Correction of Vitamin D Deficiency and Its Effect on Ovulation Induction in Women With PCOS (VIDEO): A Feasibility RCT
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- cumulative clomiphene citrate-induced ovulation rates
研究概览
简要总结
Recently, a special emphasis has recently been directed to the potential role of vitamin D and some regulatory peptides (e.g. adipokines and follistatin) and their associated metabolic roles and genetic factors in the development of PCOS and its related co-morbidities. The aim of this study was to assess the feasibility of conducting a pragmatic RCT assessing the effectiveness of adopting a protocol of screening for and correcting Vitamin D deficiency in women with PCOS seeking fertility treatment in a low/middle income care (LMIC) setting
详细描述
Research question:
In PCOS patients, is there any effect of vitamin D testing and correction on ovulation induction in women with PCOS?
Research hypothesis:
There is effect of testing and correcting vitamin D status as regard ovulation in patients with PCOS
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria
排除标准
- •1- PCOS patients not in child bearing age; less than 18 years or more than 45 years.
- •2- Patients with congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia and virilizing ovarian or adrenal tumors.
- •3- PCOS patients with any other medical illness. 4- PCOS patients already on vitamin D supplements.
研究组 & 干预措施
Vitamin D
1st subgroup will be tested and treated with vitamin D together with Clomiphene Citrate for induction of ovulation
干预措施: Vitamin D (Drug)
Vitamin D
1st subgroup will be tested and treated with vitamin D together with Clomiphene Citrate for induction of ovulation
干预措施: Ovulatory Agent (Drug)
control
2nd subgroup will be treated with Clomophene Citrate only
干预措施: Ovulatory Agent (Drug)
结局指标
主要结局
cumulative clomiphene citrate-induced ovulation rates
时间窗: 6 months
Ultrasound Folliculometry was performed every other day starting on the 10th day of the induction cycle. Until, at least, one follicle reached 18mm in diameter
次要结局
- median ovulating dose of clomiphene citrate(6 months)
- Cumlative clinical pregnancy rate(6 months)
研究者
Ahmed Mohamed El Kotb Abdel Fattah
Dr. Ahmed Kotb
Ain Shams University