| Purpose:Ovulation-stimulating drugs are often used in the treatment of Assisted Reproductive Technology(ART),and the commonly used ovulation-stimulating drugs in the clinic are recombinant human follicle-stimulating hormone injection(Trade name:Gonal-F~?).Alphamab(Jilin)Co.,Ltd.developed a biosimilar drug for Gonal-F~?,code:LM001.This study mainly explores the safety and efficacy of LM001and Gonal-F~?in the implementation of controlled hyperovulation induction in assisted reproductive technology.Methods:From April 2019 to May 2021,a total of 280 married women in need of assisted reproductive treatment were enrolled in 8 hospitals nationwide,and were randomly assigned to the trial group(injecting LM001)or the control group(injecting Gonal-F~?)1:1.All subjects must meet the inclusion criteria and not the exclusion criteria.After pretreatment and successful deregulation,the group is admitted to the group and undergoes superovulation treatment,and continues to use LM001 or Gonal-F~?for7-16 days.The main index is to compare the total number of oocytes obtained after the injection of recombinant human chorionic gonadotropin injection.Secondary indicators are:the total injection dose and time(days)of the drug for the test,the E2level on the day of the injection of the recombinant human chorionic gonadotropin injection and the total number of follicles with a diameter of≥14 mm on the day;the fertilization rate;the embryo transfer rate;the pregnancy rate;and the positive HCG rate.At the same time,the occurrence of adverse events such as ovarian hyperstimulation syndrome(OHSS)and pregnancy outcomes was evaluated.The data analysis was conducted using SAS 9.4 software,and all statistical tests were bilateral unless otherwise specified,with P≤0.05 indicating statistical significance.Descriptive analysis:the classification data uses the number of cases and composition ratio;the measurement data uses mean,standard deviation,maximum,minimum,and median.Results:A total of 280 patients were enrolled.The results were as follows:1.The least-squares mean of the total number of oocytes in the test group and the control group were 13.4(±0.62)and 12.7(±0.62),respectively,the difference of the least-squares mean of the total number of oocytes obtained per capita in the two groups(LM001-Gonal-F~?)was 0.7(±0.76)and 95%CI[-0.8,2.2].Within the equivalent bound value[-3,3]specified by the scheme.2.Total injection dose and time(days)of the drug used in the trial of the two groups of patients,total E2 levels and total follicles≥14 mm in diameter on the day of recombinant human velvet injection,the pregnancy Rate;positive rate of HCG,no statistical difference between the two groups(P>0.05).3.The adverse reaction spectrum,incidence and severity of the two groups of subjects were similar,and the overall turnaround was good.Conclusion:LM001 was equivalent to Gonal-F~?in terms of the clinical efficacy in female subjects undergoing controlled ovarian hyperstimulation in assisted reproduction. |
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