The Clinical and Biochemical Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome (PCOS)
试验速览
- 阶段
- 1 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Ovulatory pattern improvements
研究概览
简要总结
An open clinical trial
详细描述
The patients with PCOS will be recruited to receive folic acid (45 patients) and equal number will receive no folic acid
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who will visit this centre suffering from PCOS-related subfertility will be invited to be enrolled to this study if met the Rotterdam criteria for the diagnosis of PCOS
排除标准
- •The patients whom will be excluded from the study are those comorbid with hyperprolactinemia, congenital adrenal hyperplasia, diabetes mellitus, significant cardiovascular problems, thyroid dysfunctions, unresolved medical conditions, or using medications suspected to affect reproductive or metabolic functions within two months of the study entry.
研究组 & 干预措施
Treatment group
45 PCOS patients will receive 5 mg folic acid
干预措施: Folic Acid (Drug)
结局指标
主要结局
Ovulatory pattern improvements
时间窗: 3 months
Ovulatory pattern will be assessed based on the history of the PCOS patients, the patients whom were having baseline oligomenorrhea or amenorrhea will be re-assessed for resuming regular cycles defined as periods lasting 22 - 35 days. this pattern improvement will be compared in the treatment group and control group using questionnaire
Clinical signs of hyperandrogenemia
时间窗: 3 months
Hirsutism will be used as a sign of hyperandrogenemia, Patients will be provided with modified Ferriman -Gallwey (mFG) images to self-rate hair growth in each of the 9 body areas (upper lip, chin, chest, upper and lower back, upper and lower abdomen, thighs, and upper arms). For each site, a score on a scale of 0 to 4 was recorded. A total score of 8 or greater is defined as clinical evidence of hirsutism; scores from 8 to 15 are considered mild hirsutism; scores from16 to 25 are considered moderate; and scores from 26 to 36 are considered severe hirsutism. The baseline and after 3 months hirsutism compared in the treatment group and control group
pregnancy rates
时间窗: 3 months
Pregnancy rates will be compared in the treatment group and control group
次要结局
- Plasma level of insulin(3 months)
- Plasma level of testosterone(3 months)
- Plasma level of follicle-stimulating hormone (FSH)(3 months)
- Plasma level of luteinizing hormone (LH)(3 months)
研究者
Mohammed Hassan Alnazeer
Clinical Pharmacist
University of Khartoum