UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056760 |
|---|---|
| Receipt number | R000064874 |
| Scientific Title | 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) |
| Date of disclosure of the study information | 2025/01/20 |
| Last modified on | 2026/04/28 15:57:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A real-world retrospective study comparing two ovarian stimulation drugs (follitropin delta and follitropin alpha) in Japanese IVF practice
Acronym
FALCON Study (Follitropin ALfa vs delta CONparison)
Scientific Title
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)
Scientific Title:Acronym
FALCON Study
Region
| Japan |
Condition
Condition
Infertility (cases with indication for in-vitro fertilization and embryo transfer)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Follitropin delta is a novel recombinant FSH derived from a human cell line, characterized by an individualized dosing algorithm based on serum anti-Mullerian hormone and body weight. While its non-inferiority to Follitropin alfa has been demonstrated in large-scale RCTs, real-world comparative data in Japanese clinical practice remain limited. This study aims to compare the clinical effectiveness and safety of Follitropin alfa and Follitropin delta using single-center retrospective cohort data, with patient background balanced through propensity score matching.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 43 | years-old | > |
Gender
Female
Key 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
Key exclusion criteria
Non-IVF stimulation purposes (e.g., in-vitro maturation)
Natural cycles without exogenous stimulation
Cycles with missing critical baseline covariate (age)
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Komiya |
Organization
HORAC Grand Front Osaka Clinic
Division name
Gynecology
Zip code
530-0011
Address
Grand Front Osaka Tower B 15F, 3-1, Ofuka-cho, Kita-ku, Osaka city, Osaka, Japan
TEL
0663778824
komiya520@ivfjapan.com
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Komiya |
Organization
HORAC Grand Front Osaka Clinic
Division name
Gynecology
Zip code
530-0011
Address
Grand Front Osaka Tower B 15F, 3-1, Ofuka-cho, Kita-ku, Osaka city, Osaka, Japan
TEL
0663778824
Homepage URL
komiya520@ivfjapan.com
Sponsor or person
Institute
HORAC Grand Front Osaka Clinic
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
HORAC Grand Front Osaka Clinic
Address
Grand Frront Osaka Tower B 15F, 3-1, Ofuka-cho, Kita-ku, Osaka city, Osaka, Japan
Tel
0663778824
komiya520@ivfjapan.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
300
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 01 | Month | 20 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064874
