Optimal rhCG(Ovidrel®) Dose for Final Oocyte Maturation Triggering in Poor Responder During IVF and ICSI Cycles
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- oocyte maturity
研究概览
简要总结
Choriogonadotropin alfa (Ovidrel®) is a recombinant hCG (rhCG) preparation derived from genetically engineered Chinese hamster ovary cells, which is widely used for final oocyte maturation triggering in assisted reproductive technology (ART).Recombinant hCG has been investigated about its safety and efficacy comparing with urinary hCG, but still the optimal dose of rhCG is questionable. From former studies, there only have been proven that high dose of hCG can make ovarian hyperstimulation syndrome (OHSS) in usual condition. On the other hand, we hypothesize that high dose of hCG may improve oocyte maturity in poor responders who cannot easily provoke OHSS. Hence, this study will assess the comparative efficacy and safety of 250mcg and 500mcg of rhCG in ART treatment cycle.
详细描述
Randomized prospective clinical study that compare the two doses of rhCG (250mcg vs. 500mcg).
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
- 21 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •poor response in prior IVF cycle (≤ 4 oocyte retrieved)
- •women's age ≥ 40 years
- •FSH ≥ 10mIU/mL or AMH ≤ 1.1ng/mL
- •Antral follicle count <6
排除标准
- •patient without informed consent
研究组 & 干预措施
rhCG 250mcg
For final oocyte maturation triggering in ART, rhCG 250mcg will be administrated.
干预措施: recombinant hCG (Ovidrel®) (Drug)
rhCG 500mcg
For final oocyte maturation triggering in ART, rhCG 500mcg will be administrated.
干预措施: recombinant hCG (Ovidrel®) (Drug)
结局指标
主要结局
oocyte maturity
时间窗: Up to the ovum pick up day. At the point of ovum pick-up, we can count how many mature or immature oocytes were retrived. Therefore, in one hour after ovum pick-up, outcome measurement will be possible.
After administration of different doses of rhCG, oocyte maturity will be assessed on ovum pick up day. Oocytes will be classified into GV, MI, and MII.
次要结局
- clinical pregnancy rate(After confirming fetal heart beat via transvaginal ultrasound. Usually 2 to 4 weeks after ovum pick-up day.)
研究者
Seok Hyun Kim
Seok Hyun Kim
Seoul National University Hospital