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IRCT20190825044605N1 IRCT 2019-09-27 Sanandaj University of Medical Sciences The effect of Inofolic Supplement on infertility treatment in women with polycystic ovarian syndrome Evaluating the effect of combination of Inofolic Supplement and Klomifen and Klomifen alone on infertility treatment in women with polycystic ovarian syndrome 2019-04-21 anticipated 80 Complete https://irct.ir/trial/41717 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be selected by simple random sampling method. Patients will be selected by researcher visiting the infertility clinic daily. After giving the necessary explanation about the study and signing the informed consent form, researcher will give a card to patients from a package containing 80 closed envelopes which contains cards A (intervention group) and B (control group). Patients will be divided into groups A (intervention group) and B (control group) based on the card they received. Sampling continues in two parallel groups until the number of samples completed. Patients have no information about grouping, Blinding description: Both intervention and control groups receive routine infertility treatment but they both are unaware of the group they are assigned and they will be kept blind about the drug type they will receive. N/A Polycystic ovarian syndrome. Intervention 1: Intervention group: Patients in the intervention group will be given clomiphene and inofolic supplement for 3 months. In the first month of the intervention, 50 mg clomiphene is administered to the patient for 5 days from the third day of menstruation, an inofolic sachets containing 2000 g myoinositol and 200 μg folic acid is administered daily until the end of the month. In the second month of the intervention, 100 mg clomiphene is administered to the patient for 5 days from the third day of menstruation, an inofolic sachets containing 2000 g myoinositol and 200 μg folic acid is administered daily until the end of the month.In the third month of the intervention, 150 mg clomiphene is administered to the patient for 5 days from the third day of menstruation, an inofolic sachets containing 2000 g myoinositol and 200 μg folic acid is administered daily until the end of the month. Intervention 2: Control group: Patients in the control group received only clomiphene for 3 months. In the first month 50 mg clomiphene is administered to the patient for 5 days from the third day of menstruation. In the second month 100 mg clomiphene is administered to the patient for 5 days from the third day of menstruation.In the third month 150 mg clomiphene is administered to the patient for 5 days from the third day of menstruation. Yes - There is a plan to make this available What will be shared: Some part of the data on the primary outcome can be shared. When: One year after the publication of the paper the data will be available. To whom: Researchers working in academic and scientific institutions. Conditions: Meta-analysis is allowed on the data of this study. Where to obtain: Dr. Khadijeh Ebrahimpouri, Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran,Email: k.ebrahimpour@muk.ac.ir How to obtain: After one year of publishing the article and publishing the results, those who need the data of this study, could apply via email . Comments:
public Khadijeh Ebrahimpour
Kurdistan University of Medical Sciences, Pasdaran street
Sanandaj Iran (Islamic Republic of) 66177-13446 +98 87 3366 4673 k.ebeahimpour@muk.ac.ir Sanandaj University of Medical Sciences scientific Nasrin Soofizadeh
Besat Hospital, Keshavarz street
Sanandaj Iran (Islamic Republic of) 66177-13446 +98 87 3328 5910 nsoofizadeh@hotmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Age range of 20 to 40 years old Infertile women with polycystic ovarian syndrome 20 years 40 years Female Ovarian surgery history in the past three months Use of antiepileptic drugs and glucocorticoids Congenital adrenal hyperplasia Hypothyroidism Hyperthyroidism E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: Patients in the intervention group will be given clomiphene and inofolic supplement for 3 months. In the first month of the intervention, 50 mg clomiphene is administered to the patient for 5 days from the third day of menstruation, an inofolic sachets containing 2000 g myoinositol and 200 μg folic acid is administered daily until the end of the month. In the second month of the intervention, 100 mg clomiphene is administered to the patient for 5 days from the third day of menstruation, an inofolic sachets containing 2000 g myoinositol and 200 μg folic acid is administered daily until the end of the month.In the third month of the intervention, 150 mg clomiphene is administered to the patient for 5 days from the third day of menstruation, an inofolic sachets containing 2000 g myoinositol and 200 μg folic acid is administered daily until the end of the month. Control group: Patients in the control group received only clomiphene for 3 months. In the first month 50 mg clomiphene is administered to the patient for 5 days from the third day of menstruation. In the second month 100 mg clomiphene is administered to the patient for 5 days from the third day of menstruation.In the third month 150 mg clomiphene is administered to the patient for 5 days from the third day of menstruation. The number of developed follicles. Timepoint: Two weeks after the intervention. Method of measurement: Using Sonography. The number of clinical pregnancies. Timepoint: Third week after intervention. Method of measurement: Based on Beta-HCG and ultrasound confirmation. Sanandaj University of Medical Sciences Approved 2019-01-02 Ethics committee of Kurdistan University of Medical Sciences Kurdistan University of Medical Sciences, Pasdaran street Sanandaj Kurdistan Iran (Islamic Republic of)