Effect of Vaginal Sildenafil Citrate on Endometrial Preparation and Outcome in Frozen Thawed Embryo Transfer Cycles
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- endometrial thickness
研究概览
简要总结
A total of 80 Patients who meet these conditions will enter the study and be divided into two groups based on randomized tables.
To prepare the endometrium,
Group A : 40 women are given oral estradiol valerate tablets 2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium
Group B : 40 women are give sildenafil citrate 25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle, in addition to oral 2mg of estradiol valerat 6-8 hourly from the day 2-14 of the menstrual cycle . Estrogen and progesterone (prontogest 400mg pessaries ) are given 3 days prior to embryo transfer. Sildenafil is discontinued 48-72 hours prior to the embryo transfe due sildenafil may have some detrimental effects on endometrium in the implantation window
详细描述
A total of 80 Patients who meet these conditions will enter the study and be divided into two groups based on randomized tables.
To prepare the endometrium,
Group A : 40 women are given oral estradiol valerate tablets 2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium
Group B : 40 women are give sildenafil citrate 25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle, in addition to oral 2mg of estradiol valerat 6-8 hourly from the day 2-14 of the menstrual cycle . Estrogen and progesterone (prontogest 400mg pessaries ) are given 3 days prior to embryo transfer. Sildenafil is discontinued 48-72 hours prior to the embryo transfe due sildenafil may have some detrimental effects on endometrium in the implantation window.
For assessing endometrial vascularity (on day 14 of cycle), two dimension power Doppler characteristics as normal quality of color, color gain-3.4, pulse repetition frequency of 600Hz and wall motion filter of 50Hz are applied in all examinations. By following Applebaum's zones of vascularity for categorizing endometrial vasculaity: Zone 1 vascularity-When blood vessls reach the hypoechoic endometrio-myometria junction, Zone 2 vascularity when the vessels reach the outer hyperechoic line of en-dometrium, Zone 3 vascularity when it reach the intervening hypoechoic area, Zone 4 vascularity when the vessels are seen reaching the central echogenic line .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing their first frozen embryo transfer cycle.
- •have at least two high quality frozen embryos
排除标准
- •a history of endocrine diseases.
- •a history of hysteroscopic surgeries.
- •cardiovascular, renal and liver diseases.
- •hypotension (blood pressure <90/50 mmHg).
- •a history of stroke or myocardial infarction.
研究组 & 干预措施
Sildenafil group
40 women are give sildenafil citrate 25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle, in addition to oral 2mg of estradiol valerat 6-8 hourly from the day 2-14 of the menstrual cycle
干预措施: sildenafil citrate (Drug)
Sildenafil group
40 women are give sildenafil citrate 25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle, in addition to oral 2mg of estradiol valerat 6-8 hourly from the day 2-14 of the menstrual cycle
干预措施: Estradiol Valerate 2 MG (Drug)
estradiol group
40 women are given oral estradiol valerate tablets 2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium in addition to placebo in the same way as sildenafil
干预措施: Estradiol Valerate 2 MG (Drug)
结局指标
主要结局
endometrial thickness
时间窗: At the day of embryo transfer
ultrasound measurement of the endometrial thickness at the fundus
次要结局
- Endometrial vascularity(At the day of embryo transfer)
- clinical pregnancy rate(4 weeks after embryo transfer)
研究者
Ahmed M Maged, MD
Principal investigator
Cairo University
