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

Phase 3

• Conditions: Ovulation Induction
• Interventions: Drug: Placebo Oral Tablet with calcium and clomiphene citrate; Drug: Vitamin D with calcium and clomiphene citrate

• Registration Number: NCT03396380
• Lead Sponsor: Ain Shams University

Brief 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-12-16
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-09
• Last Update Submitted: 2018-01-09
• Study First Posted: 2018-01-11
• Last Update Posted: 2018-01-11
• Primary Completion: 2018-03-01
• Study Completion: 2018-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 186

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo Oral Tablet with calcium and clomiphene citrate	93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement
vitamin D	Vitamin D with calcium and clomiphene citrate	93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement

Primary Outcome Measures

Name	Time	Method
Rate of ovulation	till cycle day 21 if not reaching more than 18 mm	* 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

Secondary Outcome Measures

Name	Time	Method
Evaluation of the endometrial thickness	in cycle day 14 and 21.	could be impaired with antiestrogenic effect of clomiphen citrate
Adverse effects	for 3 months	hot flashes, headache, nausea, vomiting, breast tenderness, blurred vision, abdominal distention and pain and ovarian enlargement or hyperstimulation.
Number of growing follicles.	till cycle day 21 if not reaching more than 18 mm	to monitor induction
Pregnancy rates	pregnancy test 1 week after missed menses	both clinical and biochemical

Trial Locations

Locations (1)

AinShams university maternity hospital; 🇪🇬 Cairo, Abbassya, Egypt