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临床试验/NCT05616000
NCT05616000已完成2 期

Comparison of Acetyl- L- Carnitine and Folic Acid Versus Coenzyme Q10 and Folic Acid on Semen and Hormonal Parameters and Semen Oxidative Status in Patients of Primary Infertility. A Double Blind Randomized Clinical Trial

Khyber Medical University Peshawar1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2022年8月6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
已完成
发起方
入组人数
86
试验地点
1
主要终点
change in semen analysis before& after the administration of antioxidants& folic acid.

研究概览

简要总结

The investigators aim is to conduct a double blind randomized clinical trial, to study the effects of Acetyl-L-Carnitine and folic acid versus Coenzyme Q10 and folic acid on Semen and hormonal parameters and semen oxidative stress in patients of Primary infertility. Males diagnosed with Primary Infertility are recruited in the study after fulfilling the inclusion nd exclusion criteria. The investigators propose that Primary infertile men may have altered seminal oxidative status & the combinational therapy may achieve favorable seminal , hormonal& antioxidant levels in men having Primary infertility.

详细描述

Historically, male infertility was considered a taboo subject and its role was deliberately kept in dark until recently when with advances in medical science, the issue was highlighted and its role came into limelight in couple's infertility. Male infertility is mainly caused by oxidative stress. O2- (superoxide anion), OH- (hydroxyl ions), H2O2 (hydrogen peroxide), nitric oxide & ROO- (peroxyl) radicals are all oxygen derived highly reactive oxygen species with a free unpaired electron in their outer orbit making them short lived, highly reactive & unstable. They are produced by the sperms & their normal level help in the sperm maturation, motility, capacitation & facilitation of fertilization. Sperms are at risk of the damage caused by overproduction of these ions. Several factors have been implicated in the overproduction of these reactive oxygen species which include men with testicular hyperthermia (varicocoele, cooks, and drivers) & overproduction by immature sperms & leucocytes. Their overproduction cause damage to the DNA and peroxidation of the lipid membrane leading to detrimental effects on sperms causing infertility There has been no consensus on treatment of male infertility in literature. No standardized treatment is suggested and different treatment combinations are currently been used to manage male infertility. The role of CoQ10 & Acetyl- L-Carnitine is explored recently in the different studies with no consensus on their dosage, duration of treatment & their effect on serum testosterone. This study is conducted to find out the role of Acetyl- L-Carnitine and Co enzyme Q 10 in combination with folic acid and their effect on semen parameters, semen oxidative stress & serum testosterone level in treating primary infertile men.

Objective

To find the effects of Acetyl-l-Carnitine and folic acid versus Coenzyme Q10 and folic acid therapy on sperm parameters, seminal oxidative status & serum testosterone level in primary infertility male 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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Treatment naïve primary male infertile patients with Oligospermia, Asthenozoospermia , Teratozoospermia & Necrozoospermia
  • Aged between 20 - 45 years
  • Married for more than a year with regular intercourse minimum 3/week.
  • Normal female partner with normal menstrual cycle

排除标准

  • Azoospermic patients
  • Patients with varicocoele
  • Erectile dysfunction
  • Secondary infertility
  • Patients already taking treatment for primary infertility

研究组 & 干预措施

Acetyl-L-Carnitine group

Experimental

Acetyl-L-Carnitine (2gm once a day), folic acid 5mg (once a day) 43 Patients with Primary Infertility will receive Acetyl-L-Carnitine (2gm once a day) orally& folic acid 5mg orally was given to all the participants of this group (once a day).

干预措施: Acetyl-l-carnitine, folic acid (Drug)

Control group

Experimental

Coenzyme Q10 (400mg once a day) orally was given to all participants& folic acid 5mg (once a day) was also given orally to these participants 43 Patients with Primary Infertility will receive Coenzyme Q10 (400mg once a day), folic acid 5mg (once a day).

干预措施: Acetyl-l-carnitine, folic acid (Drug)

结局指标

主要结局

change in semen analysis before& after the administration of antioxidants& folic acid.

时间窗: it will be done at the start of the trial and then after 3 months

semen analysis of the patients will be done and sperm count million/ml, motility, grading of motility(grade from 0 to 4), volumein ml will be analyzed.

change in serum testosterone in nanograms/dl before& after the administration of antioxidants& folic acid.

时间窗: it will be done at the start of the trial and then after 3 months

serum testosterone levels of the patients will be analyzed through commercially available Elisa kits

change in seminal oxidative status before& after the administration of antioxidants& folic acid.

时间窗: it will be done at the start of the trial and then after 3 months

seminal plasma of the primary infertile men will be analyzed for total antioxidant capacity(TAC)\& superoxide dismustase levels through commercially available Elisa kits.

次要结局

未报告次要终点

研究者

发起方
Khyber Medical University Peshawar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohsin Shah

Associate Professor

Khyber Medical University Peshawar

研究点 (1)

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