UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061498 |
|---|---|
| Receipt number | R000070246 |
| Scientific Title | The effect of letrozole co-administration with follitropin delta on unexpected poor ovarian response and embryological/reproductive outcomes in high-AMH patients: a retrospective cohort study |
| Date of disclosure of the study information | 2026/05/08 |
| Last modified on | 2026/05/08 18:29:23 |
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Basic information
Public title
The effect of letrozole co-administration with follitropin delta on unexpected poor ovarian response and embryological/reproductive outcomes in high-AMH patients: a retrospective cohort study
Acronym
DeltAI 2 dtudy
Scientific Title
The effect of letrozole co-administration with follitropin delta on unexpected poor ovarian response and embryological/reproductive outcomes in high-AMH patients: a retrospective cohort study
Scientific Title:Acronym
DeltAI 2 dtudy
Region
| Japan |
Condition
Condition
infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Does letrozole co-administration with follitropin delta reduce poor ovarian response and improve embryological outcomes in high-AMH patients, and is basal FSH an independent predictor of poor ovarian response in this population?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of poor response
Key secondary outcomes
pregnancy outcomes
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
| 25 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
All patients who underwent follitropin delta GnRH antagonist stimulation cycles between November 2021 and April 2026
Key exclusion criteria
(i) oocyte retrieval was not performed due to complete ovulation prior to retrieval; (ii) transvaginal oocyte retrieval was not possible due to uterine fibroids causing inaccessibility of the ovary; or (iii) excessive oocyte retrieval with ovarian hyperstimulation requiring cycle cancellation. Patients with antiphospholipid syndrome or systemic lupus erythematosus were retained in the stimulation and embryological analyses but excluded from pregnancy outcome analyses
Target sample size
600
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
6F Quartz Shinsaibashi 3-12-14 Minamisenba, Chuo-ku, Osaka-shi Osaka 542-0081 Japan
TEL
0662818801
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
6F Quartz Shinsaibashi 3-12-14 Minamisenba, Chuo-ku, Osaka-shi Osaka 542-0081 Japan
TEL
0662818801
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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Haruki Ladies Clinic
Address
6F Quartz Shinsaibashi 3-12-14 Minamisenba, Chuo-ku, Osaka-shi Osaka 542-0081 Japan
Tel
0662818801
kuroda@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 | 05 | 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
1059
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 | 05 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This single-centre retrospective cohort study included follitropin delta gonadotrophin-releasing hormone (GnRH) antagonist cycles (excluding preimplantation genetic testing cycles) from 1,035 patients with AMH >3.5 ng/mL performed between November 2021 and April 2026. Letrozole was introduced sequentially over the study period; FD-alone cycles were concentrated in the early phase, letrozole 2.5 mg/day in the middle phase, and letrozole 5.0 mg/day in the later phase.
Management information
Registered date
| 2026 | Year | 05 | Month | 08 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070246
