The Effect of Dual Trigger (GnRH Agonist + hCG) for Final Maturation in Oocyte Donors With History of a Previous Cycle With Suboptimal Response to GnRH Agonist Only Trigger
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Blastulation rate
研究概览
简要总结
The goal of this clinical trial is to compare GnRH-agonist trigger with dual GnRH-agonist and HCG trigger in oocyte donors.
The main questions it aims to answer are:
- Maturation rate (Metaphase II/ Total number of COCs collected)
- Fertilization rate
- Embryo quality day 3
- Fragmentation rate embryo day 3
- Blastulation rate (Day5/6/7)
- Quality of blastocyst (Gardner criteria) Participants will undergo controlled ovarian stimulation with a GnRH antagonist protocol Researchers will compare the effects of final maturation with GnRH-agonist trigger to a dual trigger (hCG and GnRH-a)
详细描述
Final oocyte maturation is a critical step in the process of the Assisted Reproductive Technology (ART) treatment and has a certain impact on oocyte yield and oocyte competency. There are three different types of trigger: hCG, GnRH-agonist or dual trigger (hCG and GnRH-agonist combined), and the choice depends on the ovarian stimulation protocol, the ovarian response and on the clinical standard of the IVF clinic. As oocyte donors are at high risk for OHSS, a GnRH-agonist trigger (GnRH-a) is the most commonly used modality for triggering final maturation. However, a certain number of oocyte donors may have a suboptimal response to GnRH-a trigger only, with a yield of oocytes less than the 10th percentile, with a clear negative impact on oocyte efficiency and competency. This study aims to evaluate whether oocyte competence can be improved in oocyte donors with a previously suboptimal response to GnRH-a, by using a dual trigger in a subsequent ovarian stimulation cycle, in which hCG is added to the GnRH-agonist for final maturation
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
- 20 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI: 18 - 25
- •AMH: 1-3ng/ml
- •Peak E2 in previous ovarian stimulation cycle: < 4000 pg/ml
- •Ovarian response in first stimulation cycle: < 20 follicles over 10mm in total, at time of triggering
- •Peak E2 in study cycle: < 4000 pg/ml
- •Suboptimal response to trigger medication at first stimulation cycle
- •Male age < 50 years old with normospermia
排除标准
- •Oocyte donors which are at risk for development of ovarian hyperstimulation syndrome (OHSS)
研究组 & 干预措施
Dual trigger (GnRH-agonist plus hCG)
Participants in this arm will be administered a GnRH-agonist trigger plus hCG (dual trigger) for final maturation
干预措施: Dual trigger (human chorionic gonadotropin plus GnRH-agonist) (Drug)
Gn-RH-agonist only trigger
Participants in this arm will be administered a GnRH-agonist trigger only for final maturation
干预措施: GnRH-agonist only trigger (Drug)
结局指标
主要结局
Blastulation rate
时间窗: 18 months prospective trial
Number of blastocysts up to day 6 per number of fertilised 2PN embryos
Oocyte maturation rate
时间窗: 18 months prospective trial
Number of metaphase II oocytes per total number of oocytes retrieved in oocyte pick-up day
Fertilization rate
时间窗: 18 months prospective trial
number of 2PN embryos per total number of MII oocytes fertilised
次要结局
- Number of recipients per donor cycle(18 months prospective trial)
- Ongoing Pregnancy Rate(28 months prospective trial)
- Live Birth Rate(28 months prospective trial)
研究者
Nikolaos Christoforidis
Consultant Obstetrician Gynaecologist - Clinical Director
Embryolab Fertility Clinic