Evaluation of the Effect of Pentoxifylline and α-Lipoic Acid as Adjunctive 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
- 120
- 试验地点
- 3
- 主要终点
- ovulation rate measure the number of patients who ovulate per cycle
研究概览
简要总结
This study evaluate the addition of PTX and ALA to clomiphene citrate in the treatment of polycystic ovary.
详细描述
Clomiphene, PTX and ALA 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.
PTX and ALA are 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.
- •Patients who have previously received clomiphene citrate (CC) and being diagnosed as having CC resistance
- •Body mass index (18-30) kg/m2.
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
- •Patients who are hypersensitive to pentoxifylline or other xanthines such as caffeine, theophylline and theobromine or to any ingredient in the formulation or component of the container.
- •Patients with acute myocardial infraction, severe coronary artery disease.
- •Patients with hemorrhage or at risk of increased bleeding and Patients with peptic ulcers.
研究组 & 干预措施
Pentoxifylline (PTX) group
30 patients
干预措施: Pentoxifylline (PTX) (Drug)
Pentoxifylline (PTX) group
30 patients
干预措施: Clomiphene Citrate (Drug)
Alpha lipoic acid (ALA) group
30 patients
干预措施: Alpha lipoic acid (ALA) (Dietary Supplement)
Alpha lipoic acid (ALA) group
30 patients
干预措施: Clomiphene Citrate (Drug)
Combined PTX and ALA group
30 patients
干预措施: Alpha lipoic acid (ALA) (Dietary Supplement)
Combined PTX and ALA group
30 patients
干预措施: Pentoxifylline (PTX) (Drug)
Combined PTX and ALA group
30 patients
干预措施: Clomiphene Citrate (Drug)
control group
clomiphene
干预措施: Clomiphene Citrate (Drug)
结局指标
主要结局
ovulation rate measure the number of patients who ovulate per cycle
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
principal investigator
Ain Shams University