A randomized, single-blind, parallel-controlled and multicentre study：compare the efficacy and safety of domestic and imported human recombinant FSH in WHO group Ⅱ anovulatory infertility
10.3760/cma.j.issn.0529-567x.2016.04.004
- VernacularTitle:国产与进口重组人FSH用于WHOⅡ类排卵功能障碍患者促排卵的多中心、盲法、随机对照Ⅲ期临床试验
- Author:
Yuanzheng ZHOU
;
Huan SHEN
;
Wenli ZUO
;
Yaohong XU
;
Xiaohui DENG
;
Yilu CHEN
;
Ying GAO
;
Xiuxia WANG
;
Wen XU
;
Qiaohong LAI
;
Hong SHI
;
Wei LIU
;
Qi HE
;
Fangfang HE
- Publication Type:Journal Article
- Keywords:
Anovulation;
Ovarian induction;
Follicle stimulating hormone,human;
Polycystic ovary syndrome;
Clinical trial,phaseⅢ
- From:
Chinese Journal of Obstetrics and Gynecology
2016;51(4):258-263
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of domestic human recombinant FSH (rhFSH) in women with anovulation of WHO groupⅡ. Methods A randomized, blind, parallel-controlled, non-inferiority and multicenter study was performed. A total of 534 admitted to 13 hospitals from May 2008 to August 2009. There were 531 women with ovulatory disorder was included in the statistical analysis, were randomly divided into test group (domestic rhFSH, n=352) and control group (imported rhFSH, n=179). Percentage of cycle with mature follicle, ovulation rate, clinical pregnancy rate, multiple pregnancy rate, ovarian hyperstimulation syndrome (OHSS) and adverse events were observed. Results No statistical significant differences (P>0.05) were observed between the two groups in terms of the efficiency on mature follicle [91.8%(323/352) versus 88.8%(159/179)], ovulation rate [91.3%(295/323) verus 90.6%(144/159)], clinical pregnancy rate [19.2%(62/323) verus 18.2%(29/159)], the number of the follicles<14 mm, the level of serum LH and progesterone, the thickness of endometrium on the day of hCG administration. The number of follicle≥18 mm and 14 mm≤follicle<18 mm and the level of serum estradiol on the day of hCG in the test group were significantly higher than those in the control group (P<0.05). The number of days of rhFSH administration in the test group was significantly less than that in the control group [(9.8±2.2) versus (11.4± 0.6) days, P<0.05], the dosage of rhFSH was significantly lower than that in the control group [(879 ± 419) versus (1 043 ± 663) U, P<0.05]. The multiple pregnancy rate in the test group was significantly higher than that in the control group [21% (13/62) versu 10% (3/29), P<0.05]. The incidence of OHSS and adverse events were similar between the two groups (P>0.05), and no other adverse events were observed in test group during treatment. Conclusion Ovarian stimulation with domestic rhFSH is effective, safe and economical in women with anovulation of WHO groupⅡ.
