Efficacy of Growth Hormone Supplementation With Gonadotrophins in IVF/ICSI for Poor Responders; a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
The objective of this study is to assess the effectiveness of adjuvant growth hormone injection during controlled ovarian stimulation, in poor responder women undergoing intracytoplasmic sperm injection (ICSI) procedures.
详细描述
Infertility is defined as the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse (and there is no other reason, such as breastfeeding or postpartum amenorrhoea). Primary infertility is infertility in a couple who have never had a child. Secondary infertility is a failure to conceive following a previous pregnancy.
Subfertility, usually defined as the absence of conception after one year of regular intercourse, subfertility is a common problem affecting as many as one in six couples.
According to the European Society of Human Reproduction and Embryology (ESHRE) recommendations, couples with an estimated live birth rate of 40% or higher per year are encouraged to continue aiming for a spontaneous pregnancy .
Treatment methods for infertility may be grouped as medical, complementary and alternative treatments. Some methods may be used in concert with other methods. Drugs may be used for both women and men.
If conservative medical treatments fail to achieve a full term pregnancy, the physician may suggest the patient undergo assisted reproductive fertilization (ART). Methods for ART include artificial insemination (IUI), gamete intrafallopian transfer (GIFT), zygot intrafallopian transfer (ZIFT) or ICSI.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 25 to 38 years old.
- •IVF previous poor responders: at least two failed cycles with < five oocytes or abnormal ORT e.g. antimullerian hormone < 1
- •Patients with unexplained infertility.
- •Normal follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin and ovarian ultrasound.
- •Normal pelvic ultrasound including 3D ultrasound of the uterus with no detected hydrosalpinx.
排除标准
- •Refusal to participate in the study
- •Patients with known medical disease (e.g. severe hypertension or hepatic disease).
- •Altered karyotype in one or both partners.
- •History of chronic, autoimmune or metabolic diseases
- •Presence of endocrinopathies.
研究组 & 干预措施
Growth Hormones Somatropin Recombinant
Growth hormone (Somatropin) 4 IU/day subcutaneous from the 2nd day of the cycle and stopped 1 day before ovum pickup for the treatment group which consists of 70 women.
干预措施: Growth Hormones Somatropin Recombinant (Drug)
Placebo saline solution
Control group consisting of 70 women who will receive subcutaneous placebo injection in the same dosing as the treatment group
干预措施: Placebo saline solution (Drug)
结局指标
主要结局
clinical pregnancy rate
时间窗: 3 weeks
The main outcome is clinical pregnancy per allocated woman, defined as the presence of at least one fetus with heart beat.
次要结局
- E2 levels(Day 1 of COS, the same day of Human Chorionic Gonadotropin (HCG) injection)
- Multiple pregnancy(6 weeks from last period)
- Number of oocytes collected(Day 6 of COS)
- Metaphase I (MI) and Metaphase II (MII) oocyte number(Day 6 of COS)
- Number of Pronucleus(Day 6 of COS)
研究者
Emad Roushdy
Director
ClinAmygate