NCT03396380

Effect of Vitamin D Supplement in Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome

Effect of Adding Vitamin D Supplement to Clomiphene Citrate for Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 25 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The aim of this work is to evaluate the effect of vitamin D supplementation in overweight infertile women with PCOs undergoing induction of ovulation.

Detailed description

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

Conditions

• Ovulation Induction

Interventions

Type	Name	Description
DRUG	Vitamin D with calcium and clomiphene citrate	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 .
DRUG	Placebo Oral Tablet with calcium and clomiphene citrate	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

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-03-01
• Completion: 2018-05-01
• First posted: 2018-01-11
• Last updated: 2018-01-11

Locations

1 site across 1 country: Egypt