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临床试验/NCT06491251
NCT06491251招募中不适用

Outcomes of Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility

Kafrelsheikh University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Effect of Infertility duration on sperm parameter and pregnancy rate after varicocelectomy

研究概览

简要总结

This study was conducted to assess the efficacy of varicocelectomy in unexplained male infertility with clinical varicocele The primary objective was to assess the pregnancy outcomes in these group. The secondary objective was to analyses improvement in Sperm DNA fragmentation , hormonal profile and semen parameter after varicocelectomy in Unexplained infertility .

详细描述

Infertility is defined as the absence of a desired pregnancy following regular, unprotected sexual intercourse for a period of at least 1 year. Over 15% of married couples worldwide experience fertility problems, and 50% of these cases are caused by male factor infertility.

Varicocele is the abnormal enlargement of the veins within the pampiniform plexus. The condition affects approximately 15% of the overall adult male population and 35% of men with primary infertility. Among men with secondary infertility, varicose veins are found in up to 80% of patients.

Only about 20% of all men with varicocele present with infertility. But overall, it is the most frequent abnormality found in infertile men.

Microsurgical varicocelectomy has gradually become the preferred surgical option for varicocele due to its advantages of less surgical damage, lower postoperative recurrence rate, fewer complications, higher postoperative semen quality, and higher postoperative fertility rate.

The two approaches to microsurgical varicocelectomy include the inguinal or subinguinal routes. The subinguinal approach involves the shallow spermatic cord and simple anatomic layers; it does not require the dissection of the external abdominal oblique muscle and allows for the application of spinal anesthesia.

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 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients unable to conceive after 12 month of regular and unprotected intercourse
  • Male patients aged 18 -45 years old
  • Normal semen analysis (concentration, motility and morphology) according to WHO criteria 2021
  • Infertile men with clinical varicocele (grade II,III) subjected to varicocelectomy
  • No history of other congenital or acquired urogenital diseases
  • Primary infertility
  • Normal BMI (18.5-24..9)

排除标准

  • History of other congenital or acquired urogenital diseases
  • Age outside inclusion criteria
  • Grade I varicocele confirmed by ultrasound ( subclinical varicocele )
  • Abnormal semen analysis
  • Recurrent varicocele
  • Patient unable or unwilling to comply with follow-up schedule
  • Female fertility issues (anovulation , hormonal infertility, tubal factor, endometriosis)

结局指标

主要结局

Effect of Infertility duration on sperm parameter and pregnancy rate after varicocelectomy

时间窗: follow up 1 year post varicocelectomy

The infertility duration is sub grouped into three according to months of primary infertility and measures changes in sperm concentration , motility ,morphology and changes in spontaneous pregnancy rate in different groups

varicocelectomy improved spontaneous pregnancy rates

时间窗: follow up 1 year post varicocelectomy

Sub inguinal microscopic varicocelectomy increase spontaneous pregnancy rates in groups with high sperm DNA fragmentation index in comparison to control group or varicocelectomy group with intermediate or normal sperm DNA fragmentation index

次要结局

  • Changes in sperm concentration , Motility and morphology after varicocelectomy(follow up 1 year post varicocelectomy)
  • Improvement in Sperm DNA fragmentation index(follow up 1 year post varicocelectomy)

研究者

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

Ahmed Abd El-Moaty Khalifa

Principle Investigator

Kafrelsheikh University

研究点 (2)

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