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Войти в исследования Experimental cell research · 2026
Recombinant Human Follicle-Stimulating Hormone Injection versus Gonal-f® in Controlled Ovarian Stimulation for Assisted Reproductive Technology: A Multicenter, Randomized, Assessor-Blind, Active-Controlled Phase III Trial.
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Bai Haiyan, Li Jingjing, Wang Yang, Song Bing, Xu Xin, Sun Yongxin, Niu Qiuyun, Ma Caiyun, Xu Fan, Lin Jingjing, Cao Yunxia, Qiao Jie
Аннотация
OBJECTIVE: To evaluate the equivalence in the number of oocytes retrieved, as well as to compare the safety and immunogenicity between the recombinant human follicle-stimulating hormone injection (LZ-B-01) and Gonal-f® for controlled ovarian stimulation (COS) in assisted reproductive technology (ART).
METHODS: This multicenter, randomized, assessor-blind, active-controlled phase III trial enrolled 379 Chinese women with infertility undergoing ART. Participants were randomized to receive LZ-B-01 (n=189) or Gonal-f® (n=190). Subcutaneous injections were initiated on menstrual cycle day 2-3, with a fixed starting dose based on age and weight for the first five days, followed by dose adjustments according to ovarian response, with a maximum stimulation duration of up to 20 days. The primary endpoint was the number of oocytes retrieved 36±2 hours after trigger, with an equivalence margin set at ±3.0 oocytes. An ANCOVA model was fitted with treatment group as fixed effect, stratification factors and baseline antral follicle count (<15 vs. ≥15) as covariates. Secondary endpoints included gonadotropin dose, stimulation duration, follicular development, hormone levels, embryological/pregnancy outcomes, immunogenicity, and safety.
RESULTS: Baseline characteristics were balanced between groups. The least squares mean number of oocytes retrieved was 13.0 (95% CI: 12.1-13.9) in the LZ-B-01 group and 12.3 (95% CI: 11.4-13.2) in the Gonal-f® group, with a mean difference (LZ-B-01 minus Gonal-f®) of 0.7 oocytes (95% CI: -0.4 to 1.9), which fell entirely within the pre-specified equivalence margin of ±3.0 oocytes, confirming efficacy equivalence. Secondary efficacy endpoints, including gonadotropin dose, stimulation duration, embryological parameters, and pregnancy outcomes, were comparable between the the two groups. No treatment-emergent anti-drug antibodies were detected in either group. The incidence of treatment-emergent adverse events was comparable between the LZ-B-01 and Gonal-f® groups (59.6% vs. 60.0%).
CONCLUSION: LZ-B-01 demonstrated equivalent number of oocytes retrieved and a comparable safety profile to Gonal-f® for COS in ART, representing a suitable therapeutic alternative.
METHODS: This multicenter, randomized, assessor-blind, active-controlled phase III trial enrolled 379 Chinese women with infertility undergoing ART. Participants were randomized to receive LZ-B-01 (n=189) or Gonal-f® (n=190). Subcutaneous injections were initiated on menstrual cycle day 2-3, with a fixed starting dose based on age and weight for the first five days, followed by dose adjustments according to ovarian response, with a maximum stimulation duration of up to 20 days. The primary endpoint was the number of oocytes retrieved 36±2 hours after trigger, with an equivalence margin set at ±3.0 oocytes. An ANCOVA model was fitted with treatment group as fixed effect, stratification factors and baseline antral follicle count (<15 vs. ≥15) as covariates. Secondary endpoints included gonadotropin dose, stimulation duration, follicular development, hormone levels, embryological/pregnancy outcomes, immunogenicity, and safety.
RESULTS: Baseline characteristics were balanced between groups. The least squares mean number of oocytes retrieved was 13.0 (95% CI: 12.1-13.9) in the LZ-B-01 group and 12.3 (95% CI: 11.4-13.2) in the Gonal-f® group, with a mean difference (LZ-B-01 minus Gonal-f®) of 0.7 oocytes (95% CI: -0.4 to 1.9), which fell entirely within the pre-specified equivalence margin of ±3.0 oocytes, confirming efficacy equivalence. Secondary efficacy endpoints, including gonadotropin dose, stimulation duration, embryological parameters, and pregnancy outcomes, were comparable between the the two groups. No treatment-emergent anti-drug antibodies were detected in either group. The incidence of treatment-emergent adverse events was comparable between the LZ-B-01 and Gonal-f® groups (59.6% vs. 60.0%).
CONCLUSION: LZ-B-01 demonstrated equivalent number of oocytes retrieved and a comparable safety profile to Gonal-f® for COS in ART, representing a suitable therapeutic alternative.