跳至主要内容
临床试验/NCT05951413
NCT05951413招募中2 期

The Effect of Sildenafil Citrate on the Endometrial Thickness and Pregnancy Rates of Frozen Embryo Transfer Cycles

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年6月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
110
试验地点
1
主要终点
endometrial thickness

研究概览

简要总结

to investigate the value of adding sildenafil citrate during endometrial preparation in patients undergoing frozen-thawed embryo transfer and its effect on endometrial thickness and pregnancy rates.

详细描述

Patients who met these conditions entered the study and 110 patients will be divided into two groups 55 patients in each group based on randomized tables.

Group 1: will be given estradiol in form of Cycloprogynova 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: will be given sildenafil citrate tablets (50 mg) daily in addition to the above treatment protocol from the first day of the cycle until the day of starting progesterone. It was discontinued 48- 72 hours prior to the embryo transfer.

On the ninth day of the menstrual cycle, the endometrial thickness will be estimated by transvaginal ultrasonography (arranged in a series every other day). The evaluations will be performed by a single investigator.

If the endometrial thickness was more than 8mm, 400 mg of progesterone vaginal suppository and Duphastone tabs twice daily will be administered.

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
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age under 40 years
  • Subject has high quality frozen embryos

排除标准

  • 1-A history of endocrine diseases.
  • A history of any previous surgery that could compromise the integrity of endometrium.
  • Cardiovascular, renal and liver diseases.
  • Hypotension (blood pressure less than 90/50).
  • A history of stroke or myocardial infarction.
  • A history of previous implantation failure.

研究组 & 干预措施

Sildenafil

Experimental

patients will be given estradiol in form of Cycloprogynova 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 and will have will be given sildenafil citrate tablets (50 mg) daily .

干预措施: Sildenafil Citrate (Drug)

Sildenafil

Experimental

patients will be given estradiol in form of Cycloprogynova 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 and will have will be given sildenafil citrate tablets (50 mg) daily .

干预措施: estradiol (Drug)

control

Placebo Comparator

patients will be given estradiol in form of Cycloprogynova 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.

干预措施: estradiol (Drug)

结局指标

主要结局

endometrial thickness

时间窗: 10 to 16 days from start of cycle

endometrial thickness measured by transvaginal ultrasound

次要结局

  • pregnancy rate(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Abdallah Mohamed Salem

Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Beni-Suef University

研究点 (1)

Loading locations...

相似试验