Effect of Vitamin D Oral Supplementation in Poly Cystic Ovarian Women Resistant to Clomiphene Citrate
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 主要终点
- number of the ovulated follicles
研究概览
简要总结
effect of vitamin D oral supplementation in poly csytic ovarian women resistant to clomiphene citrate
详细描述
Polycystic ovarian syndrome is the most common endocrine disorder . It is associated with chronic anovulation and infertility. The diagnosis is made by clinical and ancillary investigations revealing the presence of irregular menstrual cycles, an ovulation , Hyperandrgenemia , and the presence of polycystic ovaries (ovarian morphology as the presence of 12 or more follicles measuring 2-9 mm in diameter and an increased ovarian volume >10 cm 3) ovulation can be induced with clomiphene citrate (CC), However, ~20%-25% of anovulatory women with PCOS do not respond to CC and are considered to be "clomiphene-resistant( clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days ) Vitamin D may serve as a key in preventing and attenuating the insulin resistance. Vitamin D plays a physiologic role in reproduction including ovarian follicular development and luteinisation, follicle-stimulating hormone sensitivity and progesterone production in human granulosa cells. It also affects glucose homeostasis .
In this trial 100 women with PCO disease that diagnosed by ROTTERDAM CRITERIA (must have any TWO of This findings: Hyperandrogenism, Oligomenorrhea, Polycystic ovaries). Who are taking clomiphene citrate for induction of ovulation and resistant to it, which means failure to ovulate with 3 months of usage of clomid at 150 mg/day for 5 days. They will recieve vitamin D (ossofortin®, Eva Pharma) orally 10000 IU twice weekly for other three months period with clomiphene citrate orally 150 mg/day for 5 days. Number and size of the growing follicles will be monitored before and after taking vitamin D by trans-vaginal ultrasound at day11-14 of the cycle till day 21 to detect effect of vitamin D in ovulation rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18-40 years 2- Polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria.
- •Polycystic ovaries (either 12 or more follicles or increased ovarian volume [> 10 cm3
- •Oligo-ovulation or anovulation
- •Clinical and/or biochemical signs of hyperandrogenism (Azziz, 2006). 3- PCOS infertile women resistant to CC for 3 cycles. clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days
排除标准
- •Causes of infertility other than PCOS.
- •Male factor.(normal semen analysis)
- •Other factors e.g. endometriosis
- •Tubal factor. (normal hysterosalpingography)
- •Premature ovarian failure: Day 3 FSH > 14 mlu/ml or antimullerian hormone <1 ng/ml.
- •Normal ultrasound except for criteria of PCO
- •Causes of anovulation other than PCOS.
- •Patients with hyperprolactinemia
- •Patients with thyroid dysfunction.
- •Current or in last six months use of vit D treatment.
研究组 & 干预措施
pcos resistant to cc plus vit d
100 patients who are PCOS and resist CC will receive Vitamin D 10000 IU orally plus 150mg clomid orally for 3 months number and size of growing follicles will be monitored
干预措施: Vitamin D (Drug)
pcos resistant to cc plus vit d
100 patients who are PCOS and resist CC will receive Vitamin D 10000 IU orally plus 150mg clomid orally for 3 months number and size of growing follicles will be monitored
干预措施: Clomid (Drug)
结局指标
主要结局
number of the ovulated follicles
时间窗: 36 hours of taking HCG injection
Number of ovulated follicles by trans vaginal ultra sound signs of ovulation
次要结局
- pregancy rate(2 days after delayed menses)
- Evaluation of the endometrial thickness(36 hour of taking HCG)
研究者
rana alaaeldin aly ibrahim nasr
Clinical gynecology professor
Ain Shams University
