Effect of Adding Vitamin D Supplement to Clomiphene Citrate for Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 3 期
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Rate of ovulation
研究概览
简要总结
The aim of this work is to evaluate the effect of vitamin D supplementation in overweight infertile women with PCOs undergoing induction of ovulation.
详细描述
The study will include overweight infertile women with PCOS seeking fertility who will receive induction of ovulation by clomiphene citrate will be recruited and randomized into two groups:
Group A (study group): 93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement
Group B (control group): 93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria.
- •infertility is the cause for seeking treatment.
- •overweight females with BMI more than 25 but less than 30.
排除标准
- •causes of infertility other than PCOS.
- •causes of anovulation other than PCOS.
- •current or in last six months use of hormonal treatment.
- •contraindication to any drug used in the study.
研究组 & 干预措施
vitamin D
93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement
干预措施: Vitamin D with calcium and clomiphene citrate (Drug)
placebo
93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement
干预措施: Placebo Oral Tablet with calcium and clomiphene citrate (Drug)
结局指标
主要结局
Rate of ovulation
时间窗: till cycle day 21 if not reaching more than 18 mm
* Transvaginal ultrasound will be done to detect signs of ovulation: corpus luteum, fluid in cul-de-sac, collapse of the follicle size. * Serum progesterone will be measured in the mid luteal day of the cycle, where: Level 19 nmol/L indicates Ovulation. Level \<5 nmol/L suggests Ovulation did not occur
次要结局
- Evaluation of the endometrial thickness(in cycle day 14 and 21.)
- Adverse effects(for 3 months)
- Number of growing follicles.(till cycle day 21 if not reaching more than 18 mm)
- Pregnancy rates(pregnancy test 1 week after missed menses)
研究者
Radwa Rasheedy Ali
lecturer
Ain Shams University