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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Protocol summary
not blind parallel three groups of randomized controlled clinical trial
single blind parallel three groups of randomized controlled clinical trial
notsingle blind parallel three groups of randomized controlled clinical trial
کارآزمایی بالینی دارای سه گروه کنترل، با دو گروه موازی ، کور نشده ، تصادفی شده
کارآزمایی بالینی دارای سه گروه کنترل، با دو گروه موازی ، تک سو کور ، تصادفی شده
کارآزمایی بالینی دارای سه گروه کنترل، با دو گروه موازی ، تک سو کور نشده ، تصادفی شده
General information
Not blinded
Single blinded
notblsingl
1
1
2018-06-22, 1397/04/01
2018-12-01, 1397/09/10
2018-0612-2201 00:00:00
2019-02-20, 1397/12/01
2019-08-01, 1398/05/10
2019-0208-2001 00:00:00
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The wrong date was selected by mistake and needs to be corrected
The wrong date was selected by mistake and needs to be corrected
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به اشتباه تاریخ نادرستی انتخاب شده و نیاز به اصلاح دارد.
به اشتباه تاریخ نادرستی انتخاب شده و نیاز به اصلاح دارد.
Reduction of Bias
Enhancing Scientific Validity
Adherence to Ethical Principles
Compliance with International Standards
Reduction of Bias Enhancing Scientific Validity Adherence to Ethical Principles Compliance with International Standards
کاهش سوگرایی
افزایش اعتبار علمی
رعایت اصول اخلاقی
همخوانی با استانداردهای بینالمللی
کاهش سوگرایی افزایش اعتبار علمی رعایت اصول اخلاقی همخوانی با استانداردهای بینالمللی
Ethics committees
#1
2018-11-13, 1397/08/22
2018-06-27, 1397/04/06
2018-1106-1327 00:00:00
Protocol summary
Study aim
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
Design
single blind parallel three groups of randomized controlled clinical trial
Settings and conduct
Infertility Center, Imam Khomeini Hospital, Mazandaran University of Medical Sciences, Sari, Iran.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Ovulation rate
General information
Reason for update
The wrong date was selected by mistake and needs to be corrected
Acronym
IRCT registration information
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
Registration date
2018-11-28, 1397/09/07
Registrant information
Name
Marzieh Zamaniyan
Name of organization / entity
Mazandaran University of Medical Sciences, Sari, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 5724
Email address
m.zamanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-01, 1397/09/10
Expected recruitment end date
2019-08-01, 1398/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of myo-inositol plus clomiphene citrate with metformin plus clomiphene citrate on induction of ovulation among patients with polycystic ovarian syndrome.
Public title
ٍEffects of myo-inositol on induction of ovulation
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
164
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
Reduction of Bias
Enhancing Scientific Validity
Adherence to Ethical Principles
Compliance with International Standards
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Science.
Street address
240 Plaque, Third floor, Mazandaran University of Medical Sciences, Joybar street, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815659769
Approval date
2018-06-27, 1397/04/06
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.021
Health conditions studied
1
Description of health condition studied
Diseases of the genitourinary system
ICD-10 code
N97; N98
ICD-10 code description
Female infertility; Complications associated with artificial fertilization
Primary outcomes
1
Description
Ovulation rate
Timepoint
On day 12 and 14 and 20 of cycle
Method of measurement
Questionnare
Secondary outcomes
1
Description
Clinical pregnancy rate
Timepoint
Forth weeks after positive pregnancy test
Method of measurement
Questionnare
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: Use of metrformin tablet (Gly-once, 500 mg, Coshan farmed Co), three times a day till 12 weeks.
Category
Treatment - Drugs
3
Description
Intervention group: Use of Clomiphene citrate tablet (Clomid, 50 mg, Iran Hormone Co), 100 mg daily from 5 till 9 of menstruation.