]>
IRCT201109163386N4 IRCT 2011-10-01 Semnan University of Medical Sciences Comparison of controlled ovarian stimulation with clomiphen citrate HMG(Human menopausal gonadotropin) or clomiphen citrate rFSH(recombinant follicule stimulating hormon) in IUI(Intrauterine Insemination) cycles. Comparison of controlled ovarian stimulation with clomiphen citrate HMG(Human menopausal gonadotropin) or clomiphen citrate rFSH(recombinant follicule stimulating hormon) in IUI(Intrauterine Insemination)cycles. 2009-06-18 anticipated 142 Complete https://irct.ir/trial/3467 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Condition 1: Unexplained infertility. Condition 2: Male factor infertility. Intervention 1: Ovarian cycle stimulation was started on the 3rd day of menstruation after the basal transvaginal ultrasound (TV-USG) with 100 mg CC for 5 consecutive days.The gonadotropin regimens adopted in each group was HMG 75 IU (Merional HP,Serono,Turkey ) ,intramuscular,daily from day 7 of menstrual cycle.(If older than 35 years old 150 IU was given). TV-USG was started from day 9 of menstrual cycle every other day for follicular size tracing.The gonadotropin dose was continued until the occurrence of at least one ovarian follicule ≥16 mm in diameter,then HCG (Profasi,Serono,Turkey) 10'000 IU was administered intramuscularly to trigger final follicular maturation and IUI with a sperm swim-up procedure was performed 35-36 hours later with Wallace Artificial Insemination Catheter(UK) SMITHS .For prevention of OHSS ovulation was induced by 0.5 cc GnRH-a (superfact….) if there were ≥5 follicles with a diameter of ≥ 16 mm at the time of induction. The luteal phase was supported with 400 mg of vaginal progesterone suppository (Cyclogest,Actavis,UK)twice a day administered from the day of IUI for two weeks.A blood sample for βHCG (beta human chorionic gonadotropin) were obtained two weeks after IUI for pregnancy confirmation.A clinical pregnancy was determined by the visualization of an embryo with cardiac activity at 7 weeks of gestation in TV-USG.In case of pregnancy progesterone was continued till 12 weeks of gestation. Intervention 2: Ovarian cycle stimulation was started on the 3rd day of menstruation after the basal transvaginal ultrasound (TV-USG) with 100 mg CC for 5 consecutive days.The gonadotropin regimens adopted was rFSH 75 IU (Gonal F,Serono,Turkey),subcutaneous from day 7 of menstrual cycle.(If older than 35 years old 150 IU was given) TV-USG was started from day 9 of menstrual cycle every other day for follicular size tracing.The gonadotropin dose was continued until the occurrence of at least one ovarian follicule ≥16 mm in diameter,then HCG (Profasi,Serono,Turkey) 10'000 IU was administered intramuscularly to trigger final follicular maturation and IUI with a sperm swim-up procedure was performed 35-36 hours later with Wallace Artificial Insemination Catheter(UK) SMITHS.For prevention of OHSS ovulation was induced by 0.5 cc GnRH-a (superfact….) if there were ≥5 follicles with a diameter of ≥ 16 mm at the time of induction. The luteal phase was supported with 400 mg of vaginal progesterone suppository (Cyclogest,Actavis,UK)twice a day administered from the day of IUI for two weeks.A blood sample for βHCG (beta human chorionic gonadotropin) were obtained two weeks after IUI for pregnancy confirmation.A clinical pregnancy was determined by the visualization of an embryo with cardiac activity at 7 weeks of gestation in TV-USG.In case of pregnancy progesterone was continued till 12 weeks of gestation .
public Marjan Bahrami
Amir al momenin Hospital
Semnan Iran (Islamic Republic of) 3519734731 +98 23 1446 0088 bahrami.marjan@yahoo.com Semnan University of Medical Sciences scientific Azam Azargoon
Amir al momenin Hospital
Semnan Iran (Islamic Republic of) 3519734731 +98 23 1446 0088 a-azargoon@sem-ums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: history of infertility of more than 1 year; wemon's age between 20 and 40 years old; documentation of normal ovulatory cycles; normal TSH and Prolactin level; normal reproductive hormones in the early follicular phase;patent tubes have been shown by HSG or laparoscopy; normal sperm count, motility and morphology according to the World Health Organization criteria(WHO 1992)in unexplained infertility and total motile sperm count more than 1 million in male factor infertility. 20 years 40 years Female n97.9 n46 Female infertility, unspecified Oligospermia NOS Treatment - Drugs Treatment - Drugs Ovarian cycle stimulation was started on the 3rd day of menstruation after the basal transvaginal ultrasound (TV-USG) with 100 mg CC for 5 consecutive days.The gonadotropin regimens adopted in each group was HMG 75 IU (Merional HP,Serono,Turkey ) ,intramuscular,daily from day 7 of menstrual cycle.(If older than 35 years old 150 IU was given). TV-USG was started from day 9 of menstrual cycle every other day for follicular size tracing.The gonadotropin dose was continued until the occurrence of at least one ovarian follicule ≥16 mm in diameter,then HCG (Profasi,Serono,Turkey) 10'000 IU was administered intramuscularly to trigger final follicular maturation and IUI with a sperm swim-up procedure was performed 35-36 hours later with Wallace Artificial Insemination Catheter(UK) SMITHS .For prevention of OHSS ovulation was induced by 0.5 cc GnRH-a (superfact….) if there were ≥5 follicles with a diameter of ≥ 16 mm at the time of induction. The luteal phase was supported with 400 mg of vaginal progesterone suppository (Cyclogest,Actavis,UK)twice a day administered from the day of IUI for two weeks.A blood sample for βHCG (beta human chorionic gonadotropin) were obtained two weeks after IUI for pregnancy confirmation.A clinical pregnancy was determined by the visualization of an embryo with cardiac activity at 7 weeks of gestation in TV-USG.In case of pregnancy progesterone was continued till 12 weeks of gestation. Ovarian cycle stimulation was started on the 3rd day of menstruation after the basal transvaginal ultrasound (TV-USG) with 100 mg CC for 5 consecutive days.The gonadotropin regimens adopted was rFSH 75 IU (Gonal F,Serono,Turkey),subcutaneous from day 7 of menstrual cycle.(If older than 35 years old 150 IU was given) TV-USG was started from day 9 of menstrual cycle every other day for follicular size tracing.The gonadotropin dose was continued until the occurrence of at least one ovarian follicule ≥16 mm in diameter,then HCG (Profasi,Serono,Turkey) 10'000 IU was administered intramuscularly to trigger final follicular maturation and IUI with a sperm swim-up procedure was performed 35-36 hours later with Wallace Artificial Insemination Catheter(UK) SMITHS.For prevention of OHSS ovulation was induced by 0.5 cc GnRH-a (superfact….) if there were ≥5 follicles with a diameter of ≥ 16 mm at the time of induction. The luteal phase was supported with 400 mg of vaginal progesterone suppository (Cyclogest,Actavis,UK)twice a day administered from the day of IUI for two weeks.A blood sample for βHCG (beta human chorionic gonadotropin) were obtained two weeks after IUI for pregnancy confirmation.A clinical pregnancy was determined by the visualization of an embryo with cardiac activity at 7 weeks of gestation in TV-USG.In case of pregnancy progesterone was continued till 12 weeks of gestation . Clinical pregnancy rate. Timepoint: 7 weeks of gestation. Method of measurement: Fetal heart activity with ultrasound. Ongoing pregnancy rate. Timepoint: 12 weeks of gestation. Method of measurement: Fetal heart activity with ultrasound. Mean of follicular size on the day of HCG administration. Timepoint: Day of occurrence of at least one ovarian follicule ≥16 mm in diameter. Method of measurement: Ultrasound. Endometrial thickness on the day of HCG administration. Timepoint: Day of occurrence of at least one ovarian follicule ≥16 mm in diameter. Method of measurement: Ultrasound. Total dose of gonadotropin. Timepoint: Day of occurrence of at least one ovarian follicule ≥16 mm in diameter. Method of measurement: Number of vials. Duration of stimulation with gonadotropin. Timepoint: Day of occurrence of at least one ovarian follicule ≥16 mm in diameter. Method of measurement: Number of days gonadotropin was administered. Number of dominant follicles on the day of HCG administration. Timepoint: Day of occurrence of at least one ovarian follicule ≥16 mm in diameter. Method of measurement: Number of dominant follicles. Semnan University of Medical Sciences Approved 2009-06-17 Semnan University of Medical Sciences Semnan University of Medical Sciences, Basij-blvd Semnan Iran (Islamic Republic of)