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IRCT20160815029374N3 IRCT 2018-11-28 Mazandaran University of Medical Science. ٍEffects of myo-inositol on induction of ovulation Comparison the effects of myo-inositol plus clomiphene citrate with metformin plus clomiphene citrate on induction of ovulation among patients with polycystic ovarian syndrome. 2018-12-01 anticipated 164 Complete https://irct.ir/trial/31123 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 description: Reduction of Bias Enhancing Scientific Validity Adherence to Ethical Principles Compliance with International Standards. 3 Diseases of the genitourinary system. Intervention 1: 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. Intervention 2: Control group: Use of metrformin tablet (Gly-once, 500 mg, Coshan farmed Co), three times a day till 12 weeks. Intervention 3: Intervention group: Use of Clomiphene citrate tablet (Clomid, 50 mg, Iran Hormone Co), 100 mg daily from 5 till 9 of menstruation. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Marzieh Zamaniyan
233 plaque, Ground Floor, IVF ward, Imam Khomeini Hospital, Amir Mazandarani Ave, Sari.
Sari Iran (Islamic Republic of) 139944176 +98 11 3336 5724 m.zamanian@mazums.ac.ir Infertility Center, Department of Obstetrics and Gynecology, Mazandaran University of Medical Scienc scientific Marzieh Zamaniyan
233 plaque, Ground Floor, IVF ward, Imam Khomeini Hospital, Amir Mazandarani Ave, Sari.
Sari Iran (Islamic Republic of) 13934313 +98 11 3336 5724 marziehzamaniyan@gmai.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women aged 20-35 year Suffering from polycystic ovary syndrome Anovulation and infertility for one year or more 20 years 35 years Female 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 N97; N98 Female infertility; Complications associated with artificial fertilization Treatment - Drugs Treatment - Drugs Treatment - Drugs 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. Control group: Use of metrformin tablet (Gly-once, 500 mg, Coshan farmed Co), three times a day till 12 weeks. Intervention group: Use of Clomiphene citrate tablet (Clomid, 50 mg, Iran Hormone Co), 100 mg daily from 5 till 9 of menstruation. Ovulation rate. Timepoint: On day 12 and 14 and 20 of cycle. Method of measurement: Questionnare. Clinical pregnancy rate. Timepoint: Forth weeks after positive pregnancy test. Method of measurement: Questionnare. Mazandaran University of Medical Science. Approved 2018-06-27 Ethics committee of Mazandaran University of Medical Science. 240 Plaque, Third floor, Mazandaran University of Medical Sciences, Joybar street, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)