Real-world utilization of gonadotropins and the associated cumulative live birth rates in the United States: a retrospective claims database analysis.
HP-hMG use has increased and is associated with higher odds of live birth compared to follitropin alfa in women undergoing fertility treatments.
Where it sits
this study against the rest of the hmg (human menopausal gonadotropin) corpusSummary and findings
This study assessed the real-world utilization of gonadotropins, including Human Menopausal Gonadotropin (HP-hMG), and the associated cumulative live birth rates (CLBR) in US women with infertility. The analysis included 14,174 women aged 18-42 years who received gonadotropins after an infertility diagnosis. It was found that HP-hMG use increased during the study period and was associated with higher odds of live birth compared to follitropin alfa monotherapy.
Abstract
<h4>Background/aims</h4>Gonadotropins approved in the United States (US) for ovarian follicle stimulation and pregnancy include follitropin alfa, follitropin beta, and Highly Purified Human Menopausal gonadotropin (HP-hMG). This study assessed the real-world utilization of these gonadotropins and associated cumulative live birth rates (CLBR) in US women with infertility.<h4>Methods</h4>Females (age 18-42 years) who received gonadotropins after infertility diagnosis were identified from the IQVIA PharMetrics Plus database (1/2016-6/2022). Four cohorts were constructed based on the treatment on the index date (first gonadotropin use): HP-hMG monotherapy, follitropin alfa monotherapy, follitropin beta monotherapy, and mixed protocol (HP-hMG with follitropin alfa or follitropin beta). Gonadotropin utilization and incidence of ovarian hyperstimulation syndrome (OHSS) and severe OHSS were described during 2016-2021. CLBR was assessed for the first live births associated with the index gonadotropin regimen using logistic regression adjusting for baseline characteristics.<h4>Results</h4>Among 14,174 women, the mean age was 34.7 (SD: 4.1) years, with 47.1% <35 years. During 2016-2021, HP-hMG use in a mixed protocol (60.1-71.2%) or as monotherapy (4.3-5.7%) increased, while use of follitropin alfa (21.7-11.4%) and follitropin beta (13.9-11.6%) monotherapy decreased. Compared to follitropin alfa, the adjusted odds of live birth were significantly higher after the mixed protocol (OR [95% CI]: 1.31 [1.20-1.45]) and HP-hMG monotherapy (1.28 [1.08-1.53]); the estimate for follitropin beta versus follitropin alfa was closer to the null (0.96 [0.84-1.10]). The rate of OHSS was low across all cohorts (1.2-2.9%) and severe OHSS was rare (0.1%).<h4>Limitations</h4>As an observational analysis lacking data on key predictors of IVF success, associations should not be interpreted as comparative efficacy.<h4>Conclusions</h4>In US women with infertility, HP-hMG as monotherapy or in a mixed protocol increased in use during 2016-2021 and was associated with higher odds of CLBR compared to follitropin alfa monotherapy.
Background
This paper addresses the utilization of gonadotropins for ovarian stimulation in women with infertility, focusing on Human Menopausal Gonadotropin (HP-hMG). Prior studies have indicated various gonadotropins' roles in fertility treatments, but real-world data on their comparative effectiveness and utilization trends are limited. Understanding these trends is essential for clinicians to make informed decisions regarding fertility treatments.
Methods
The study utilized a retrospective claims database analysis from the IQVIA PharMetrics Plus database, covering the period from January 2016 to June 2022. The population included females aged 18-42 years who received gonadotropins after an infertility diagnosis, with a total sample size of 14,174. Four cohorts were constructed based on the type of gonadotropin used on the index date, and cumulative live birth rates were assessed using logistic regression.
Results
The primary endpoint indicated that the adjusted odds of live birth after the mixed protocol was 1.31 (95% CI: 1.20-1.45) compared to follitropin alfa. The study reported a low incidence of OHSS, ranging from 1.2% to 2.9%, with severe OHSS occurring at a rate of 0.1%. The findings suggest an increase in HP-hMG utilization and its association with higher odds of live birth.
Interpretation
These findings suggest that HP-hMG may be associated with better outcomes compared to follitropin alfa, although the effect size is modest. The study's observational nature and lack of control for key IVF success predictors limit the ability to draw definitive conclusions about comparative efficacy. Clinicians should consider these limitations when interpreting the results and applying them to practice.
Key findings
- Mean age was 34.7 years (SD: 4.1), with 47.1% <35 years.
- HP-hMG use in a mixed protocol increased from 60.1% to 71.2% during 2016-2021.
- Adjusted odds of live birth after mixed protocol was 1.31 (95% CI: 1.20-1.45) compared to follitropin alfa.
- Adjusted odds of live birth after HP-hMG monotherapy was 1.28 (95% CI: 1.08-1.53) compared to follitropin alfa.
- Rate of ovarian hyperstimulation syndrome (OHSS) was 1.2-2.9% across all cohorts.
- Severe OHSS was rare at 0.1%.
Limitations
- Observational analysis lacking data on key predictors of IVF success.
- Single-site data may not represent broader population trends.
- Potential confounding factors not controlled for in analysis.
- Short follow-up period may not capture long-term outcomes.