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

January 9, 2018 updated by: Radwa Rasheedy Ali, Ain Shams University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

186

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbassya
      • Cairo, Abbassya, Egypt
        • Recruiting
        • Ainshams University maternity hospital
        • Contact:
          • Radwa R Ali, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: vitamin D
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
  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 .
Placebo Comparator: placebo
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
  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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of ovulation
Time Frame: 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
till cycle day 21 if not reaching more than 18 mm

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

December 16, 2017

First Submitted That Met QC Criteria

January 9, 2018

First Posted (Actual)

January 11, 2018

Study Record Updates

Last Update Posted (Actual)

January 11, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ain shams maternity hospital (Other Grant/Funding Number: Ain shams maternity hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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