NCT04178135Unknown不适用
Recombinant LH Supplementation Timing Strategies (From Day 1 or Day 6) to a Standard GnRH Agonist Long Protocol in Subsequent COS Cycle of Older Patients With Unexpected Poor or Suboptimal Ovarian Response
Reproductive & Genetic Hospital of CITIC-Xiangya1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年12月25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
- 100
- 试验地点
- 1
- 主要终点
- Number of gestational sacs
研究概览
简要总结
A randomized, controlled, pilot study, for Patients ≥ 35 years and < 40 years old with sufficient ovarian reserve parameters (AFC≥ 5), but showed an unexpected poor or suboptimal ovarian response(defined as ≤ 9 retrieved oocytes in previous full-stimulation cycle, but not get live birth after all embryos were used ). In order to get better oocyte number and quality in the new COS cycle, we will compare LH supplementation from beginning with from middle of stimulation in GnRH-a long protocol.
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
- 35 Months 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1.Infertile women, 35≤ Age< 40 years 2.18<BMI<28 Kg/m2 3.5 ≤AFC ≤20 4.Basal serum FSH≤10 IU/L, E2<70 pg/ml 5.Previous cycle as the first COS cycle,AFC ≥ 5,starting dose of FSH between 150 IU and 300IU with the possibility of adding r-hLH or hMG later in the cycle, number of oocytes retrieved ≤9 (4-9 oocytes retrieval as suboptimal responder and <4 oocytes retrieval as unexpected poor responder), but not get live birth after all embryos were used.
- •6.Normal uterus and at least one side of the normal ovary 7.GnRH-a long protocol, using Gonal-F® 300IU and Luveris® 150IU for COS 8.Informed consent form signed 9.Willing to follow the study protocol, and able to complete this study
排除标准
- •Moderate and Severe endometriosis
- •Previous ovarian surgery history
- •History of recurrent miscarriages (>2 times of miscarriages)
- •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 other Gn other than Gonal-F® or Luveris® during COS treatment Thyroid gland disorders
研究组 & 干预措施
rLH supplementation from day 1 of stimulation
Experimental
rLH supplementation from day 1 of stimulation
干预措施: rLH (Drug)
rLH supplementation from day 6 of stimulation
Active Comparator
rLH supplementation from day 6 of stimulation
干预措施: rLH (Drug)
结局指标
主要结局
Number of gestational sacs
时间窗: Day 28 after embryo transfer
Number of gestation sac will be detected by ultrasonographic visualization
次要结局
未报告次要终点
研究者
研究点 (1)
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