NCT03396380

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

January 11, 2018

Status Verified

January 1, 2018

Enrollment Period

8 months

First QC Date

December 16, 2017

Last Update Submit

January 9, 2018

Conditions

Ovulation Induction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Number of growing follicles.

    till cycle day 21 if not reaching more than 18 mm

  • Evaluation of the endometrial thickness

    in cycle day 14 and 21.

  • Pregnancy rates

    pregnancy test 1 week after missed menses

  • Adverse effects

    for 3 months

Study Arms (2)

vitamin D

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

Vitamin D with calcium and clomiphene citrateDRUG

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 .

vitamin D
Placebo Oral Tablet with calcium and clomiphene citrateDRUG

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

placebo

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams university maternity hospital

Cairo, Abbassya, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32363556DERIVED

MeSH Terms

Interventions

Vitamin DCalciumClomiphene

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Radwa R Ali

CONTACT

01283492979radwaebed@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

December 16, 2017

First Posted

January 11, 2018

Study Start

July 1, 2017

Primary Completion

March 1, 2018

Study Completion

May 1, 2018

Last Updated

January 11, 2018

Record last verified: 2018-01

Locations

EG(1)