Effects of Granulocyte - Macrophage Colony - Stimulating Factor (GM-CSF) Supplementation in Embryo Culture in Patients With Repeated Implantation Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ongoing pregnancy rate
研究概览
简要总结
The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with repeated implantation failure (RIF)
详细描述
60 patients with repeated implantation failure were involved.
RIF was defined as patients failed to conceive (beta-hCG < 5 mIU/mL) after at least 03 embryo transfers (fresh and frozen) with 06 top quality embryos or more.
Ovarian stimulation was performed using GnRH antagonist protocol. All matured oocytes were inseminated by ICSI. Injected oocytes were cultured in medium supplemented with 2ng/ml of GM-CSF (Embryogen, Origio) until day of transfer. Embryo evaluation was performed at fixed time points of 18 and 44 hour after fertilization. Embryo transfer was performed 2 days after ovum retrieval.
Luteal-phase support was provided using progesterone gel (Crinone 8% 90 mg, twice a day; Merck Serono) and estradiol per os (Valiera 2mg, twice a day; Laboratorios Recalcine). Serum hCG was measured 16 days after oocyte retrieval, and if positive, an ultrasound scan was performed at gestational weeks 7 and 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal ovarian reserve (AMH > 1.1 ng/ml)
- •Regular menstrual cycle (25 - 34 days)
- •Clear informations about at least 3 latest IVF/ET
- •Fresh embryo transfer in this cycle
- •Endometrial thickness of 10 mm or more
排除标准
- •Undergo oocyte donation or in vitro maturation (IVM) cycles
- •Using frozen or surgically retrieved sperm
- •Adenomyosis, Uterine anomaly, uterine fibroid, hydrosalpinges
- •In participation in other studies/interventions
结局指标
主要结局
ongoing pregnancy rate
时间窗: 12 week of gestation
次要结局
- Implantation rate(7 week of gestation)
- clinical pregnancy rate(7 week of gestation)
- top quality embryo rate(44 hours after insemination)
研究者
Dang Quang Vinh
Dr
Vietnam National University