Adjuvant Growth Hormone in Infertile Women With Prior Poor IVF Response: a Randomized, Controlled, Open-label Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Oocyte yield
研究概览
简要总结
This study (the "Adjuvant Growth Hormone Study") is being done to see the effects of adding Growth Hormone (GH) during fertility treatment (also called in vitro fertilization or IVF). Growth Hormone is a protein that your body normally produces. Growth Hormone can act on several different organs, including the ovaries, where eggs are made. From evidence gathered from studies done by fertility doctors over the years, researchers believe that women who have not become pregnant through IVF in the past might have better results if they go on a course of Growth Hormone during the IVF treatment. However, more research needs to be done to confirm whether adding Growth Hormone is beneficial and also to find out the best time to start Growth Hormone treatment during IVF.
We hope that our Adjuvant Growth Hormone study will help answer these questions.
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
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject with prior poor response(s) to ovarian stimulation for IVF or ICSI. Poor response is defined as a history of producing fewer than four follicles ≥14 mm in diameter during previous COS cycles where FSH or HMG was used from cycle start at a daily dose of ≥450 IU
- •Age ≤ 45 years
- •Baseline blood labs, measured within previous month, show fasting blood glucose <6.1 mmol/L and TSH ≤ 5.5 mU/L
- •Early follicular phase (Day 2 or Day 3) serum FSH, evaluated in the preceding 6 months
- •Subject willing and able to give informed consent
排除标准
- •Concurrently enrolled in any other clinical trial
- •Previous participation in this study
- •Using GnRH agonist in COS protocol
- •Any prior early follicular phase serum FSH level ≥12 IU/L
- •Use of any of the following is contraindicated or inappropriate: GH, Cetrotide®, FSH, LH or hCG
- •Used OCP within the prior month
- •Pregnant or lactating
- •Untreated hydrosalpinx
- •Tobacco smoker
- •Diabetic or otherwise at risk of gestational diabetes
- •BMI > 38 kg/m2
- •Poorly controlled thyroid disease
- •Known cancer or prior history of malignancies
研究组 & 干预措施
No Growth Hormone Supplementation
干预措施: No Saizen Control (Standard IVF Protocol) (Drug)
Luteal Growth Hormone Start
Growth hormone starting in the luteal phase of the previous menstrual cycle.
干预措施: Saizen (Human Growth Hormone) (Drug)
Follicular Growth Hormone Start
Starting growth hormone during the follicular phase of the prior menstrual cycle.
干预措施: Saizen (Human Growth Hormone) (Drug)
结局指标
主要结局
Oocyte yield
时间窗: Following course of treatment (2-3 weeks)
To assess the effect of adjuvant GH on the number of mature oocytes recovered from women undergoing COS using a GnRH antagonist protocol.
次要结局
- Pregnancy rate(Approximately 2 weeks following completion of treatment.)