Effect of Polyethylene Glycol Recombinant Human Growth Hormone Injection on the IVF/ICSI Outcome of Patients With Poor Ovarian Reserve
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Live birth rate
研究概览
简要总结
Declined fertility and ovarian reserve in older women are associated with lower density of Growth hormone (GH) receptors and dysregulation in GH secretion. GH can regulate the expression of growth hormone receptor and strengthen the function of mitochondria, which could improve the quality of the female oocyte. In this study, a prospective randomized control will be conducted to explore the effect of GH adjuvant therapy on clinical outcome of in vitro fertilization.
详细描述
Eligible subjects will be randomly assigned into either the study groups (receive somatropin co-treatment) or the control group (without sopmatropin treatment). Polyethylene glycol recombinant human somatropin will be injected weekly (3mg/per week) for approximately 6 weeks, i.e. from the beginning of preceding menstruation cycle until the day of ovum pickup. Both groups will receive a similar common protocol for ovarian stimulation. In vitro fertilization with or without intracytoplasmic sperm injection will be performed according to semen parameters. All embryos will undergo culture for blastocyst and the obtained blastocysts will be vitrified for deferred frozen embryo transfer. The Blastocyst formation rate will be the primary outcome measure.
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 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Married women between 35-40 years old; 2) serum AMH< 1.2ng/ml, and basal FSH<20IU/L during the screening period or within 6 months; 3) 18kg/m2≤BMI<30kg/m2; 4) Previous ART cycles <3.
排除标准
- •1）Gynecological diseases that affect pregnancy outcomes, such as submucous uterine myoma, intramural uterine myoma≥4cm, Ovarian cyst≥4cm, endometriosis, Uterine malformation, Tuberculosis of reproductive system; 2) Spontaneous abortion≥3 times; 3) Chromosomal abnormalities (except polymorphism) in one or both spouses; 4) Patients with well-defined and uncontrolled endocrine, metabolic, and adrenal diseases, such as diabetes, thyroid disease, Cushing's syndrome; 5) Patients with malignant tumors; 6) Previous use of somatropin products.
研究组 & 干预措施
Growth Hormone group
Growth Hormone pretreatment for 6 weeks before ovarian stimulation
干预措施: Polyethylene Glycol Recombinant Human Somatropin (Drug)
结局指标
主要结局
Live birth rate
时间窗: One year
Blastocyst formation rate
时间窗: One year
the number of blastocyst/ the total number of embryos underwent blastocyst culture ×100%
次要结局
- Number of high-score embryos(One year)
- Ongoing pregnancy rate(One year)
- total amount of Gn used(One year)
- clinical pregnancy rate(One year)
- Endometrial thickness on triggering day(One year)
- Number of retrieved oocytes(One year)
- E2 levels on triggering day(One year)
- total days of Gn administration(One year)
研究者
Chen Zi-Jiang
Professor
Shandong University