NCT02801591Unknown不适用
Effect of Recombinant Human Growth Hormone Injection on the Clinical Outcome of Poor Ovarian Response (POR) Clinical Outcome in Patients Undergoing in Vitro Fertilization / Embryo Transfer (IVF/ET)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
Observe the clinical efficacy and safety of Recombinant Human Growth Hormone Injection assisted in the treatment of the patients with poor ovarian response in vitro fertilization and embryo transfer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age 30-42 years old.
- •Diagnosis of POR (2011 ESHRE Bologna Standard).
- •At least two previous IVF failure history.
- •Voluntarily to sign the "informed consent".
排除标准
- •Severe acute and chronic liver and kidney disease，Such as liver cirrhosis, acute and chronic renal failure, hepatitis B virus activity period, etc.；Liver and kidney dysfunction.
- •Endocrine and metabolic diseases，eg, diabetes、Thyroid function hyperthyroidism, Thyroid dysfunction, cushing's syndrome, hyperprolactinemia，hyperandrogenism.
- •Related diseases affecting outcome of IVF pregnancy，eg, hydrosalpinx, hysteromyoma≥4cm, adenomyosis, stage III and IV endometriosis, untreated endometrial lesions, uterine malformation, genital tuberculosis, malignant tumor of reproductive system （include endometrial carcinoma, cervical carcinoma, ovarian cancer, fallopian tube carcinoma）.
- •Allergic to E. coli expression product and its excipients.
- •Subjects who participated in the past three months or are participating in other drug clinical researchers.
- •IVF failure history≥
- •The researchers consider who is not suitable for enrolling the group.
结局指标
主要结局
Clinical pregnancy rate
时间窗: One year
次要结局
- Number of retrieved oocytes(One year)
- Number of high quality embryos(One year)
- Number of embryos transferred(One year)
研究者
研究点 (2)
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