Efficacy of Low Dose hCG on Oocyte Maturity for Ovarian Stimulation in Poor Responder Women Undergoing ICSI: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Number of mature oocytes
研究概览
简要总结
This study is a prospective, randomized, parallel, controlled trial to assess the efficacy of the late follicular phase administration of low dose hCG on oocyte maturity for ovarian stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (ICSI) treatment.
详细描述
In this study all eligible patients were randomly allocated into three study groups by a permuted block randomization method: group A (control group) received only recombinant FSH, group B received rFSH supplemented by 100IU hCG in the late follicular phase. Group C received rFSH supplemented by 200IU hCG in the late follicular phase.
All of the patients underwent a standard long protocol and received GnRH-a (Suprefact), 0.5cc subcutaneous, started from the day 17 of the preceding cycle and ovulation induction was started 14 days thereafter.
Patients were categorized according to the following stimulation protocols:
Group A (control group): which 300 IU r-FSH was administered for the first 5 days of the stimulation cycle. Then the first ultrasound scan was performed to monitor response. At this stage the dose of rFSH adjusted according to the ovarian response and continued until the day of ovulatory hCG administration.
Group B: rFSH supplemented with daily administration of 100 IU hCG in the late follicular phase based on the follicle size (14mm).
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
- 37 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Poor ovarian response to ovulation induction according to the ESHRE definition[20] and presence of at least 2 of the criteria needed to define poor responders including advanced maternal age, history of low ovarian response in previous IVF/ICSI treatments and abnormal ovarian reserve test(Antral Follicle number < 5)
- •indication for ICSI treatment, second or third cycle
- •Age 37 to 43 years
- •Body mass index (BMI) ≤ 30 kg/m2
- •The presence of two functional ovaries and no previous ovarian surgery
- •The presence of normal uterine cavity and 2 normal tubes base on recent hysterosalpingographic or hysteroscopic evaluation
- •Basal (day 2 or 3) serum FSH levels ≤13 IU/L
- •Normal semen analysis
- •No history or signs of endometriosis
- •No untreated endocrinologic disease
排除标准
- 未提供
研究组 & 干预措施
rFSH
Administration of recombinant FSH for ovarian stimulation.
干预措施: rFSH (Drug)
hCG(100IU)
Administration of late follicular low dose hCG(100U) for ovarian stimulation.
干预措施: hCG (Drug)
hCG(200IU)
Administration of late follicular low dose hCG(200IU) for ovarian stimulation.
干预措施: hCG (Drug)
结局指标
主要结局
Number of mature oocytes
时间窗: Up to 2 hours after oocyte retrieval
Evaluation the number of mature oocytes Up to 2 hours after oocyte retrieval
次要结局
- Number of retrieved oocytes(Up to 1 hour after oocyte retrieval)
- Number of generated embryos(Up to 48-72 hours after oocyte retrieval)
- Quality of generated embryos(Up to 48-72 hours after oocyte retrieval)
- Number of transferred embryos(on the time of embryo transfer)
- Quality of transferred embryos(on the time of embryo transfer)
- implantation rate(4 weeks after embryo transfer)
- chemical pregnancy rates(2 weeks after embryo transfer)
- clinical pregnancy rates(4 weeks after embryo transfer)