Dual Trigger Versus Gonadotropin Releasing Hormone Agonist Trigger Combined With Luteal Human Chorionic Gonadotropin Administration
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
Comparing the reproductive outcomes of intracytoplasmic sperm injection (ICSI) cycles in women at risk of ovarian hyperstimulation syndrome (OHSS) subjected to gonadotropin releasing hormone (GnRH) antagonist protocol followed by trigger with concomitant GnRH agonist (GnRHa) and low-dose human chorionic gonadotropin (HCG) administration (dual trigger), GnRHa trigger with single luteal low-dose HCG or GnRHa trigger with multiple luteal low-doses HCG
详细描述
The GnRH antagonist fixed protocol will be used for controlled ovarian hyperstimulation (COH). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of the follicular growth (folliculometry). When there will be at least 3 leading follicles > 18 mm in diameter, women will be randomized into 3 groups; group A (dual trigger group), group B (single low-dose HCG group) and group C (multiple low-doses HCG group). In group A, final oocyte maturation will be triggered by dual administration of 0.2 mg of GnRHa preparation (Triptorelin) SC and 1500 IU of HCG preparation IM. In group B, final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then a single IM bolus of 1500 IU HCG will by administered 35-37 hours after GnRHa trigger (1 hour after oocyte retrieval). In group C, final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then 3 IM boluses of 500 IU HCG will be administered day 1, day 4 and day 7 after oocyte retrieval. In all women, oocyte retrieval will be performed 34-36 hours after trigger and endometrial preparation for embryo transfer (ET) will be started on the day of oocyte retrieval by giving 400 mg vaginal natural progesterone supplement once daily plus 4 mg oral estradiol valerate once daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRH antagonist.
- •Presence of risk for development of OHSS: 1) previous moderate or severe OHSS; 2) PCOS or polycystic ovary on ultrasound scan; 3) antral follicle count (AFC) > 14 in both ovaries; 4) basal serum AMH level > 3.36 ng/ml; 5) > 14 follicles with diameter of ≥ 11 mm on the day of triggering of oocyte maturation; 6) E2 level > 3000 pg/ml on the day of triggering of oocyte maturation.
排除标准
- •Age < 20 years or > 35 years.
- •BMI < 19 kg/m2 or > 35 kg/m
- •Moderate or severe endometriosis.
- •Hydrosalpinx.
- •Uterine abnormalities or myoma.
- •Previous uterine surgery.
- •Use of alternative techniques to minimize the risk of OHSS.
研究组 & 干预措施
Dual trigger group
Trigger with concomitant GnRHa and HCG (single low-dose) administration
干预措施: GnRHa and HCG (Drug)
Single low-dose HCG group
Trigger with GnRHa then HCG (single low-dose) administration in luteal phase
干预措施: GnRHa then HCG (single low-dose) (Drug)
Multiple low-doses HCG group
Trigger with GnRHa then HCG (multiple low-doses) administration in luteal phase
干预措施: GnRHa then HCG (multiple low-doses) (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 6 weeks after embryo transfer
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures
次要结局
- Incidence of early OHSS(Within 9 days of final triggering of oocyte maturation)
- Oocyte maturation rate(On day of oocyte retrieval)
- Implantation rate(6 weeks after embryo transfer)
- Miscarriage rate(12 weeks gestational age)
研究者
Mohamed Sayed Abdelhafez
Dr
Mansoura University