Evaluation of the Clinical Outcome of Vitamin E as Adjuvant Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ovulation rate
研究概览
简要总结
This study evaluate the addition of Vit E to clomiphene citrate in the treatment of poly cystic ovary.Half the patients will receive both Vit E and clomiphene citrate the other half will receive clomiphene citrate only.
详细描述
Clomiphene and vit E each used in treatment of pco but they do so by different mechanisms.
Clomifene is in the selective estrogen receptor modulator (SERM) family of medication. It works by causing the release of gonadotropin-releasing hormone by the hypothalamus, and subsequently gonadotropin from the anterior pituitary.
Vit E is used in treatment of pco due its anti-oxidant effect.
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients will be diagnosed as having PCOS according to the Rotterdam criteria for diagnosis of PCOS
- •Age between 18 and 39 years.
- •Period of infertility >1 years.
- •No treatment taken during the last 2 months.
- •Patients who have previously received clomiphene citrate (CC) and being diagnosed as having CC resistance
排除标准
- •History of pelvic surgery or infertility factor other than anovulation
- •Endocrine disorders in the form of hypothyroidism or hyperthyroidism, hyperprolactinemia, and Cushing syndrome, as detected by history, examination, or investigations.
- •Known cases of endometriosis (approved histologically), uterine anomaly or hydrosalpinx, retinitis pigmentosa and vitamin K deficiency.
- •Consumption of vitamin and antioxidant supplementations in the last three-months before the trial start date.
- •Male factor infertility (sperm count < 5 million per milliliter, normal morphology <4%).
- •Elevated serum prolactin, T.S.H and F.S.H.
- •Patients diagnosed with diabetes mellitus
研究组 & 干预措施
vitamin E group
30 patient
干预措施: Clomiphene Citrate (Drug)
vitamin E group
30 patient
干预措施: vitamin E (Dietary Supplement)
vitamin E group
30 patient
干预措施: Metformin (Drug)
control group
clomiphene
干预措施: Metformin (Drug)
control group
clomiphene
干预措施: Clomiphene Citrate (Drug)
结局指标
主要结局
ovulation rate
时间窗: 3 months
Follicles measure more than 18 mm will be considered mature follicles.
次要结局
未报告次要终点
研究者
Ahmed Abbas Morsy Morsy
pharmacist
Ain Shams University