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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Ovulation Induction

Intervention / Treatment
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* Drug: Vitamin D with calcium and clomiphene citrate
* Drug: Placebo Oral Tablet with calcium and clomiphene citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vitamin D<br>93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement | Drug: Vitamin D with calcium and clomiphene citrate<br>* 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. 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 .<br>|
| Placebo Comparator: placebo<br>93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement | Drug: Placebo Oral Tablet with calcium and clomiphene citrate<br>* 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. 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate 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 | till cycle day 21 if not reaching more than 18 mm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of growing follicles. | to monitor induction | 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 | in cycle day 14 and 21. | 
| Pregnancy rates | both clinical and biochemical | 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. | for 3 months |