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临床试验/NCT04916925
NCT04916925Unknown1 期

Effect of Vitamin D Oral Supplementation in Poly Cystic Ovarian Women Resistant to Clomiphene Citrate

rana alaaeldin aly ibrahim nasr0 个研究点目标入组 100 人开始时间: 2021年8月21日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

发起方
rana alaaeldin aly ibrahim nasr
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

rana alaaeldin aly ibrahim nasr

Clinical gynecology professor

Ain Shams University

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