To Explore the Effect of Growth Hormone on Outcomes of in Vitro Fertilisation and Telomerase Activity of Granulosa Cells in Women With Poor Ovarian Response
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
It is still a big difficult clinical problem for patients with poor ovarian reserve undergoing in vitro fertilization. The decrease in both quality and quantity of egg are the main cause for poor clinical prognosis. Growth hormone (GH) is currently one of the main adjuvant for improving pregnancy outcomes in patients with POR, and the investigators' previous retrospective study suggested GH was effective in live birth rate in subgroup of patients with POR older than 35 years old. To further figure out the mechanism of GH effectiveness in POR patients and the effect on clinical outcomes in POR patients, the investigators designed this prospective observational cohort study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •For patients with poor ovarian response, the criteria is based on POSEIDON criteria[1]:
- •low ovarian reserve(AMH <1.2ng/ml, or AFC <5);
- •younger than
- •For patients with normal ovarian reserve, the criteria is as follow:
- •Patients who are between 20-40 years old;
- •clinical diagnosis of non-functional fallopian tube;
- •regular menstrual cycles.
排除标准
- •BMI ≥28kg/m2;
- •medical diseases such as endocrine and metabolic diseases, autoimmune disease, etc;
- •ovarian neoplasm that ≥4 cm in diameter and has no clear pathological diagnosis by surgery;
- •adenomyosis or endometriosis confirmed by surgery;
- •untreated abnormal intrauterine environment, such as uterine effusion, endometritis, etc;
- •untreated hydrosalpinx;
- •polycystic ovary syndrome.
研究组 & 干预措施
GH-POR
Participants diagnosed POR according to POSEIDON criteria with low ovarian reserve undergo IVF in our center with long protocol or antagonist protocol and is adjuvant with GH 2IU/d from previous menstrual period for about six weeks.
干预措施: growth hormone (Drug)
结局指标
主要结局
clinical pregnancy rate
时间窗: 1-2 years
Clinical pregnancy means pregnancy sac is seen intrauterine under ultrasound 7 weeks after embryo transferred.
次要结局
- number of oocytes retrieved(1-2 years)
- live birth rate(1-2 years)