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

NCT03396380 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2018-01-11

No results posted yet for this study

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.

Conditions

  • Ovulation Induction

Interventions

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2018-03-01
Completion
2018-05-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03396380 on ClinicalTrials.gov