NCT03966339Unknown不适用
Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality：a Randomized Controlled Study
Reproductive & Genetic Hospital of CITIC-Xiangya1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2019年8月1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
- 128
- 试验地点
- 1
- 主要终点
- proportion of high-quality embryos at D3
研究概览
简要总结
GH plays an important role in the synthesis of ovarian steroid hormone and follicular development as a paracrine hormone.GH can regulate the growth hormone receptor and strengthen the function of mitochondria to improve the quality of the female oocyte.In this study, a prospective randomized control was used to explore the effect of GH adjuvant therapy on embryo quality.
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
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •infertility women whose age ≥20 and ≤39 years old; 2)women has done IVF/ICSI assisted treatment ≥1 times； 3)number of IVF/ICSI assisted treatment cylces with ≥6 oocytes retrieved ≥1； 4)number of IVF/ICSI assisted treatment cylces with ≥50% fertilization rate ≥1 ; 5)historical assisted reproduction cycles without ≥6C-Ⅱ level embryos at the third day after oocytes retrieval or without blastocyst formation after blastocyst culturing.
排除标准
- •Diseases related to IVF treatment outcome, such as untreated hydrosalpinx, uterine fibroids affecting uterine cavity, myometriosis, endometrial lesions, obvious uterine abnormalities,etc; 2)Severe acute or chronic liver or kidney diseases, such as cirrhosis, acute or chronic renal failure, hepatitis B virus activity period,etc.;in patients with abnormal liver and kidney function, the AST or ALT detection value was 2.5 times higher than the upper limit of normal, and the serum creatinine was 2 times higher than the upper limit of normal.
- •Endocrine and metabolic diseases and adrenal diseases, such as diabetes, Cushing's syndrome,etc.; 4)People has allergy history of growth hormone product; 5)Participating in other clinical research; 6)Other conditions that researchers determined not fit to be enrolled.
研究组 & 干预措施
GH group
Experimental
Growth Hormone adding to controlled ovarian hyperstimulation
干预措施: Growth hormone (Drug)
结局指标
主要结局
proportion of high-quality embryos at D3
时间窗: the third day after oocyte retrieval
proportion of embryos grading 6C-II and above 6C-II at the third day after oocyte retrieval
number of high-quality embryos at D3
时间窗: the third day after oocyte retrieval
number of embryos grading 6C-II and above 6C-II at the third day after oocyte retrieval
次要结局
- number of high-quality oocytes(four months)
- total days of Gn used(two months)
- E2 levels at triggering day(four months)
- clinical pregnancy rate(28 days after embryo transplanted)
- total amount of Gn used(four months)
- implantation rate(28 days after embryo transplanted)
- IGF-I level at the first day of injecting Gn and before injecting Gn(at the first day of injecting Gn and before injecting Gn)
- IGF-I level at triggering day(four months)
- number of blastocysts at the fifth,sixth or seventh day after oocyte retrieval(at the fifth,sixth or seventh day after oocyte retrieval)
- IGF-I level at the first day of injecting GH and befor injecting GH(GH group)(at the first day of injecting GH and befor injecting GH(GH group))
研究者
研究点 (1)
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