Comparison Between Agonist Trigger With HCG Luteal Phase Supplementation vs HCG Trigger With Progesterone Luteal Phase Supplementation in Antagonist Controlled HyperstimulationCycle Regarding Clinical Pregnancy Rate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The aim of the current study is to compare agonist trigger and HCG luteal support vs standard HCG trigger and progesterone luteal supplementation in antagonist controlled hyperstimulation cycle as regards to clinical pregnancy rate.
详细描述
Prospective Interventional randomized pilotstudy on patients undergoing controlled ovarian hyperstimulation.
All patients will receive a fixed dose of 150-300 IU recombinant FSH (Gonal-F; Sereno Laboratories,Madrid, Spain) for ovarian stimulation according to age, BMI and antral follicle count (AFC).
After 6 days of stimulation, FSH will be adjusted according to ovarian response.
Premature LH surge will be prevented with 0.25 mg of a GnRH antagonist (Cetrotide; Serono International, Geneva, Switzerland) starting on day 6 when two or more follicles reach a size of 18-20 mm, trigger of ovulation will be done and followed by luteal phase support according to the protocol assigned for each group.
Group 1:
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 39 years.
- •Body mass index between 18 and
- •Unexplained infertility or male factor infertility
排除标准
- •Endocrinological disorder eg.:hyperprolactenemia, Hypo or hyper thyrodism
- •More than 2 previous attemptsof IVF
- •Any uterine anatomical anomaly.
研究组 & 干预措施
Group 1
They will receive a single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections
干预措施: hCG (Drug)
Group 1
They will receive a single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections
干预措施: Triptorelin (Drug)
Group 2
They will receive a single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).
干预措施: hCG (Drug)
Group 2
They will receive a single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).
干预措施: Progesterone (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 1 year
Clinical pregnancy diagnosed by pregnancy test and ultrasound
次要结局
未报告次要终点
研究者
maii medhat nawara
Principal investigator
Ain Shams University