Clinical application of domestic recombinant human follicle-stimulating hormone in controlled ovarian hyperstimulation with assisted reproductive technology
10.3760/cma.j.cn101441-20200408-00199
- VernacularTitle:国产重组人促卵泡激素在辅助生殖技术控制性超促排卵的临床应用
- Author:
Rui YANG
1
;
Xiaoyan LIANG
;
Yimin ZHU
;
Yanping LI
;
Dongzi YANG
;
Feiyang DIAO
;
Ping YIN
;
Tingting LI
;
Aixia LIU
;
Yumei LI
;
Lin LI
;
Jing WANG
;
Huangguo XIONG
;
Rong LI
Author Information
1. 北京大学第三医院 100191
- Publication Type:Journal Article
- Keywords:
Domestic recombinant human follicle-stimulating hormone;
Controlled ovarian hyperstimulation;
Efficacy;
Safety
- From:
Chinese Journal of Reproduction and Contraception
2021;41(2):113-119
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of domestic recombinant human follicle-stimulating hormone (rhFSH) in assisted reproductive technology (ART) of controlled ovarian hyperstimulation (COH).Methods:In a multicenter, randomized, double-blind, positive, parallel controlled non-inferiority clinical trial, the infertile women with normal ovarian reserve who received ART-COH in six reproductive medical centers from July 2017 to June 2019 were randomly divided into two groups: experimental group (domestic rhFSH, n=134) and control group (imported rhFSH, n=133). Eight subjects were excluded due to various reasons during the experimental process, 7 in experimental group and 1 in control group. At last, 127 subjects in experimental group and 132 subjects in control group complete the experiment following the research protocol. The total number of oocytes, usage of FSH, fertilization rate of oocytes, the number of high-quality embryos, clinical pregnancy rate, live birth rate, neonatal characteristics 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 13.0±5.8 and 12.9±5.7, respectively, with no statistically significant difference ( P>0.05). Among the 82 intracytoplasmic sperm injection (ICSI) patients, the number of M II oocytes obtained in experimental group (39 cases) was markedly higher than that in control group (43 cases) (9.9±3.9 vs. 7.5±3.0, P=0.003). The fertilization rate of oocytes in experimental group was obviously higher than that in control group [63.82% (1048/1642) vs. 56.19% (958/1705), P<0.001]. There were no significant differences of stimulated duration and dosage of rhFSH, number of high-quality embryos, clinical pregnancy rate, preterm rate, live birth rate, incidence of neonatal abnormalities, neonatal weight or Apgar score between the two groups (all P>0.05). The incidence of ovarian hyperstimulation syndrome 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 rhFSH. Conclusion:The efficacy and safety of domestic rhFSH were the same as that of imported rhFSH in infertile patients with normal ovarian reserve under the same ovarian stimulation regimen.
