Which is the Best IVF/ICSI Protocol to be Used in Poor Responders Receiving Growth Hormone as an Adjuvant Treatment ? A Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 287
- 试验地点
- 1
- 主要终点
- Numbers of oocytes retrieved and number of fertilized oocytes
研究概览
简要总结
in this study, we are trying to monitor the effect of the addition of growth hormone on the different down regulation protocols ( long, short, antagonist and microflare). The outcome will be primarily assessed by the clinical pregnancy rates.
详细描述
Poor responders undergoing IVF/ICSI cycles have emerged as a major problem. the need to find a proper stimulation protocol is a must. in this study we are trying to detect the best stimulation protocol ,in addition to growth hormone ,that can give the highest pregnancy rates in these 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ESHRE consensus 2011,At least two of the following three features must be present:
- •Advanced maternal age (≥40 years) or any other risk factor for POR;
- •A previous POR (≤3 oocytes with a conventional stimulation protocol);
- •An abnormal ovarian reserve test (i.e. AFC < 5-7 follicles or AMH < 0.5 -1.1 ng/ml).
排除标准
- •female patients with causes of infertility other than poor ovarian reserve
- •females suffering from congenital or acquired uterine anomalies
- •females with focal uterine lesions
- •females who had previous ovarian surgeries
- •females with history of previous exposure to radiotherapy , or chemotherapy
- •females refusing to get enrolled in the study
研究组 & 干预措施
The Long protocol
Patients in the group A received a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) which started on day 21 of preceding cycle at a dose of 0.1 mg/day. On the second day of menstruation HMG was started and this was associated with reduction of triptorelin to 0.05 mg/day. This reduced daily dose was administered until the day hCG was given. Growth hormone co-treatment was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.
干预措施: Growth hormone (Norditropin, Novo nordisk) (Drug)
The Short protocol
The short agonist protocol was started on cycle day 1 with triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. Human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) were also administered starting from days 2 to 3 of cycle. The dose was adjusted for each patient according to the diameter of the follicles detected in their follow up ultrasound. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.
干预措施: Growth hormone (Norditropin, Novo nordisk) (Drug)
The Antagonist protocol
Gonadotrophins IM daily (HMG 75 IU, Merional, IBSA)was administrated from day 2 of the cycle. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration. The GnRH antagonist (Cetrotide) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC.
干预措施: Growth hormone (Norditropin, Novo nordisk) (Drug)
The Microflare protocol
the patients in this group were given oral contraceptive pills (OCPs) for 28 days, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) 3 days later. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.
干预措施: Growth hormone (Norditropin, Novo nordisk) (Drug)
结局指标
主要结局
Numbers of oocytes retrieved and number of fertilized oocytes
时间窗: 2 years
Number of oocytes retrieved on the day of vaginal egg collection guided by trans vaginal ultrasound scan , 35 hours after hCG administration.
次要结局
未报告次要终点
研究者
Dina Mohamed Refaat Dakhly
lecturer of obstetrics and gynecology, cairo university
Woman's Health University Hospital, Egypt