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
- 21 Years 至 42 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age less than or equal to 42 years old, AFC<5 and or AMH<1.2ng/ml ② Adopt antagonist program for controlled ovulation hyperstimulation (COH); patients with fresh cycle transplantation;
- •Accept conventional IVF or intracytoplasmic sperm injection (ICSI);
- •The ART treatment cycle is less than 3 times.
排除标准
- •Abnormal chromosome karyotype;
- •Severe endometriosis;
- •Abnormal thyroid function; ④ Pregnancy contraindications; ⑤ Past history of ovarian tumors or after receiving radiotherapy
研究组 & 干预措施
Double trigger unit
HCG: 6000IU (Ovidrel: 250ug) + GnRH-a (Troprilin) 0.2mg
干预措施: Ovidrel (Drug)
Double trigger unit
HCG: 6000IU (Ovidrel: 250ug) + GnRH-a (Troprilin) 0.2mg
干预措施: Troprilin (Drug)
HCG trigger unit
HCG: 6000IU (Ovidrel: 250ug)
干预措施: Ovidrel (Drug)
结局指标
主要结局
Clinical pregnancy rate in each transplantation cycle
时间窗: 6 weeks
number of pregnant cases are confirmed by ultrasound/ total number of transplanted
次要结局
- Implantation rate(6 weeks)
- Rate of cancelled cycle(6 weeks)
- Number of mature eggs(6 weeks)
- Number of high-quality embryos(6 weeks)
- Early abortion rate(6 weeks)
- Cumulative pregnancy rate per stimulation cycle(6 weeks)
研究者
Li-jun Ding
Reproductive Medicine Center, Drum Tower Hospital Affiliated to Nanjing University Medical College
Nanjing University
