Efficacy and safety of domestic produced recombinant human chorionic gonadotropin in Chinese women undergoing controlled ovarian hyperstimulation : a randomized controlled trial
10.3760/cma.j.cn101441-20211118-00508
- VernacularTitle:国产重组人绒毛膜促性腺激素用于中国女性控制性超促排卵治疗中的有效性与安全性：一项随机对照研究
- Author:
Ying SONG
1
;
Rong LI
;
Jie QIAO
;
Qi YU
;
Lei JIN
;
Wangming XU
;
Dongzi YANG
;
Jianqiao LIU
;
Yimin ZHU
Author Information
1. 北京大学第三医院妇产科，北京100191
- Publication Type:Journal Article
- Keywords:
Controlled ovarian hyperstimulation;
Domestic recombinant human chorionic gonadotropin;
Efficacy;
Safety
- From:
Chinese Journal of Reproduction and Contraception
2022;42(3):239-244
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of domestic recombinant human chorionic gonadotropin (r-hCG) for injection in Chinese women undergoing assisted reproductive technology (ART) of controlled ovarian hyperstimulation (COH).Methods:In a multicenter, randomized, double-blind, positive, parallel controlled clinical trial, the infertile women with normal ovarian reserve who received COH in seven reproductive medical centers from July 2017 to October 2018 were randomly divided into two groups: experimental group (domestic r-hCG, n=112) and control group (imported r-hCG, n=116). Interactive web response system was used to randomize. The total number of oocytes obtained, cleavage cells, two pronuclei fertilization, mid-division oocytes rate, positive serum hCG rate, early embryo loss rate, clinical pregnancy rate, sustained pregnancy rate and the incidence of adverse reactions were compared between the two groups during the cycle of COH. Results:During the initiation cycle of ovulation induction therapy, the total number of oocytes obtained in experimental group and control group were (12.1±5.6) and (12.0±6.7) respectively, with no statistically significant difference ( P>0.05). There were no significant differences in the rate of mid-division oocytes, the number of cleavage cells, the number of double pronuclear fertilization, the positive rate of serum hCG during the transplantation cycle, the loss rate of early embryo, the clinical pregnancy rate, and the sustained pregnancy rate between the two groups (all P>0.05), and the 90% confidence interval ( CI) of the difference between the two groups fell within the preset equivalence threshold (-3, +3). The difference in immunogenicity assessment between the two groups was not statistically significant ( P>0.05). The incidence of ovarian hyperstimulation syndrome (OHSS) and other adverse reactions in treatment period were not significantly different between the two groups (all P>0.05), which were known adverse reaction occurred in the imported r-hCG. Conclusion:In the COH cycle of Chinese infertile women with normal ovarian reserve, the effectiveness and safety of domestic r-hCG are equivalent to imported r-hCG.
