UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061203 |
|---|---|
| Receipt number | R000070029 |
| Scientific Title | Follitropin Beta as a Rescue Protocol for Poor Responders to Follitropin Delta: A Retrospective Within-Patient Analysis of Ovarian Stimulation Outcomes |
| Date of disclosure of the study information | 2026/04/08 |
| Last modified on | 2026/04/09 17:10:07 |
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Basic information
Public title
Follitropin Beta vs Follitropin Delta for Poor Responders to Rekovelle: A Preliminary Comparison
Acronym
BELTA
Scientific Title
Follitropin Beta as a Rescue Protocol for Poor Responders to Follitropin Delta: A Retrospective Within-Patient Analysis of Ovarian Stimulation Outcomes
Scientific Title:Acronym
BELTA
Region
| Japan |
Condition
Condition
infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether switching from follitropin delta to follitropin beta improves the number of oocytes retrieved and the number of blastocysts obtained in cases that showed a poor response to ovarian stimulation with follitropin delta.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of oocytes retrieved per cycle (comparison between follitropin delta and follitropin beta cycles within the same patient)
Key secondary outcomes
Number of metaphase II (MII) oocytes retrieved
Number of cryopreserved blastocysts
Number of good-quality cryopreserved blastocysts
Blastulation rate
Good-quality blastulation rate
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Female patients who underwent in vitro fertilization and embryo transfer at our clinic
Having undergone at least one ovarian stimulation cycle using follitropin delta (Rekovelle) with an antagonist protocol
Having undergone at least one subsequent cycle switched to follitropin beta (Follitropin) with an antagonist protocol due to poor response to follitropin delta
Oocyte retrieval date between January 1, 2025 and March 31, 2026
Key exclusion criteria
Cycles in which other gonadotropin preparations were added during follitropin delta stimulation
Cycles using stimulation protocols other than the antagonist protocol (e.g., PPOS)
Patients with a history of ovarian surgery that may have affected ovarian reserve
Cycles in which the stimulation protocol was modified for OHSS prevention
Cycles with missing data precluding analysis of the primary outcome
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Kuroda |
Organization
Haruki Ladies Clinic
Division name
Gynecology
Zip code
542-0081
Address
Quartz Shinsaibashi 7F, 3-12-14, Minami-Semba, Chuo-ku, Osaka, Japan
TEL
06-6281-8801
kuroda@haruki-cl.com
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Kuroda |
Organization
Haruki Ladies Clinic
Division name
Gynecology
Zip code
542-0081
Address
Quartz Shinsaibashi 7F, 3-12-14, Minami-Semba, Chuo-ku, Osaka, Japan
TEL
06-6281-8801
Homepage URL
kuroda@haruki-cl.com
Sponsor or person
Institute
Haruki Ladies Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Haruki Ladies Clinic
Address
Quartz Shinsaibashi 7F, 3-12-14, Minami-Semba, Chuo-ku, Osaka, Japan
Tel
06-6281-8801
tomita@haruki-cl.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
| 2026 | Year | 04 | Month | 08 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 04 | Month | 08 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070029
