A Randomized Open Three Arm Prospective Trial To Determine The Optimal Timing for Intrauterine Insemination After Superovulation With Recombinant Gonadotropins Utilizing GnRH Antagonists
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Achieving pregnancy
研究概览
简要总结
The timing of IUI following ovulation induction has been the subject of many studies and a consensus has developed that a single insemination approximately thirty-six hours after ovulation induction is sufficien. The introduction of GnRH antagonists preventing a premature LH surge and early ovulation has added a new dimension to fertility treatment. It allows greater accuracy in predicting the timing of ovulation and has been shown to be at least as effective, if not more effective, as ovarian stimulation without antagonists. We hypothesize that by utilizing GnRH antagonists we can increase pregnancy rates during IUI by timing the IUI as close as possible to the moment of ovulation guaranteeing the highest and freshest concentration of motile spermatozoa in the fallopian tube at the time the oocyte is released from the ovary. We therefore propose a randomized open three arm prospective trial utilizing superovulation with GnRH antagonists whereby the IUI is timed to take place 36, 42 or 48 hours after ovulation induction.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with infertility who are candidates for controlled ovarian stimulation and intrauterine insemination with
- •Ovulatory disorder
- •male factor
- •partial mechanical factor
- •endometriosis
- •unexplained infertility.
排除标准
- •Known allergy to one or more of the utilized drugs
- •Neither fallopian tube is patent
- •Sperm count less than 1 million total motile sperm of normal morphology during at least two investigations
- •Women who are candidates for mono-ovulation.
- •failure to receive consent
- •women with baseline functional cysts (i.e. hormone producing) above 12 mm diameter.
结局指标
主要结局
Achieving pregnancy
时间窗: 2 weeks after intervention
次要结局
- Live Birth(9 months after interventio)
研究者
Amir Weiss
Senior Physician
HaEmek Medical Center, Israel
