NCT03999541Unknown不适用
Fresh Versus Frozen Embryos for Infertility in the Poor Responders as Defined by the Bologna Criteria
Al-Yasmeen Fertility and Gynecology Center1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2019年7月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Livebirth rate
研究概览
简要总结
To compare the effects of fresh embryo transfers (ET) and elective frozen-thawed embryo transfer cycles in poor ovarian responders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Blinding of the allocated intervention is not possible.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients that fulfill the Bologna criteria [at least 2 of the following 3 features must be present: (i) advanced maternal age or any other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian reserve test (ORT)]
- •if the progesterone serum level was ≤1.5 ng/mL on the trigger day.
- •body mass index 18-32 kg/m2
- •Both partners are able to provide written informed consent.
- •At least 1 good quality embryo on day 3 after egg collection on day 3 according to the Istanbul consensus (7-8 cells; with symmetric blastomeres and <10% fragmentation by volume).
- •Endometrial thickness ≥8 mm on trigger day.
- •a normal uterine cavity on ultrasound.
- •IVF/ICSI with only fresh semen
排除标准
- •Pre-implantation genetic testing is being planned.
- •if they had severe endometriosis, uterine pathology (myomas, adenomyosis, endocrinopathies, adhesions, acquired or congenital abnormalities), untreated tubal hydrosalpinges, ovarian tumor, recurrent spontaneous abortion, implantation failure after ≥ 2 fresh or frozen ET.
结局指标
主要结局
Livebirth rate
时间窗: 32 weeks
The proportion of women in the population who had at least one live baby.
次要结局
- Pregnancy rate(2 weeks)
- Clinical pregnancy rate(6-8 weeks)
研究者
Yasmin Magdi
Director
Al-Yasmeen Fertility and Gynecology Center
研究点 (1)
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