UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056687 |
|---|---|
| Receipt number | R000064796 |
| Scientific Title | The Effect of Letrozole Cotreatment on Poor Responses in Ovarian Stimulation with Follitropin Delta: A Strategy for 'High AMH but Poor Response' |
| Date of disclosure of the study information | 2025/01/10 |
| Last modified on | 2025/03/13 15:10:24 |
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Basic information
Public title
The Effect of Letrozole Cotreatment on Poor Responses in Ovarian Stimulation with Follitropin Delta: A Strategy for 'High AMH but Poor Response'
Acronym
A Strategy for 'High AMH but Poor Response'
Scientific Title
The Effect of Letrozole Cotreatment on Poor Responses in Ovarian Stimulation with Follitropin Delta: A Strategy for 'High AMH but Poor Response'
Scientific Title:Acronym
DeltAI study 1
Region
| Japan |
Condition
Condition
infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates whether cotreatment with letrozole reduces unexpected poor responses in controlled ovarian stimulation using follitropin delta.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The poor response rate of the number of oocytes retrieved
Key secondary outcomes
The total dosage of follitropin dela and the duration of administration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
2.5 mg of letrozole was orally administered daily for 5 days starting from the day follitropin delta was administered.
Interventions/Control_2
Follitropin delta alone
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
| 18 | years-old | <= |
Age-upper limit
| 43 | years-old | >= |
Gender
Female
Key inclusion criteria
The controlled ovarian stimulation cycles for IVF/ICSI using follitropin delta performed at Haruki Ladies Clinic in Japan from October 2021 to March 2023.
Key exclusion criteria
(1) the presence of ovarian cysts that made oocyte puncture difficult, (2) initiation of injections outside of days 2-4 of the menstrual cycle, and (3) presence of uterine fibroids (myoma uteri) that interfered with oocyte puncture.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Kuroda |
Organization
Haruki Ladies Clinic
Division name
The medical office
Zip code
542-0081
Address
7th floor, ZENT Shinsaibashi, 4-3-2 Minami-semba, Chuo-ku, Osaka-city, Osaka-prefecture, 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
The medical office
Zip code
542-0081
Address
7th floor, ZENT Shinsaibashi, 4-3-2 Minami-semba, Chuo-ku, Osaka-city, Osaka-prefecture, Japan
TEL
06-6281-8801
Homepage URL
kuroda@haruki-cl.com
Sponsor or person
Institute
Haruki Ladies Clinic
Institute
Department
Personal name
Hiromasa Kuroda
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
The ethics review board of Haruki Ladies Clinic
Address
7th floor, ZENT Shinsaibashi, 4-3-2 Minami-semba, Chuo-ku, Osaka-city, Osaka-prefecture, Japan
Tel
06-6281-8801
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
春木レディースクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.7759/cureus.78513
Number of participants that the trial has enrolled
153
Results
The poor response was less frequent in the cotreatment group: one of 36 cycles (2.8%) in the cotreatment group and nine of 49 cycles (18.4%) in the follitropin delta alone group (p < 0.05).
Results date posted
| 2025 | Year | 02 | Month | 06 | Day |
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 10 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064796
