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临床试验/NCT07499804
NCT07499804招募中4 期

Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月1日最近更新:
适应症

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

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

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

Sara Abdallah Mohamed Salem

Associate Professor of obstetrics and gynecology

Beni-Suef University

研究点 (1)

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