NCT02801565Unknown不适用
Clinical Observation of Recombinant Human Growth Hormone Injection Assisted in Vitro Fertilization and Embryo Transfer (IVF-ET) in the Treatment of Polycystic Ovary Syndrome (PCOS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
Observe validity of Recombinant Human Growth Hormone Injection assisted in IVF-ET (in vitro fertilization and embryo transfer) treatment of PCOS (polycystic ovary syndrome) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 25 and 35 years old, married female and infertile.
- •BMI≥25kg/m
- •Diagnosed as PCOS.
- •No obvious chronic organic diseases, such as liver, kidney, heart, lung, thyroid, adrenal disease.
- •Subjects do not take part in other clinical trial study within 3 months.
- •The subjects sign the informed consent form.
排除标准
- •BMI<25kg/m
- •Hyperprolactinemia and congenital adrenal cortical hyperplasia.
- •Diabetes, thyroid function hyperthyroidism, thyroid dysfunction, cushing's syndrome.
- •Pelvic and peritoneal tumor and tumor secreting hyperandrogenism.
- •Severe acute and chronic liver and kidney disease, such as liver cirrhosis, acute and chronic renal failure, hepatitis B virus activity.
- •Liver and kidney dysfunction, AST/ALT is 2.5 times higher than the normal limit, the serum of creatinine is 2 times higher than the normal level.
- •Diseases affecting outcome of IVF pregnancy, eg, hydrosalpinx, hysteromyoma>4 cm, adenomyosis, endometriosis, endometrial cyst of ovary, unilateral ovary, tuberculosis of reproductive system.
- •Allergic to E. coli. expression product and its excipients.
- •Being involved in other drug clinical researchers.
- •The researchers consider who is not suitable for the group.
研究组 & 干预措施
GH AQ
Experimental
Controlled ovarian stimulation in the middle of the corpus (D21 days) of the previous menstrual cycle to use recombinant Human Growth Hormone Injection（rhGH） Injection 15IU/5mg/3mL/cartridge, 5IU per day, Subcutaneous injection after 20:00 until the HCG trigger day.
干预措施: Conventional controlled ovarian stimulation proctol (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: One year
Number of fertilized oocytes
时间窗: One year
次要结局
- Number of high quality embryos(One year)
- Number of transferred embryos(One year)
- Number of retrieved oocytes(One year)
研究者
研究点 (1)
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