The Impact of a Single Dose of GnRH Agonist (Triptorelin 0,1 mg) at the Time of Implantation on the Reproductive Outcome in IVF Cycles Triggered by a GnRH Agonist Followed by a Small Bolus of HCG the Day of Oocyte Retrieval
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- implantation rate
研究概览
简要总结
Purpose:The aim of this project is to prospectively determine whether a single dose of GnRH-agonist administered at the time of implantation increases or not the reproductive outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic gonadotropin (hCG 1500 IU) the day of oocyte retrieval.
Acronyms:
GnRH: gonadotropin-releasing hormone FSH: follicle stimulating hormone LH: luteinizing hormone HCG:human chorionic gonadotropin IVF:In vitro fertilization ICSI:intracytoplasmatic sperm injection OHSS:ovarian hyperstimulation syndrome OMEGA: oocyte maturation employing GnRH-agonist OPU: ovum pick up NaCl: sodium chloride
详细描述
It has been reported in previous publications that the ovarian hyperstimulation syndrome (OHSS) was eliminated when GnRH agonist was used to trigger ovulation and the delivery rate has improved after modified luteal support especially when a small bolus of hCG is used on the day of oocyte retrieval. (OMEGA/HCG 1500 IU).
However, a risk difference of 7% in delivery rates is still in favor of HCG trigger. Thus, further modifications in the luteal phase supplementation are required in order to optimise the reproductive outcome after GnRH-agonist triggering.
Recently, many papers showed, that independently of the GnRH analogue used to prevent the premature LH surge, the addition of GnRH-agonist during the luteal phase seems to be beneficial in terms of pregnancy. Nevertheless, their use in practice is not yet admitted because of controversial results in terms of efficacy and safety particularly on the conceptus.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female age < 40 years
- •Baseline FSH and LH < 12 IU/l.
- •Body Mass Index > 18 and < 35 kg/m2
- •No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities
- •Patients with at least one embryo at transfer time
排除标准
- •Very high risk of OHSS (> 30 follicles > 12 mm the day of ovulation triggering).
- •Reduced ovarian reserve
- •Fertilization failure
- •Severe endocrinopathy
- •Azoospermia
研究组 & 干预措施
GnRH-agonist
Experimental Arm: Triptorelin 0.1 mg
干预措施: Triptorelin 0.1mg (Drug)
结局指标
主要结局
implantation rate
时间窗: 5 weeks after IVF/ICSI
number of gestational sacs per number of embryos transferred
次要结局
- chemical pregnancy(2 weeks after IVF/ICSI)
- live birth(26 weeks after IVF/ICSI)
- clinical pregnancy(5 weeks after IVF/ICSI)
研究者
benmachiche abdelhamid
Dr benmachiche abdelhamid, private infertility centre, Ibn rochd, constantine, Algeria
Centre Hospitalier Universitaire Ibn Rochd