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临床试验/NCT06718426
NCT06718426招募中不适用

Evaluation of Fertitonex Effects on Semen Parameters in Clinical Varicocele Patient, Placebo Controlled Study

Menoufia University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年12月1日最近更新:
适应症
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
110
试验地点
1
主要终点
Total sperm count

研究概览

简要总结

The aim of the study is to evaluate the Fertitonex effects on semen parameters in clinical varicocele patients.

详细描述

Infertility is defined as the inability of a couple to conceive after one year of unprotected, frequent and regular sexual intercourse. Almost 15% of all couples trying to conceive are affected by infertility, and in almost half of these cases male infertility is the sole or a contributing factor. The most common cause is idiopathic oligoasthenoteratozoospermia (OAT) that is defined as follows sperm concentration, the proportion of morphologically normal sperm and the proportion of motile sperm are all lower than the World Health Organization (WHO) reference values.

Despite extensive research, a successful treatment for OAT had not yet been developed. Small amounts of reactive oxygen species (ROS) are produced by spermatozoa in physiological conditions, and various scavengers act to reduce the concentration of these ROS in the seminal plasma. ROS are needed for capacitation, acrosome reaction and ultimately fertilization.

Antioxidants might help maintain the balance between ROS production and clearance and thus could improve sperm quality Additionally, observational studies had found a lower frequency of sperm aneuploidy in men with a higher dietary intake of antioxidants than in those with a lower intake. In semen, antioxidants decrease OS, potentially improving sperm motility and reducing DNA fragmentation.

We aim to evaluate the Fertitonex effects on semen parameters in clinical varicocele patients.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Primary infertility.
  • Abnormal semen analysis parameters.
  • Clinically evident varicocele confirmed by scrotal duplex.

排除标准

  • 2ry infertility.
  • Normal semen analysis parameters.
  • Clinically non-evident varicocele.
  • Past history of varicocelectomy.

研究组 & 干预措施

Fertitonex group

Active Comparator

Patients in this group will receive Fertitonex which contains L- carnitine L-tartarate 300 mg, L-arginine 241mg, vitamin B6 1.1 mg, vitamin B12 1.7 mcg, vitamin D3 2 mcg, vitamin E 6.5 mg, vitamin C 60 mg, selenium 28 mcg, zinc 7.5 mg, folic acid 300 mcg and CoQ 10 enzyme 7.5 mg in each capsule. The dose will be one capsule twice daily for 3 months.

干预措施: Fertitonex capsule (Drug)

Placebo group

Placebo Comparator

Patients in this group will receive placebo capsule twice daily for 3 months.

干预措施: Placebo Oral Capsule (Drug)

结局指标

主要结局

Total sperm count

时间窗: 3 months

Total sperm count will be assessed by Semen analysis done after 3 months of either fertitonex or placebo administration. Total sperm count will be measured by number of sperms present in the semen sample.

Sperm motility

时间窗: 3 months

Sperm motility will be assessed by semen analysis done after 3 months of either fertitonex or placebo administration. Both total motility will be measured by percentage of motile sperms and progressive motility will be measured by percentage of progressively motile sperms present in the semen sample.

Sperm Morphology

时间窗: 3 months

Sperm morphology will be assessed by semen analysis done after 3 months of either fertitonex or placebo administration. Sperm morphology will be measured by percentage of normally shaped sperms present in the semen sample.

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

Ammar Fathi Mohamed AlOrabi

Doctor

Menoufia University

研究点 (1)

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