UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056760 |
|---|---|
| Receipt number | R000064874 |
| Scientific Title | A Retrospective Cohort Study to Identify Patient Characteristics and Treatment-Related Factors Associated with Variability in Oocyte Yield During Controlled Ovarian Stimulation with Follitropin Delta (Rekovelle) in Assisted Reproductive Technology |
| Date of disclosure of the study information | 2025/01/20 |
| Last modified on | 2025/01/20 16:38:42 |
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Basic information
Public title
Analysis of Factors Associated with Oocyte Yield Variability in IVF Patients Treated with Follitropin Delta (Rekovelle)
Acronym
ROVAL Study
(Rekovelle Oocyte Yield VAriability anaLysis Study)
Scientific Title
A Retrospective Cohort Study to Identify Patient Characteristics and Treatment-Related Factors Associated with Variability in Oocyte Yield During Controlled Ovarian Stimulation with Follitropin Delta (Rekovelle) in Assisted Reproductive Technology
Scientific Title:Acronym
RECOVER Study
(REkovelle Controlled Ovarian stimulation Variability Evaluation Retrospective Study)
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify factors associated with variability in oocyte yield during controlled ovarian stimulation with follitropin delta (Rekovelle) in assisted reproductive technology. This study specifically aims to determine the relationship between patient characteristics (age, AMH levels, BMI, etc.) and treatment-related factors (dosage, stimulation protocol, etc.) with variations in oocyte yield, to establish more predictable ovarian stimulation protocols.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of retrieved oocytes
Specific evaluation points:
Association between patient characteristics/treatment-related factors and the number of retrieved oocytes
Comparison of characteristics between high-variability and low-variability groups based on the coefficient of variation (CV) in oocyte yield
Key secondary 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
| 20 | years-old | <= |
Age-upper limit
| 43 | years-old | > |
Gender
Female
Key inclusion criteria
Patients who underwent IVF/ICSI with controlled ovarian stimulation using Rekovelle at our institution
Age 20-43 years
Patients who received treatment during the study period (from Apr 2022 to Des 2024)
Key exclusion criteria
Poor responders according to the Bologna criteria
Severe endometriosis (r-ASRM classification Stage IV)
Severe male factor infertility (severe oligozoospermia based on WHO criteria)
Cases deemed inappropriate for the study by the principal investigator for medical reasons
Target sample size
300
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
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064874
