ABSTRACT: This study compared the efficacy and safety of two highly purified (HP) human menopausal gonadotropin (hMG) preparations, Gynogen HP and Menopur, in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF). A multicenter, randomized, active-controlled noninferiority comparative study was conducted between 2019 and 2021. Women aged 21-40 undergoing COS for their first or second IVF cycle, with or without intracytoplasmic sperm injection, were randomized to receive either Gynogen HP or Menopur. The primary endpoint was to determine the total number of oocytes retrieved. Key secondary endpoints included total hMG dose, days of hMG stimulation, fertilization rate, implantation rate, clinical pregnancy rate and safety. A total of 150 patients were randomized into two groups: 77 received Gynogen HP and 73 received Menopur COS. The primary endpoint, the number of oocytes retrieved (mean ± standard deviation (SD)), was similar between the Gynogen HP (6.3 ± 3.39) and Menopur (6.7 ± 4.52) groups. The least square (LS) mean values were 5.9 for the Gynogen HP and 6.3 for Menopur, with an LS mean difference of - 0.4 (95% CI: -1.83, 1.07; P = 0.6067), indicating that noninferiority as the lower limit of the 95% CI was above the non-inferiority threshold of -2.0. Secondary efficacy endpoints and safety analysis showed no significant differences between groups. Gynogen HP is noninferior and therapeutically equivalent to Menopur in terms of the number of oocytes retrieval, with a comparable safety profile. These results support the use of Gynogen HP for COS in women undergoing IVF as a part of assisted reproduction techniques.
LAY SUMMARY: This study compared two fertility medications (Gynogen HP and Menopur) that are used to help women recruit eggs for IVF treatment. The researchers assessed if these medications are equally potent and safe. The study involved 150 women undergoing their first or second round of IVF between 2019 and 2021. Half of the women received Gynogen HP, while another half received Menopur. The main finding was that both medications worked similarly - women on Gynogen HP recruited an average of 6.3 eggs, while those on Menopur recruited an average of 6.7 eggs. This small difference was not meaningful from a medical perspective. Other important factors, such as pregnancy rates and safety concerns, were also similar between the two medications. Researchers concluded that Gynogen HP works just as well as Menopur for IVF treatment and is equally safe to use. This means doctors can confidently prescribe either medication for women undergoing IVF.