Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pregnancy
研究概览
简要总结
investigate the effect of different vasodilators as Tadalafil in women with unexplained infertility using IVF
详细描述
This prospective randomized clinical study was carried out on 100 women, aged <18 to 43 years old, has good quality day five frozen embryos. The study was done after approval from the Ethical Committee Beni Suef University Hospitals, Beni Suef, Egypt. An informed written consent was obtained from the patients.
Randomization and blindness:
An online randomization program (http://www.randomizer.org ) was used to generate a random list and each patient's code was kept in an opaque sealed envelope. Patients were randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner: Group 1 (control): Patients received estradiol valerate 2 mg. in form of (Cycloprogynova® Bayer Shering Pharma) white pills starting dose is one pill T.I.D may be increased to two pills T.I.D according to endometrial thickness in day 9 measured by vaginal ultrasound.
Group 2: received tadalafil 5 mg. once daily in form of (tadanerfi 5® Nerhadou international5 co.) daily in addition to the above treatment protocol from the first day of the cycle until the day of starting progesterone. All patients were subjected to complete history taking, general examination, laboratory investigations [Anti-müllerian hormone (AMH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E₂), prolactin (PRL) and thyroid-stimulating hormone (TSH)] and radiological investigations [Ultrasonography].
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 43 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •has good quality day five frozen embryos.
排除标准
- •hypotension (blood pressure less than 90/50) and
- •history of stroke or myocardial infarction
结局指标
主要结局
pregnancy
时间窗: 1 month
whom Beta-Human Chorionic Gonadotropin (β-hCG) was positive
次要结局
未报告次要终点
研究者
Sara Abdallah Mohamed Salem
Associate Professor of obstetrics and gynecology
Beni-Suef University
