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

Primary Purpose

Ovulation Induction

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D with calcium and clomiphene citrate
Placebo Oral Tablet with calcium and clomiphene citrate
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovulation Induction

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • AinShams university maternity hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

vitamin D

placebo

Arm Description

93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement

93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of growing follicles.
to monitor induction
Evaluation of the endometrial thickness
could be impaired with antiestrogenic effect of clomiphen citrate
Pregnancy rates
both clinical and biochemical
Adverse effects
hot flashes, headache, nausea, vomiting, breast tenderness, blurred vision, abdominal distention and pain and ovarian enlargement or hyperstimulation.

Full Information

First Posted
December 16, 2017
Last Updated
January 9, 2018
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03396380
Brief Title
Effect of Vitamin D Supplement in Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome
Official Title
Effect of Adding Vitamin D Supplement to Clomiphene Citrate for Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Anticipated)
Study Completion Date
May 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovulation Induction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vitamin D
Arm Type
Active Comparator
Arm Description
93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement
Intervention Type
Drug
Intervention Name(s)
Vitamin D with calcium and clomiphene citrate
Intervention Description
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 .
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet with calcium and clomiphene citrate
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of ovulation
Description
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
Time Frame
till cycle day 21 if not reaching more than 18 mm
Secondary Outcome Measure Information:
Title
Number of growing follicles.
Description
to monitor induction
Time Frame
till cycle day 21 if not reaching more than 18 mm
Title
Evaluation of the endometrial thickness
Description
could be impaired with antiestrogenic effect of clomiphen citrate
Time Frame
in cycle day 14 and 21.
Title
Pregnancy rates
Description
both clinical and biochemical
Time Frame
pregnancy test 1 week after missed menses
Title
Adverse effects
Description
hot flashes, headache, nausea, vomiting, breast tenderness, blurred vision, abdominal distention and pain and ovarian enlargement or hyperstimulation.
Time Frame
for 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Radwa R Ali
Phone
01283492979
Ext
02002
Email
radwaebed@yahoo.com
Facility Information:
Facility Name
AinShams university maternity hospital
City
Cairo
State/Province
Abbassya
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radwa R Ali, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32363556
Citation
Rasheedy R, Sammour H, Elkholy A, Salim Y. The efficacy of vitamin D combined with clomiphene citrate in ovulation induction in overweight women with polycystic ovary syndrome: a double blind, randomized clinical trial. Endocrine. 2020 Aug;69(2):393-401. doi: 10.1007/s12020-020-02315-3. Epub 2020 May 3.
Results Reference
derived

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

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