Antagonist and Short Protocols in Invitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) Cycles With Delayed Embryo Transfer in Poor Ovarian Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Number of good embryos
研究概览
简要总结
Poor ovarian response indicates inadequate ovarian response to ovarian stimulation. In the current study the investigators will attempt to compare antagonist and short protocols regarding oocyte as well as embryo quantity and quality. Frozen embryo transfer will be performed in order to abolish iatrogenic effect of stimulation drugs on implantation. Still implantation and pregnancy rates are considered secondary outcomes.
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
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient selection is based on the ESHRE consensus group 2011 definition of poor ovarian response (POR) (Bologna criteria):
- •At least two of the following three features must be present:
- •Advanced maternal age (≥40 years) or any other risk factor for POR;
- •A previous POR (≤3 oocytes with a conventional stimulation protocol);
- •An abnormal ovarian reserve test (i.e. Antral follicle count (AFC) <5-7 follicles or Antimullerian hormone (AMH) <0.5-1.1 ng/ml).
- •Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal Ovarian reserve test (ORT). By definition, the term POR refers to the ovarian response and, therefore, one stimulated cycle is considered essential for the diagnosis of POR. However, patients over 40 years of age with an abnormal ORT may be classified as poor responders since both advanced age and an abnormal ORT may indicate reduced ovarian reserve and act as a surrogate of ovarian stimulation cycle. In this case, the patients should be more properly defined as expected PORs.
排除标准
- •Women with endometriosis, endocrinal problems, uterine abnormalities as well as male azospermia.
研究组 & 干预措施
Antagonist
Antagonist protocol (fixed) for IVF/ICSI, with starting dose of human menopausal gonadotrophins (HMG) from 300-450 IU from day 1 of the cycle, antagonist start from day 6 stimulation. Follow-up by ultrasound and serum estradiol will be done. Triggering of ovulation using human chorionic gonadotrophin (HCG) 10000 IU I.M. when at least 2-3 follicles reach 17mm in diameter.
Cryopreservation of all embryos at will be done. Frozen embryo transfer in the following cycle will be attempted using estradiol valerate (6mg) for endometrial preparation after pituitary down regulation using long acting GnRH analogue . A maximum of 3 good quality embryos will be transferred.
干预措施: IVF/ICSI (Procedure)
Short
Short protocol for IVF/ICSI, gonadotrophin releasing hormone analogue (GnRHa) starts from day 1 of the cycle, HMG starts in a dose from 300-450 IU from day 3, Follow-up by ultrasound and serum estradiol will be done. Triggering of ovulation using human chorionic gonadotrophin (HCG) 10000 IU I.M. when at least 2-3 follicles reach 17mm in diameter.
Cryopreservation of all embryos at will be done. Frozen embryo transfer in the following cycle will be attempted using estradiol valerate (6mg) for endometrial preparation after pituitary down regulation using long acting GnRH analogue . A maximum of 3 good quality embryos will be transferred.
干预措施: IVF/ICSI (Procedure)
结局指标
主要结局
Number of good embryos
时间窗: 3-5 days after ovum pickup
the number of good quality embryos obtained from each patient
Number of Metaphase II (MII) oocytes
时间窗: 9-14 days from stimulation
Number of MII oocytes collected from each patient on the day of ovum pickup (OPU)
次要结局
- clinical pregnancy rate(5 weeks after embryo transfer)
- Implantation rate(5 weeks after embryo transfer)
- Live birth rate(9 months)
- chemical pregnancy rate(14 days after embryo transfer)
- Ongoing pregnancy rate(3 months)
- Early miscarriage rate(3 months)