Protocol summary
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Study aim
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Determination of the efficacy of myo-inositol and clomiphene citrate in comparison with metformin and clomiphene citrate on induction of ovulation and pregnancy rates in patients with polycystic ovary syndrome
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Design
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single blind parallel three groups of randomized controlled clinical trial
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Settings and conduct
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Infertility Center, Imam Khomeini Hospital, Mazandaran University of Medical Sciences, Sari, Iran.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Women aged 20-35 year
Suffering from polycystic ovary syndrome
Anovulation and infertility for one year or more
ٍExclusion criteria:Other condition with hyperandrogenism and anovulation (adrenal, hypophysis or ovarian disorders)
Other causes of infertility (male factor or tubal factor)
Use of hormones or drugs that affect ovulation
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Intervention groups
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Intervention 1: Use of Inofolic powder (including myo-inositol 2 gr plus folic acid tab 200 microgram, Shafayab Co from Lolipharma Co), 25 mg twice daily till 12 weeks
Intervention 2: Use of Metformin (tab 500 mg, OSVAH Co, Tehran, Iran), 500 mg three times a day till 12 weeks.
Intervention 3: Use of Clomiphene citrate (tab 50 mg, Iran Hormone Co, Tehran, Iran), 50 mg twice daily from 5 till 9th of menstrual cycle.
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Main outcome variables
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Ovulation rate
General information
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Reason for update
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The wrong date was selected by mistake and needs to be corrected
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160815029374N3
Registration date:
2018-11-28, 1397/09/07
Registration timing:
prospective
Last update:
2025-07-21, 1404/04/30
Update count:
1
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Registration date
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2018-11-28, 1397/09/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-12-01, 1397/09/10
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Expected recruitment end date
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2019-08-01, 1398/05/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison the effects of myo-inositol plus clomiphene citrate with metformin plus clomiphene citrate on induction of ovulation among patients with polycystic ovarian syndrome.
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Public title
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ٍEffects of myo-inositol on induction of ovulation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women aged 20-35 year
Suffering from polycystic ovary syndrome
Anovulation and infertility for one year or more
Exclusion criteria:
Other condition with hyperandrogenism and anovulation (adrenal, hypophysis or ovarian disorders)
Other causes of infertility (male factor or tubal factor)
Use of hormones or drugs that affect ovulation
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Age
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From 20 years old to 35 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
164
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is done based on the Rearrangement of four blocks before the initiation of treatment cycle by one nurse. In fact, only the nurse knows which patient is under the metformin or myo-inositol treatment, or not. Physicians do not know which patient is undergoing intervention, but patients know about the intervention due to informed consent,therefore, it is not possible to concealed the patients in this group.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Reduction of Bias
Enhancing Scientific Validity
Adherence to Ethical Principles
Compliance with International Standards
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-06-27, 1397/04/06
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Ethics committee reference number
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IR.MAZUMS.IMAMHOSPITAL.REC.1397.021
Health conditions studied
1
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Description of health condition studied
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Diseases of the genitourinary system
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ICD-10 code
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N97; N98
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ICD-10 code description
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Female infertility; Complications associated with artificial fertilization
Primary outcomes
1
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Description
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Ovulation rate
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Timepoint
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On day 12 and 14 and 20 of cycle
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Method of measurement
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Questionnare
Secondary outcomes
1
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Description
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Clinical pregnancy rate
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Timepoint
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Forth weeks after positive pregnancy test
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Method of measurement
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Questionnare
Intervention groups
1
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Description
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Intervention group: Use of Inofolic powedr (including myo-inositol 2 gr plus folic acid tab 200 microgram, Shafayab Co from Lolipharma Co), 25 mg twice daily till 12 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: Use of metrformin tablet (Gly-once, 500 mg, Coshan farmed Co), three times a day till 12 weeks.
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Category
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Treatment - Drugs
3
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Description
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Intervention group: Use of Clomiphene citrate tablet (Clomid, 50 mg, Iran Hormone Co), 100 mg daily from 5 till 9 of menstruation.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Science.
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable