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IRCT201107034339N2 IRCT 2011-08-09 Yazd University of Medical Sciences comparison the effect of two kind of HCG in IVF cycle IVF comparison the effect of Recombinant HCG and urinary HCG in infertile women at IVF cycle 2009-01-01 anticipated 200 Complete https://irct.ir/trial/4616 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: camputerized randomization by opening sealed envelopes. N/A female infertility. Intervention 1: Intervention group: Patients undergo pituitary desensitization with Decapeptyl 0.1 mg/day (Decapeptyl® 0.1 mg, Ferring, Germany)starting in the mid luteal phase and was continued until the day of the administration of HCG. Treatment with Gonal-F(Gonal-F, Serono, Aubnne, Switzerland) is started at the second day of menstruation .The ovarian response is monitored by vaginal sonography and the dose is adjusted accordingly triggering of final follicular maturation with r- HCG (Ovidrel)(interventional group) is performed in the evening. Oocyte is retrieved by follicular aspiration 34-36 hrs after r-hcG or U-hcG. Up to three embryos are replaced in the uterine cavity on day 3after ovum pick up. Luteal phase support is designed by 100mg progesterone intra muscular injection per day. After 14 days of embryo transfer βHCG is checked and clinical pregnancy is documented by vaginal sonography at 3weeks after positive βHCG. Intervention 2: Patients undergo pituitary desensitization with Decapeptyl 0.1 mg/day (Decapeptyl® 0.1 mg, Ferring, Germany)starting in the mid luteal phase and was continued until the day of the administration of HCG. Treatment with Gonal-F (Gonal-F, Serono, Aubnne, Switzerland) is started at the second day of menstruation .The ovarian response is monitored by vaginal sonography and the dose is adjusted accordingly triggering of final follicular maturation with U- HCG (control group) (pregnyl, ® organon, oss, Netherlands) is performed in the evening. Oocyte is retrieved by follicular aspiration 34-36 hrs after r-hcG or U-hcG. Up to three embryos are replaced in the uterine cavity on day 3after ovum pick up. Luteal phase support is designed by 100mg progesterone intra muscular injection per day. After 14 days of embryo transfer βHCG is checked and clinical pregnancy is documented by vaginal sonography at 3weeks after positive βHCG. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4169847/ Background: Human chorionic gonadotropin (HCG) has been used as a replacement for the mid-cycle luteinizing hormone (LH) surge for several years. The recent arrival of recombinant DNA technology has made recombinant HCG (rHCG) accessible. Objective: To assess efficacy of rHCG compared to urinary HCG (uHCG) for triggering of ovulation and induction of final oocyte maturation in assisted reproductive cycles. Materials and Methods: 200 patients who were candidate for ICSI were randomly divided in two groups. In group I (rHCG), patients received 250µg of rHCG for final oocyte maturation, and in group II (uHCG) the patients received 10000 IU of uHCG. Measured outcomes were number of retrieved oocyte and mature oocyte, maturation rate of oocyte, fertilization rate and clinical pregnancy rate. Results: The rates of oocyte maturity were similar in both groups. Fertilization rate was similar in two groups (58.58% in rHCG group versus 60.58% in uHCG group p=0.666). The clinical pregnancy rate per cycle was similar in both group 34.0% in rHCG group versus 39% in uHCG group (p=0.310). Conclusion: We demonstrated that rHCG is as effective as uHCG, when it is used for final oocyte maturation in ICSI cycles. The numbers of retrieved oocyte and maturation rates were similar in both groups; also fertilization and clinical pregnancy rates were similar. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the privacy of patients
public Dr.Maryam Eftekhar
Boali Street, Safaieh, Yazd, Research and clinical center
Yazd Iran (Islamic Republic of) 8916877391 +98 35 1824 7085 eftekhar@ssu.ac.ir Yazd University of Medical Sciences scientific Dr Maryam Eftekhar
Boali Street, Safaieh, Yazd, Research and clinical center
Yazd Iran (Islamic Republic of) 8916877391 +98 35 1824 7085 eftekhar@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) regular menstrual cycles age<38 years old FSH<10 IU/L BMI<30kg/m2 no limit 38 years Female history of metabolic or endocrine disorder history of pelvic surgery severe male factor infertilitywhich was defined as severe oligospermia (<5million sperm/ml),asthenospermia (5% progressive motility),or teratospermia (4% normal forms by strict criteria). N97 ناباروری زنان Treatment - Drugs Treatment - Drugs Intervention group: Patients undergo pituitary desensitization with Decapeptyl 0.1 mg/day (Decapeptyl® 0.1 mg, Ferring, Germany)starting in the mid luteal phase and was continued until the day of the administration of HCG. Treatment with Gonal-F(Gonal-F, Serono, Aubnne, Switzerland) is started at the second day of menstruation .The ovarian response is monitored by vaginal sonography and the dose is adjusted accordingly triggering of final follicular maturation with r- HCG (Ovidrel)(interventional group) is performed in the evening. Oocyte is retrieved by follicular aspiration 34-36 hrs after r-hcG or U-hcG. Up to three embryos are replaced in the uterine cavity on day 3after ovum pick up. Luteal phase support is designed by 100mg progesterone intra muscular injection per day. After 14 days of embryo transfer βHCG is checked and clinical pregnancy is documented by vaginal sonography at 3weeks after positive βHCG. Patients undergo pituitary desensitization with Decapeptyl 0.1 mg/day (Decapeptyl® 0.1 mg, Ferring, Germany)starting in the mid luteal phase and was continued until the day of the administration of HCG. Treatment with Gonal-F (Gonal-F, Serono, Aubnne, Switzerland) is started at the second day of menstruation .The ovarian response is monitored by vaginal sonography and the dose is adjusted accordingly triggering of final follicular maturation with U- HCG (control group) (pregnyl, ® organon, oss, Netherlands) is performed in the evening. Oocyte is retrieved by follicular aspiration 34-36 hrs after r-hcG or U-hcG. Up to three embryos are replaced in the uterine cavity on day 3after ovum pick up. Luteal phase support is designed by 100mg progesterone intra muscular injection per day. After 14 days of embryo transfer βHCG is checked and clinical pregnancy is documented by vaginal sonography at 3weeks after positive βHCG. Number and maturity of oocyte. Timepoint: ovum pick up. Method of measurement: by microscope. Chemical pregnancy. Timepoint: 14 days after embryo transfer. Method of measurement: blood. Yazd University of Medical Sciences Approved 2009-02-01 yazd research and clinical center for infertility Boali Street, Safaieh, Yazd, Research and clinical center Yazd Yazd Iran (Islamic Republic of)