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IRCT2016022821653N5 IRCT 2016-10-25 Vice Chancellor for research of jahrom university of medical sience The influence of vitamin D and vitamin E in the treatment of infertile women with polycystic ovary syndrome Assessing the effect of adding vitamin D and vitamin E to metformin with dydrogesterone regimen؛ in the treatment of infertile women with polycystic ovary syndrome 2016-06-21 anticipated 317 Complete https://irct.ir/trial/18910 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Table of random numbers for choosing patients. 3 Polycystic ovary syndrome. Intervention 1: intervention group 3: metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months.tablet vitamin E 400mg from Dana pharmaceuticals one tablet daily for three months. control group 3: only metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months. Intervention 2: intervention group 2: metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstural cycle to the twenty fifth day of it for three months. capsule vitamin D1000IU from Zahravy pharmaceuticals one capsule daily for three months. control group 2: only metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstural cycle to the twenty fifth day of it for three months. Intervention 3: intervention group 1: metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months. capsule vitamin D1000IU from Zahravy pharmaceuticals one capsule daily for three months. control group 1: only metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months. Intervention 4: intervention group4: metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months.tablet vitamin E 400mg from Dana pharmaceuticals one tablet daily for three months. control group 4: only metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months.
public Dr Kavous Solhjo
Jahrom University of Medical Sience, Motahari boulevard
Jahrom Iran (Islamic Republic of) +98 71 5444 0821 sohjo@jums.ac.ir Jahrom University of Medical Sience scientific Fatemeh Kargarfard
Alley 5. Fard asadi avenue
Jahrom Iran (Islamic Republic of) 7416653134 +7 1330990 fatemehkargarfard@yahoo.com Jahrom University of Medical Sience Iran (Islamic Republic of) Inclusion criteria؛ Infertile women with polycystic ovary syndrome (PCOS)؛ which had no pregnancy history after 12 months of unprotected intercourse. Exclusion criteria؛ Women with other causes of infertility such as endometriosis؛ internal and surgical diseases؛ and patients who do not have polycystic ovary syndrome (PCOS) criteria. no limit no limit Female E28.2 Polycystic ovary syndrome Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs intervention group 3: metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months.tablet vitamin E 400mg from Dana pharmaceuticals one tablet daily for three months. control group 3: only metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months. intervention group 2: metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstural cycle to the twenty fifth day of it for three months. capsule vitamin D1000IU from Zahravy pharmaceuticals one capsule daily for three months. control group 2: only metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstural cycle to the twenty fifth day of it for three months. intervention group 1: metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months. capsule vitamin D1000IU from Zahravy pharmaceuticals one capsule daily for three months. control group 1: only metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months. intervention group4: metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months.tablet vitamin E 400mg from Dana pharmaceuticals one tablet daily for three months. control group 4: only metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months. Follicle size. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Sonography. Endometrial thickness. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Sonography. Menstural discipline. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Sonography. Pregnancy. Timepoint: Before intervention and 3 months after intervention. Method of measurement: BHCG. Weight. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Scale. Vice Chancellor for research of jahrom university of medical sience Approved 2016-02-05 Jahrom University of Medical Sience Jahrom University of Medical Sience. Motahari boulevard Jahrom Iran (Islamic Republic of)