A real-world retrospective study comparing two ovarian stimulation drugs (follitropin delta and follitropin alpha) in Japanese IVF practice

Comparative effectiveness and safety of follitropin delta versus follitropin alpha in Japanese real-world ART practice: a propensity score-matched retrospective observational cohort study (FALCON study) - FALCON Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056760

Enrollment

4000

Registered

2025-01-20

Start date

2025-01-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility (cases with indication for in-vitro fertilization and embryo transfer)

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Cycles in which controlled ovarian stimulation with either Follitropin alfa or Follitropin delta was performed for in-vitro fertilization Cycles in which oocyte retrieval was performed Cycles treated at the participating institution within the study period

Exclusion criteria

Exclusion criteria: Non-IVF stimulation purposes (e.g., in-vitro maturation) Natural cycles without exogenous stimulation Cycles with missing critical baseline covariate (age)

Design outcomes

Primary

Measure	Time frame
Number of good-quality blastocysts per oocyte retrieval cycle (num_good_bl) Statistical model: Negative binomial regression with cluster-robust standard errors (clustered by patient) Effect measure: Rate ratio (RR) with 95% confidence interval Non-inferiority margin: lower bound of 95% CI for RR > 0.80	—

Secondary

Measure	Time frame
Number of oocytes retrieved Number of mature (M2) oocytes Number of fertilized embryos Number of good-quality cleavage-stage embryos Number of blastocysts Number of frozen embryos Clinical pregnancy rate per cycle (gestational sac confirmed at 5 weeks) Ongoing pregnancy rate per cycle (fetal heartbeat at 9 weeks) Live birth rate per cycle Incidence of moderate or severe ovarian hyperstimulation syndrome (OHSS, Golan grade 2) Incidence of severe OHSS (Golan grade 3) Rate of reaching embryo transfer	—

Measure

Time frame

Number of oocytes retrieved Number of mature (M2) oocytes Number of fertilized embryos Number of good-quality cleavage-stage embryos Number of blastocysts Number of frozen embryos Clinical pregnancy rate per cycle (gestational sac confirmed at 5 weeks) Ongoing pregnancy rate per cycle (fetal heartbeat at 9 weeks) Live birth rate per cycle Incidence of moderate or severe ovarian hyperstimulation syndrome (OHSS, Golan grade 2) Incidence of severe OHSS (Golan grade 3) Rate of reaching embryo transfer

—

Countries

Japan

Contacts

Public ContactShinnosuke Komiya

HORAC Grand Front Osaka Clinic Gynecology

komiya520@ivfjapan.com0663778824

Outcome results