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IRCT138805061141N3 IRCT 2009-11-14 Reproductive Medicine Research Center, Royan Institute, ACECR Micro dose HCG in PCOS patients with previous Clomiphene Citrate (CC)-resistant anovulation Comparison of micro-dose human chorionic gonadotropin (hCG) with HMG in PCOS patients with previous Clomiphene Citrate (CC)-resistant anovulation 2009-06-01 anticipated 250 Complete https://irct.ir/trial/198 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 1-2 PCOS patients with clomid failure. Intervention 1: 100 mg Clomiphene citrate on days 3 to 7 of cycle and 150 mg human menopausal gonadotropin (HMG) during days 7, 8, and 9. Intervention 2: 100 mg Clomiphene citrate plus 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily when the largest follicle is 12 mm or larger mean diameter. Intervention 3: 100 mg Clomiphene citrate plus 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily From day 9 (without attention to follicle size).
public Dr. Mahnaz Ashrafi
Banihashem square, Eastern Hafez Avenue
Tehran Iran (Islamic Republic of) +98 21 2356 2000 ashrafim@royaninstitute.org Reproductive Medicine Research Center, Royan Institute, ACECR scientific Dr. Mahnaz Ashrafi
Banihashem squrae, Eastern Hafez Street
Tehran Iran (Islamic Republic of) +98 21 2356 2000 ashrafim@royaninstitute.org Reproductive Medicine Research Center, Royan Institute, ACECR Iran (Islamic Republic of) Inclusion criteria: age under 30 years, primary infertility, PCOS diagnosed by the Rotterdam criteria, by two of the following three features: 1) oligo or anovulation, 2) clinical and/or biochemical signs of hyper androgenism, or 3) polycystic ovaries, previously documented dominant follicle or follicles (R12 mm mean diameter) on transvaginal Ultrasound follicular monitoring, Normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy, normal fasting glucose and insulin levels, normal serum prolactin, and thyroid stimulating hormone, Estradiol, Progesterone, FSH and dehydroepiandrosterone sulfate levels, normal semen analysis by World Health Organization criteria Exclusion Criteria: previous history of IVF or ICSI treatments, history of hormonal treatment within three month prior to admission (Except OCP, progesterone), history of ovarian cutter or Ovarian drilling, BMI higher than 30, presence of ovarian cyst (more than 30 mm) during third cycle ultrasound 18 years 30 years Female E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Treatment - Drugs 100 mg Clomiphene citrate on days 3 to 7 of cycle and 150 mg human menopausal gonadotropin (HMG) during days 7, 8, and 9 100 mg Clomiphene citrate plus 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily when the largest follicle is 12 mm or larger mean diameter 100 mg Clomiphene citrate plus 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily From day 9 (without attention to follicle size) Multiple pregnancy rates. Timepoint: one to 10 days after pregnancy test and after BHCG more than 1000. Method of measurement: observation of gestational sac with fetal heart rate by sonography. Ovarian hyperstimulation syndrom. Timepoint: at ovum puncture day, at embryo transfer day and three days after embryo transfer. Method of measurement: clinical symptoms, follicle numbers by sonography, serum estradiol level. Clinical Pregnancy rate. Timepoint: one to ten days after positive serum BHCG. Method of measurement: sonography and observation of gestational sac. Implantation rate. Timepoint: 1 to 10 days after positive BHCG. Method of measurement: ratio between observed gestational sac and total number of embryo transfered. Cancellation rate. Timepoint: after ovarian stimulation, after insemination in lab, after embryo transfer. Method of measurement: lack of follicle or oocyte by sonography, lack of embryo in lab, and OHSS. Miscarriage rate. Timepoint: during first 12 weeks after pregnancy. Method of measurement: clinical symptoms and sonographic criteria. Endometer stage. Timepoint: at day 9 of cycle, and repeat every 48 hours. Method of measurement: sonography. NCT00947713 ClinicalTrials.gov Reproductive Medicine Research Center, Royan Institute, ACECR Approved 1388-06-24 Reproductive Medicine Research Center, Royan Institute, ACECR Banihashem square, Eastern Hafez Avenue. Tehran Iran (Islamic Republic of)