Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram and Sex Hormone in Iraqi Infertile Men; A Comparative Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- The seminal fluid analysis
研究概览
简要总结
Worldwide infertility affects about 15 % of reproductive-age couples. In many cases, infertility can't be treated, new treatment options with promising value were involved in the recent clinical trials.
详细描述
We will evaluate the impacts of adding coenzyme Q10 to letrozole on spermiogram and sex hormone in men diagnosed with idiopathic oligo/astheno/ teratozoospermia (iOAT) syndrome.
The study will include 67 patients which will be randomly separated into two groups, Group (A) 29 patients will be treated with letrozole 2.5mg tablet orally twice a week, Group (B) 38 patient will be treated with a combination of letrozole 2.5 mg tablet orally twice a week plus Co-Q10 400mg per day, both groups complete treatment for three months. Semen sample, serum FSH, estradiol (E2), and testosterone (T) were analyzed at day one, and at the end of one, two, and three months.
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult male patients.
- •Aged 18 - 60 years.
- •Confirmed diagnosis with idiopathic Oligo-Astheno-Teratozoospermia (iOAT) syndrome.
排除标准
- •Patients who have been found to have additional infertility causes, such as varicocele or Obstruction of the ejaculatory duct.
- •Those who have had surgery for male factor infertility.
- •Patients with infections such as STD.
- •Patient with renal or liver disease
- •Incomplete patient data
研究组 & 干预措施
Group A
group A (29) patients received letrozole 2.5mg twice weekly for 3 months
干预措施: Letrozole tablets (Drug)
Group B
Group B (38) patients receive letrozole 2.5mg twice a week plus Co Q10 400 mg per day for 3 months
干预措施: Letrozole tablets (Drug)
Group B
Group B (38) patients receive letrozole 2.5mg twice a week plus Co Q10 400 mg per day for 3 months
干预措施: Coenzyme Q10 table (Dietary Supplement)
结局指标
主要结局
The seminal fluid analysis
时间窗: change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment
sperm volume/ ml, Sperm concentration/ml, Total sperm count / ml, Progressive Sperm motility (%), Non-progressive Sperm motility (%), Immotile Sperm (%), Normal Sperm morphology (%)
次要结局
- hormone profile(change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment)
研究者
Mohammed Mahmood Mohammed
Clinical associated professor
Al-Mustansiriyah University