The aim of this work is to evaluate the effect of vitamin D supplementation in overweight infertile women with PCOs undergoing induction of ovulation.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
186
1. Vitamin D ( ossofortin®, EVA PHARMA) 10000 IU twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries ) 1250 mg twice daily which provide elemental calcium 500 mg/tablet for one month before induction of ovulation and both will be continued during the 3 induction cycles in the same regimen. 2. Induction of ovulation by clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily 12 hours apart (total dose 100 mg daily) starting from the third day of menstrual cycle and for five days .
1. The placebo tablet twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries ) 1250 mg twice daily which provide elemental calcium 500 mg/tablet for one month before induction of ovulation and both will be continued during the 3 induction cycles in the same regimen. 2. induction of ovulation by clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily 12 hours apart (total dose 100 mg daily)starting from the 3rd day of menstrual cycle and for five days
AinShams university maternity hospital
Cairo, Abbassya, Egypt
RECRUITINGRate of ovulation
* 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
Time frame: till cycle day 21 if not reaching more than 18 mm
Number of growing follicles.
to monitor induction
Time frame: till cycle day 21 if not reaching more than 18 mm
Evaluation of the endometrial thickness
could be impaired with antiestrogenic effect of clomiphen citrate
Time frame: in cycle day 14 and 21.
Pregnancy rates
both clinical and biochemical
Time frame: pregnancy test 1 week after missed menses
Adverse effects
hot flashes, headache, nausea, vomiting, breast tenderness, blurred vision, abdominal distention and pain and ovarian enlargement or hyperstimulation.
Time frame: for 3 months
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