Abstract
Research question
Are QL1012 and Gonal-f® equivalent in women undergoing ovarian stimulation for assisted
reproductive technology (ART)?
Design
This multicentre, randomized, assessor-blinded, phase-three trial was conducted at
13 centres in China. Eligible patients were infertile women; age 20–39 years; body
mass index 18–30 kg/m2; regular menstrual cycles; and indication for ART. After successful pituitary downregulation,
patients were randomly assigned (1:1) to receive QL1012 or Gonal-f®, stratified by
age (initial dose of 75–150 IU for women younger than 30 years, 150–225 IU for women
aged 30–34 years and 225–300 IU for women aged ≥35 years, subcutaneously, once daily).
The primary end point was the number of oocytes retrieved.
Results
Between October 2018, and June 2019, 341 patients were included in the per-protocol
set. The mean numbers of oocytes retrieved were 14.7 ± 7.0 in the QL1012 group (n = 169) and 13.4 ± 6.1 in the Gonal-f® group (n = 172). Adjusted by analysis of covariance model, the least-squares mean difference
was 1.3 oocytes (95% CI –0.1 to 2.7; P = 0.0650), within the pre-defined equivalence margins of ±3.0. Similar results were
observed in the full analysis set. Additionally, no statistical differences were found
in secondary end points except oestradiol concentration (median 3948.0 pg/ml versus
3545.3 pg/ml; P = 0.0015). Ovarian hyperstimulation syndrome (12.4% versus 13.1 %) and other adverse
events were similar between the two groups.
Conclusions
Therapeutic equivalence and similar safety profiles were demonstrated between QL1012
and Gonal-f® in women undergoing ovarian stimulation for ART.
KEYWORDS
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Biography
Professor Yingpu Sun is Chief Physician of the Reproductive Medicine Center at First Affiliated Hospital of Zhengzhou University. As a specialist in reproductive medicine, she has successively completed multiple national first cases using advanced assisted reproductive technology.
Article info
Publication history
Published online: October 16, 2022
Accepted:
October 12,
2022
Received in revised form:
September 20,
2022
Received:
April 28,
2022
Declaration: Jie Wang and Fang Ma are employees of Qilu Pharmaceutical Co., Ltd.Identification
Copyright
© 2022 Published by Elsevier Ltd on behalf of Reproductive Healthcare Ltd.
