REAL-WORLD INSIGHTS ON CONTROLLED OVARIAN STIMULATION FOR IVF/ICSI: DATA FROM A LARGE FERTILITY EMR DATABASE IN THE US (2010 - 2024)
Author(s)
Monica Yu, PhD1, Katie Barletta, MD, PhD1, Kevin Lan, Pharm.D2, Stu Field, PhD2, Cristian Merono, BSc2, Dani Goig, BSc2, Signe Møgelmose, PhD1, Dana Chuderland Ben Arie, PhD1, Eduardo Hariton, MD, MBA3, Wei Zhou, PhD1.
1Ferring Pharmaceuticals, Parsippany, NJ, USA, 2Cercle, Frisco, TX, USA, 3Reproductive Science Center of the SF Bay Area, San Francisco, CA, USA.
1Ferring Pharmaceuticals, Parsippany, NJ, USA, 2Cercle, Frisco, TX, USA, 3Reproductive Science Center of the SF Bay Area, San Francisco, CA, USA.
OBJECTIVES: Access to fertility care in the United States remains limited, and assisted reproductive technology (ART) practice patterns vary widely across clinics. In routine IVF/ICSI practice, gonadotropin selection, starting doses, dose adjustments, and the balance of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) bioactivity are highly individualized, yet real-world U.S. data describing starting doses and FSH:LH ratios have not previously been published.
METHODS: This retrospective observational study analyzed IVF/ICSI cycles recorded between 2010 and 2024 in Cercle, the largest fertility electronic medical records database in the U.S., comprising 42 fertility clinics. Baseline patient characteristics and ovarian stimulation practices were assessed descriptively, including protocol type, starting doses, and dose adjustments.
RESULTS: A total of 198,782 cycles from 128,166 patients were included; 74% utilized ICSI. Median patient age was 36 years and 60% were White. The most common infertility diagnoses were male factor infertility (20%) and diminished ovarian reserve (17%). Median body mass index was 25, with 22% ≥30. Median anti-Müllerian hormone was 2.21 ng/mL. GnRH antagonist protocols were used in 77% of cycles. Mixed gonadotropin protocols combining highly purified human menopausal gonadotropin (HP-hMG, with a 1:1 FSH:LH bioactivity ratio) and recombinant FSH (rFSH) accounted for 88% of cycles, compared with rFSH monotherapy (8%) and HP-hMG monotherapy (4%). Among cycles initiating both agents on stimulation day 1, most common starting doses were 300 IU rFSH and 150 IU HP-hMG. Dose adjustments were more frequent for rFSH (58%) than for HP-hMG (53%).
CONCLUSIONS: U.S. IVF/ICSI practice is dominated by mixed HP-hMG and rFSH protocols, with the most common total FSH:LH bioactivity ratio of approximately 3:1. This analysis provides the first large-scale characterization of gonadotropin starting doses and FSH:LH ratios in U.S. clinical practice and offers evidence to support more standardized and efficient ovarian stimulation strategies in the future.
METHODS: This retrospective observational study analyzed IVF/ICSI cycles recorded between 2010 and 2024 in Cercle, the largest fertility electronic medical records database in the U.S., comprising 42 fertility clinics. Baseline patient characteristics and ovarian stimulation practices were assessed descriptively, including protocol type, starting doses, and dose adjustments.
RESULTS: A total of 198,782 cycles from 128,166 patients were included; 74% utilized ICSI. Median patient age was 36 years and 60% were White. The most common infertility diagnoses were male factor infertility (20%) and diminished ovarian reserve (17%). Median body mass index was 25, with 22% ≥30. Median anti-Müllerian hormone was 2.21 ng/mL. GnRH antagonist protocols were used in 77% of cycles. Mixed gonadotropin protocols combining highly purified human menopausal gonadotropin (HP-hMG, with a 1:1 FSH:LH bioactivity ratio) and recombinant FSH (rFSH) accounted for 88% of cycles, compared with rFSH monotherapy (8%) and HP-hMG monotherapy (4%). Among cycles initiating both agents on stimulation day 1, most common starting doses were 300 IU rFSH and 150 IU HP-hMG. Dose adjustments were more frequent for rFSH (58%) than for HP-hMG (53%).
CONCLUSIONS: U.S. IVF/ICSI practice is dominated by mixed HP-hMG and rFSH protocols, with the most common total FSH:LH bioactivity ratio of approximately 3:1. This analysis provides the first large-scale characterization of gonadotropin starting doses and FSH:LH ratios in U.S. clinical practice and offers evidence to support more standardized and efficient ovarian stimulation strategies in the future.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HSD44
Topic
Health Service Delivery & Process of Care
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Reproductive & Sexual Health