Human menopausal gonadotrophin in a pre-filled injection pen is non-inferior to the US-approved powder formulation.
The HP-HMG pen formulation demonstrated non-inferiority to the powder formulation in terms of fertilized oocytes, but the clinical significance of the differences observed should be interpreted with caution.
Where it sits
this study against the rest of the hmg (human menopausal gonadotropin) corpusSummary and findings
This study evaluated the non-inferiority of highly purified human menopausal gonadotrophin (HP-HMG) in a pre-filled injection pen compared to the US-approved powder formulation in women undergoing ovarian stimulation. The primary endpoint was the number of fertilized oocytes, with a starting dose of 225 IU for the first 5 days. The results indicated non-inferiority of the pen formulation.
Abstract
Research question Is non-inferiority demonstrated for highly purified human menopausal gonadotrophin (HP-HMG) in an injection pen versus the US approved HP-HMG powder formulation for number of fertilized oocytes in women undergoing ovarian stimulation? Design Randomised, double-blind, double-dummy, parallel group, multicentre, non-inferiority trial at 19 US reproductive medicine centres enrolling 401 women ages 18‒42 years, randomised 1:1 to HP-HMG pen or HP-HMG powder. After downregulation in a gonadotropin-releasing hormone agonist (GnRHa) cycle, ovaries were stimulated with HP-HMG pen or HP-HMG powder at a starting dose of 225 IU for the first 5 days, with subsequent dose adjustments as needed. The number of fertilized (two pronuclei [2PN]) oocytes 19 ± 2 h after insemination was the primary end point. Results The primary end point was met, and HP-HMG pen was non-inferior to HP-HMG powder, with the mean ± SD number of fertilized 2PN oocytes 8.2 ± 5.5 and 6.6 ± 4.3, respectively (adjusted treatment difference: 1.50, 95% CI 0.57 to 2.42). The number of oocytes retrieved was 14.3 ± 8.1 with HP-HMG pen and 11.4 ± 6.3 with HP-HMG powder. The mean number of blastocysts was 4.8 ± 3.8 in the HP-HMG pen group and 3.9 ± 3.0 in the HP-HMG powder group. The ongoing pregnancy rate per started stimulation cycle was 45.0% in the HP-HMG pen group and 42.7% in the HP-HMG powder group and the live birth rate was 44.1% and 42.2% after fresh transfer, respectively. The incidence of early ovarian hyperstimulation syndrome was 3.5% in both groups. Conclusions HP-HMG as a solution for injection in a pre-filled injection pen is an effective and safe alternative to the approved powder formulation.
Background
The paper addresses the clinical question of whether a pre-filled injection pen formulation of Human Menopausal Gonadotropin (HMG) is as effective as the traditional powder formulation. Previous studies have established the efficacy of HMG in fertility treatments, but the convenience of a pre-filled pen may improve patient adherence. This study is significant as it explores a potentially more user-friendly option for administering HMG.
Methods
Not reported in abstract.
Results
Not reported in abstract.
Interpretation
Not reported in abstract.
Key findings
- Not reported in abstract.
Limitations
- Not reported in abstract.