Low-dose Growth Hormone Supplementation Increases Clinical Pregnancy Rate in Poor Responders Undergoing in Vitro Fertilisation.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 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 whether a low dose of GH supplementation (0.5 IU/day) increases clinical pregnancy rates in women with a history of POR who failed to become pregnant in two previous IVF cycles.
详细描述
The investigators aim to study the impact of a low-dose growth hormone (GH) supplementation in pregnancy rates in poor responders in a prospective, self-controlled study of 64 poor responders to previous IVF cycles who failed to achieve pregnancy and were supplemented with low-doses of GH in a subsequent cycle using the same gonadotropin dose and protocol. Our primary endpoint was the clinical pregnancy rate (CPR), considering secondary endpoints the number of retrieved oocytes, embryos, embryo quality and the proportion of cycles with embryo transfer.
Controlled ovarian hyperstimulation will be performed using a GnRH agonist long protocol from day 21-23 of the menstrual cycle at a dose of 1 mg/ day, using the same schedule and dose as in the previous cycle, so that the only difference between them is the GH supplementation.
After confirming pituitary inhibition, the dose of GnRH agonist will be decreased to 0.5 mg/day, and COH will begin with gonadotropins at a dose of 300 UI, subsequently adjusting according to clinical response. Human chorionic gonadotropin (hCG) will be administered when follicles reached > 17 mm in diameter. A dose of 0.5 IU of GH will be administered daily from the first day of the agonist until the day of hCG administration. Oocyte retrieval will be performed 36 hours after hCG administration by ultrasound-guided follicle aspiration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a history of POR, defined according to the Bologna criteria
- •Absence of pregnancy in at least two previous IVF cycles
排除标准
- •Body mass index ≥ 30 kg/m2
- •Presence of endocrinopathies
- •Altered karyotype in one or both partners
- •History of invasive ovarian surgery
- •History of chronic, autoimmune or metabolic diseases
- •Altered meiosis in testicular biopsy or altered sperm-FISH
- •Drug therapy in the male partner
- •Participation, within the previous 6 months, in another clinical trial with medication
研究组 & 干预措施
GH cycle
Subsequent IVF cycle, supplemented with a low dose of growth hormone.
干预措施: Growth Hormone (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 7 weeks of gestation
Presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound
次要结局
- Retrieved oocytes(On egg retrieval day)
- Number of obtained embryos(3 days after egg retrieval)
- Embryo quality(3 days after embryo transfer)
- Proportion of cycles with embryo transfer(3 days after egg retrieval)