Clinical utility of newly developed highly purified human menopausal gonadotrophins: a randomized controlled trial.
The aim of this study was to evaluate the safety and efficacy of IVF-M HP, a newly developed highly purified human menopausal gonadotrophin preparation, for ovarian stimulation in women with infertility undergoing IVF, intracytoplasmic sperm injection (IVF-ICSI) and embryo transfer using a GnRH antagonist protocol. This was a multicentre, randomized, active-controlled, parallel design, open-label, non-inferiority clinical study. Of the 112 patients randomized for treatment using the GnRH antagonist protocol, 111 were treated. No significant difference was found in the number of oocytes retrieved from the IVF-M HP and Menopur groups (13.1 ± 7.6 versus 10.3 ± 6.7, respectively). The lower limit of the one-sided 97.5% confidence interval for the difference between the groups was -0.25, i.e., greater than the pre-defined non-inferiority margin (-5). Therefore, the IVF-M HP treatment was considered non-inferior to Menopur. Furthermore, no significant difference was observed between the groups in the number of good-quality oocytes, leading follicles, good-quality embryos, or in fertilization, implantation, positive beta-HCG and clinical pregnancy rates. The safety analysis revealed that 40.4% and 35.2% in the IVF-M HP and Menopur groups, respectively, reported adverse events. In conclusion, IVF-M HP had comparable clinical efficacy and safety profiles to Menopur.
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Cheil General Hospital and Women's Healthcare Center, Dankook University College of Medicine, South Korea.
Hwa Seon
HS
Koo
Department of Obstetrics and Gynecology, CHA Fertility Center of Bundang CHA General Hospital, CHA University, Seongnam, South Korea.
Hwang
H
Kwon
Infertility Clinic, Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Doo Seok
DS
Choi
Clinical Development Department, LG Life Science, Seoul, South Korea.
Song
S
Han
Clinical Development Department, LG Life Science, Seoul, South Korea.
Jung Youn
JY
Seo
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Cheil General Hospital and Women's Healthcare Center, Dankook University College of Medicine, South Korea. Electronic address: km1yang@naver.com.
Kwang Moon
KM
Yang
D000328:Adult; D005260:Female; D006062:Gonadotropins / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008593:Menopause; D011247:Pregnancy; D018873:Pregnancy Rate; D016896:Treatment Outcome
D006062:Gonadotropins
Gonadotropin-releasing hormone antagonist protocol; Highly purified HMG; In vitro fertilization; Infertility; Number of oocytes