Adjuvant Growth Therapy in in Vitro Fertilization: A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
In an In Vitro Fertilization (IVF) cycle super ovulating drugs (gonadotropins) are usually taken to stimulate the ovaries to produce more than one egg. In Vitro Fertilization protocols are constantly under review in order to improve the recruitment of the follicles, which contain the eggs, whilst minimizing the doses of gonadotrophins required, with the ultimate aim of increasing the live birth rate.
详细描述
The addition of growth hormone, which is a biological hormone that can be synthetically produced, as a supplement to gonadotrophins in an In Vitro Fertilization cycle has been suggested as a way in which In Vitro Fertilization pregnancy rates may be increased.Growth hormone has been shown, in animal and human studies, to be important in the recruitment of follicles.However, to date, only a limited number of clinical studies have been performed in order to assess whether the addition of growth hormone can improve the probability of pregnancy in women undergoing ovarian stimulation for In Vitro Fertilization. As the total number of patients analysed in these studies was small it has not been possible to determine whether if there is any improvement the outcome of an In Vitro Fertilization cycle when a woman is given growth hormone therapy as a supplement during her treatment.
This goal of this study is to determine the effectiveness of using growth hormone therapy as a supplement to the administration of gonadotropins in an antagonist In Vitro Fertilization protocol.
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
- 35 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 35 to 42
- •Primary or secondary infertility)
- •No previous treatment IVF cycle using the same proposed protocol
- •Negative pregnancy test at randomization (urine or blood)
排除标准
- •Contraindication to Saizen®
- •Simultaneous participation in another clinical trial
- •follicle stimulating hormone > 12 IU/L and/or anti-mullerian hormone < 0.5 pg/ml
- •Body mass index ≥ 35 kg/m2
- •Known risk of gestational diabetes
- •Administration of any investigational medication three months prior to study enrolment
- •Positive results of screening for either partner for HIV antibodies, Hepatitis B (other than surface antibodies present after vaccination) or Hepatitis C
- •Not able to communicate in French or English
研究组 & 干预措施
Growth Hormon
The participants randomized in the control group will be prescribed a regular antagonist IVF cycle with dose appropriate stimulation medication and will receive 2.5 mg of Adjuvant Growth Hormon (Saizen) daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering.
干预措施: Adjuvant Growth Hormon (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 7 weeks
To determine if the clinical pregnancy rate during the course of one treatment cycle in women receiving Growth Hormone daily in addition to gonadotropin-releasing hormone antagonist protocol is significantly higher than those receiving only gonadotropin-releasing hormone antagonist protocol (control group).
次要结局
- Total dose of gonadotropins(7 weeks)
- Oocyte morphology(7 weeks)
- Number of observed follicles(7 weeks)
- Number of mature (Metaphase II) oocytes retrieved(7 weeks)
- Embryo morphology(7 weeks)
- Implantation rate(7 weeks)
- Live birth rate(40 weeks)
- Fertilization rate(7 weeks)
- Adverse side effects in women(7 weeks)
- Embryo cleavage rate(7 weeks)
- Miscarriage rate(40 weeks)
- Number of embryos available(7 weeks)
- Number of supernumerary embryos available for cryopreservation(7 weeks)