NCT05602090招募中2 期
Effect of Growth Hormone Adjuvant Therapy on ICSI Trials For Poor Ovarian Reserve Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- pregnancy rate
研究概览
简要总结
Effect of Growth Hormone Adjuvant Therapy on ICSI Trials For Poor ovarian Reserve Patients
详细描述
To study the effect of growth hormone as adjuvant treatment on the outcomes of ICSI trials in poor ovarian reserve patients.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •According to Bologna criteria (((at least two )))of the following features must be present:
- •Advanced maternal age (40years).
- •A previous poor ovarian response with 3 oocytes retrieved after conventional stimulation
- •An abnormal ovarian reserve test (ORT)
- •antral follicle count (AFC)<7 or
- •anti-Müllerian hormone (AMH)<1.1ng/ml.
排除标准
- •Any known contraindications to the approved fertility drugs.
- •Any contraindications to growth hormone, pregnancy (to be ruled out and documented before GH treatment)
- •4- Hydrosalpinx 5- Uterine malformations or abnormal uterine cavity. 6- Basal FSH more than 17 IU. 7- Abnormal karyotyping 8- Partner with severe male factor 9- Uncontrolled endocrinopathies: DM, hyperthyroidism, hypothyroidism.
研究组 & 干预措施
Growth Hormone adjuvant treatment
Experimental
Growth hormone in this trial will use 4 IU of recombinant GH (Somatotropin, ) by day after day subcutaneous injection for 6 weeks before starting cycle. And on start day of induction ( Day 2 to 3) until the day of the human chorionic gonadotropin (hCG) trigger.
干预措施: 4 IU of recombinant GH (Somatotropin ) (Drug)
结局指标
主要结局
pregnancy rate
时间窗: ICSI trial (1month)
HCG positive
次要结局
未报告次要终点
研究者
Sara Abdallah Mohamed Salem
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University
研究点 (1)
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