2025-524327-53-00招募中4 期
Luteal phase support following letrozole treatment in women undergoing intrauterine insemination: a multicenter randomized trial
Region Midtjylland8 个研究点 分布在 1 个国家目标入组 690 人开始时间: 2026年2月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 690
- 试验地点
- 8
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
To investigate if luteal phase support with a standard dose of vaginal progesterone increases the clinical pregnancy rates following mild ovarian stimulation with letrozole in infertile women undergoing IUI
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-37 years
- •Scheduled for intrauterine insemination with homologous or donor sperm
- •Undergoing mild ovarian stimulation with letrozole
- •Ability to provide written informed consent
排除标准
- •Age > 37 years
- •Anovulation due to hypogonadotropic hypogonadism
- •Known hypersensitivity to progesterone or to hard fat listed as an excipient in the Summary of Product Characteristics (SmPC) for Cyclogest.
- •Known or suspected progesterone-sensitive malignant tumours
- •Known missed abortion or ectopic pregnancy
- •Active arterial or venous thromboembolism, severe thrombophlebitis, or a history of these conditions
- •Severe hepatic dysfunction or liver disease
- •Inability to speak or understand Danish sufficiently to comprehend oral and written study information
研究组 & 干预措施
Cyclogest 400 mg vagitorier
Test
干预措施: Cyclogest 400 mg vagitorier (Drug)
结局指标
主要结局
Clinical pregnancy rate
Clinical pregnancy rate
次要结局
- Live birth rate
- Biochemical pregnancy rate
- Early pregnancy loss
- Fetal miscarriage
- Perinatal outcomes: preterm birth, birth weight, congenital malformation, perinatal mortality
- Obstetric outcomes: hypertensive disorders of pregnancy, gestational diabetes, postpartum hemorrhage and cesarean section
- Hormone levels measured on the day of insemination, mid-luteal phase and ovulation trigger (optional)
研究者
Kirstine Kirkegaard
Scientific
Region Midtjylland
研究点 (8)
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