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IRCT201206072967N4 IRCT 2012-10-07 Vice chancellor of research, Kashan University of Medical Sciences Vaginal Progesterone effect on pregnancy rate in infertility women with polycystic ovarian syndrome Evaluation of efficacy of vaginal progesterone on pregnancy rate in women with polycystic ovarian syndrome using combination therapies for ovulation induction 2012-07-22 anticipated 200 Complete https://irct.ir/trial/2887 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, randomization is done based on randomized numbers. 2 Infertility and Polycystic Ovarian Syndrome. Intervention 1: Intervention group 1: letrozole (Femara; Novartis Pharma AG, Switzerland) 5 mg daily during 3-7 days of menstruation and then, 150 IU gonadotropin (Merional, IBSA, Switzerland) daily will be given from 5-9 days of cycle. After day 10 of the menstrual cycle , If there are at least one dominant follicle with 18-20 mm and endometrial thickness is 6-8 mm in sonography, 5000 IU of HCG ampoule (Choriomon, IBSA, Switzerland), intramuscular will be injected. Then, vaginal progesterone suppository (Cyclogest, serano, Istanbul, Turkey) 400 mg daily.will be given for two weeks. Intervention 2: Intervention group 2: clomiphene (100 mg, daily) during 3-7 days of menstruation and then, 150 IU gonadotropin (Merional, IBSA, Switzerland) daily will be given from 5-9 days of cycle. After day 10 of the menstrual cycle , If there are at least one dominant follicle with 18-20 mm and endometrial thickness is 6-8 mm in sonography, 5000 IU of HCG ampoule (Choriomon, IBSA, Switzerland), intramuscular will be injected. Then, vaginal progesterone suppository (Cyclogest, serano, Istanbul, Turkey) 400 mg daily.will be given for two weeks. Intervention 3: Control group 1: letrozole (Femara; Novartis Pharma AG, Switzerland) 5 mg daily during 3-7 days of menstruation and then, 150 IU gonadotropin (Merional, IBSA, Switzerland) daily will be given from 5-9 days of cycle. After day 10 of the menstrual cycle , If there are at least one dominant follicle with 18-20 mm and endometrial thickness is 6-8 mm in sonography, 5000 IU of HCG ampoule (Choriomon, IBSA, Switzerland), intramuscular will be injected. Intervention 4: Control group 2: clomiphene (100 mg, daily) during 3-7 days of menstruation and then, 150 IU gonadotropin (Merional, IBSA, Switzerland) daily will be given from 5-9 days of cycle. After day 10 of the menstrual cycle , If there are at least one dominant follicle with 18-20 mm and endometrial thickness is 6-8 mm in sonography, 5000 IU of HCG ampoule (Choriomon, IBSA, Switzerland), intramuscular will be injected.
public Dr. Fatemeh Foroozanfard
Shahid Beheshti Hospital, Parastar Blvd, Ghotbe Ravandi Blvd
Kashan Iran (Islamic Republic of) +98 36 1542 1355 fatemehforoozanfard@yahoo.comØ› forozanfar_f@kaums.ac.ir Kashan University of Medical Sciences scientific Dr. Fatemeh Foroozanfard
Shahid Beheshti Hospital, Parastar Blvd, Ghotbe Ravandi Blvd
Kashan Iran (Islamic Republic of) +98 36 1542 1355 fatemehforoozanfard@yahoo.comØ› forozanfar_f@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria consist 20 -35 years, having Rotterdam criteria (having 2 from 3 following criteria: Oligomenorrehea or amenorrhea, polycystic ovaries in sonography, clinical or biochemical evidences of hyperandrogenism). The patient with abnormal hormonal assay in the third day of menstruation (including FSH, TSH, prolactin, 17 Hydroxy progesterone and testosterone), tubal obstruction in HSG or laparoscopy and infertility due to male factor will be excluded. 20 years 35 years Female E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: letrozole (Femara; Novartis Pharma AG, Switzerland) 5 mg daily during 3-7 days of menstruation and then, 150 IU gonadotropin (Merional, IBSA, Switzerland) daily will be given from 5-9 days of cycle. After day 10 of the menstrual cycle , If there are at least one dominant follicle with 18-20 mm and endometrial thickness is 6-8 mm in sonography, 5000 IU of HCG ampoule (Choriomon, IBSA, Switzerland), intramuscular will be injected. Then, vaginal progesterone suppository (Cyclogest, serano, Istanbul, Turkey) 400 mg daily.will be given for two weeks. Intervention group 2: clomiphene (100 mg, daily) during 3-7 days of menstruation and then, 150 IU gonadotropin (Merional, IBSA, Switzerland) daily will be given from 5-9 days of cycle. After day 10 of the menstrual cycle , If there are at least one dominant follicle with 18-20 mm and endometrial thickness is 6-8 mm in sonography, 5000 IU of HCG ampoule (Choriomon, IBSA, Switzerland), intramuscular will be injected. Then, vaginal progesterone suppository (Cyclogest, serano, Istanbul, Turkey) 400 mg daily.will be given for two weeks. Control group 1: letrozole (Femara; Novartis Pharma AG, Switzerland) 5 mg daily during 3-7 days of menstruation and then, 150 IU gonadotropin (Merional, IBSA, Switzerland) daily will be given from 5-9 days of cycle. After day 10 of the menstrual cycle , If there are at least one dominant follicle with 18-20 mm and endometrial thickness is 6-8 mm in sonography, 5000 IU of HCG ampoule (Choriomon, IBSA, Switzerland), intramuscular will be injected. Control group 2: clomiphene (100 mg, daily) during 3-7 days of menstruation and then, 150 IU gonadotropin (Merional, IBSA, Switzerland) daily will be given from 5-9 days of cycle. After day 10 of the menstrual cycle , If there are at least one dominant follicle with 18-20 mm and endometrial thickness is 6-8 mm in sonography, 5000 IU of HCG ampoule (Choriomon, IBSA, Switzerland), intramuscular will be injected. Pregnancy. Timepoint: Last day of receiving progesterone suppository. Method of measurement: Blood test. Vice chancellor of research, Kashan University of Medical Sciences Approved 2010-01-20 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Blvd , Pezeshk Blvd Kashan Iran (Islamic Republic of)