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临床试验/NCT07016867
NCT07016867招募中不适用

Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment in Management of Male Subfertility With Isolated Teratozoospermia: A Prospective Randomized Study

South Valley University1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年9月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
126
试验地点
1
主要终点
Number of participants with Treatment of Teratozoospermia

研究概览

简要总结

A varicocele is defined as an abnormal venous dilatation and/or tortuosity of the pampiniform plexus in the scrotum. Although varicoceles are almost always and more common on the left side, up to 50% of the men with varicocele, have bilateral varicoceles.

Varicocele has a negative impact on spermatogenesis, testicular volume, Standard semen parameters, and fertilization, implantation, and embryo outcomes.

详细描述

Varicocelectomy remains the first-line treatment option in infertile men with palpable varicocele and abnormal semen parameters, with the microsurgical subinguinal approach conveying the greatest success rate and fewest complications. The empirical use of antioxidant supplement may confer some benefits in men to reduce oxidative damage.

Medical management, including antioxidants, could offer a potential solution with lower risks given the increasing evidence suggesting the role of oxidative stress in varicocele-induced infertility.

Physical examination of the scrotum remains the most commonly used technique to diagnose varicoceles. Palpation of the scrotum is best performed in a relaxed patient in standing position, in a warm room and carried out by a well-trained physician.

Surgical treatment of varicocele has a significant effect on semen parameters, so it is considered the 'gold standard' treatment for subfertile males with palpable varicoceles associated with abnormal semen analysis.

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 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Sub-fertile men with clinically palpable varicoceles ( unilateral or bilateral ).
  • Men with teratozoospermia.

排除标准

  • Recurrent varicoceles.
  • Significant medical diseases as: Hepatic insufficiency.
  • Hypersensitivity to the drugs.
  • Female factor of infertility.

研究组 & 干预措施

Group of l-carnitine and antioxidant

Active Comparator

About 42 male patients suffering from teratozoospermia will take medical treatment (l-carnitine and antioxidant) once daily for 3 months

干预措施: l-carnitine (Drug)

Group of varicocelectomy

Active Comparator

About 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy.

干预措施: l-carnitine (Drug)

Group of Mixed Treatment(varicocelectomy then l-carnitine and antioxidant)

Active Comparator

About 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy then adjuvant treatment (l-carnitine and antioxidant) for 3 months.

干预措施: l-carnitine (Drug)

结局指标

主要结局

Number of participants with Treatment of Teratozoospermia

时间窗: 3 months

Treatment of the male patients that suffering from abnormally shaped sperms (Teratozoospermia) by medical treatment and or subinguinal varicocelcetomy

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

Marwan Mohamed Ali

Resident of Urology, Faculty of Medicine

South Valley University

研究点 (1)

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