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临床试验/NCT04717752
NCT04717752Unknown不适用

A Randomized Controlled Study of Different Trigger Modes of Antagonist Regimen in Patients With Low Ovarian Reserve

Nanjing University1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2021年1月20日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

HCG: 6000IU (Ovidrel: 250ug) + GnRH-a (Troprilin) 0.2mg

干预措施: Ovidrel (Drug)

Double trigger unit

Experimental

HCG: 6000IU (Ovidrel: 250ug) + GnRH-a (Troprilin) 0.2mg

干预措施: Troprilin (Drug)

HCG trigger unit

Sham Comparator

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

发起方
Nanjing University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Li-jun Ding

Reproductive Medicine Center, Drum Tower Hospital Affiliated to Nanjing University Medical College

Nanjing University

研究点 (1)

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