Comparison of Micro Dose Gonadotropin-Releasing Hormone (GnRH) Agonist Flare up & Flare Protocol in Poor Responders in Assisted Reproductive Technology (ART) Cycle
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
About 9 to 24 % of women undergoing in vitro fertilization (IVF) treatment respond poorly to the usual gonadotrophin stimulation protocol applied. Several induction ovulation treatments have been suggested for increasing pregnancy rate. In this study, the investigators will compare the outcome of Microflare protocol and Flare up regimen in poor responders.
详细描述
In this randomized clinical trial study, a total of 200 infertile women with poor ovarian response who undergo IVF / ICSI treatment cycle at Royan Institute will enroll in this study and will randomly be divided into two groups of 100 patients. This study has been approved by Royan ethics committee and written consent will be obtained from each patient.
The patients will be randomized to one of two groups of Flare Up or Microdose GnRh agonist flare up.
Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), Estradiol, will be evaluated on day 2 or 3 and when follicle size become >14.
2 weeks after embryo transfer, the patients will be tested for serum β-hCG for assessing the pregnancy. The clinical pregnancy will be clarified by the number of women with gestational sacs on transvaginal sonography at 4-6 weeks of gestation. In the calculation of implantation, the number of gestational sacs will be considered.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Poor responders (Presence of at least two of following items is necessary for inclusion to the study)
- •History of Cycle Cancellation
- •History of oocyte number 3 (in previous cycle)
- •History of Number of antral follicle < 5 in previous cycle
- •FSH>12 on day 2 or 3
- •Ovarian Volume 3 cm3
排除标准
- •Male factor (azospermi)
- •Myoma ≥6cm
- •One way ovary
- •Tumor or cyst >13mm
研究组 & 干预措施
Flare Up
Flare up protocol in poor responders for IVF/ICSI
干预措施: Flare up (Drug)
Microdose GnRh
Microflare protocol in poor responders for IVF/ICSI
干预措施: Microdose GnRh (Drug)
结局指标
主要结局
Live birth rate
时间窗: 12 months
次要结局
- Cycle cancellation rates(12 Months)
- Number of oocytes generated(12 Months)
- Number of embryos generated(12 Months)
- Implantation rate(12 Months)
- Pregnancy rate(12 months)