A Randomized Controlled Trial of Growth Hormone to Improve the Clinical Outcome of Assisted Fertility in Young Patients With Decreased Ovarian Reserve
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of embryos
研究概览
简要总结
This study was a prospective randomized controlled trial. Patients aged <35 years with decreased clinical reserve function (AFC<5, Follicle stimulating hormone > 10miu/ml, Anti-mullerian hormone < 1.1μg/L) and receiving IVF/ICSI assisted ovulation induction in our hospital were included in this study. After randomization using Excel(Microsoft Corporation, Albuquerque, USA), these patients were divided into two groups. Group A was the experimental group, which was treated with growth hormone for 3 months (2 units per day) before IVF/ICSI. Group B was the control group, which was directly assisted by IVF/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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age < 35 years;
- •Follicle stimulating hormone > 10miu/ml;
- •Anti-mullerian hormone < 1.1μg/L
- •(2 out of 2-4 items can be met)
排除标准
- •Severe male factors: spermatozoa collected by testicular sperm aspiration (TESA) or percutaneous epididymal sperm aspiration (PESA) was used for intracytoplasmic sperm injection (ICSI) cycle of single spermatozoa;
- •Patients with severe adenomyosis, endometriosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
- •Diabetes mellitus, insulin resistance;
- •chromosomal karyotype abnormality in either spouse;
- •Any pregnancy or contraindications of assisted reproductive technology;
研究组 & 干预措施
Growth hormone pretreatment+IVF/ICSI
After 3 months of Growth hormone treatment (2 units daily), IVF/ICSI was performed
干预措施: Growth hormone (Drug)
结局指标
主要结局
Number of embryos
时间窗: 4 months
When at least one dominant follicle reached a diameter of 18 mm or higher, 0.2 mg triptorelin was combined with 10000IU human chorionic gonadotropin as the trigger, and ovarian puncture was performed 36 hours later for oocyte retrieval. The number of embryos formed after three days of combined sperm and egg culture in vitro was recorded.
次要结局
- The number of oocytes retrieved(4 months)
- Clinical pregnancy rate(5-8months)
研究者
Li-jun Ding
Principal Investigator of Reproductive Medicine Center of The Affiliated Drum Tower Hospital of Nanjing University Medical Scho
Nanjing University