UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052346 |
|---|---|
| Receipt number | R000059761 |
| Scientific Title | Prospective Evaluation of Oocyte Yield After Granulocyte Colony-Stimulating Factor Priming in Women with Severe Diminished Ovarian Reserve: A Non-Randomized Clinical Investigation |
| Date of disclosure of the study information | 2023/09/28 |
| Last modified on | 2025/01/20 16:40:25 |
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Basic information
Public title
A Prospective, Non-Randomized Clinical Study on the Efficacy of Oocyte Retrieval Following G-CSF Priming in Cases with Severe Ovarian Reserve Insufficiency
Acronym
G-ORES (G-CSF Oocyte Retrieval Efficacy Study)
Scientific Title
Prospective Evaluation of Oocyte Yield After Granulocyte Colony-Stimulating Factor Priming in Women with Severe Diminished Ovarian Reserve: A Non-Randomized Clinical Investigation
Scientific Title:Acronym
PEORY-G (Prospective Evaluation of Oocyte Retrieval Yield with G-CSF)
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the impact of Granulocyte Colony-Stimulating Factor (G-CSF) on the success rate of oocyte retrieval in women diagnosed with Diminished Ovarian Reserve (DOR).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oocyte retrieval success rate in the subsequent cycle following G-CSF priming.
Key secondary outcomes
Cumulative oocyte retrieval success rate up to six months post-G-CSF treatment.
Cumulative pregnancy rate up to six months post-G-CSF treatment.
Follicular growth metrics observed after G-CSF priming.
Changes in Anti-Mullerian Hormone (AMH) levels post-G-CSF treatment.
Time duration from G-CSF injection to successful oocyte retrieval within six months post-treatment.
Time duration from G-CSF injection to clinical pregnancy confirmation within six months post-treatment.
Incidence of adverse events observed post-G-CSF administration.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Initiate the oocyte retrieval cycle following subcutaneous administration of 300ug of G-CSF (Filgrastim BS Injection 300ug Syringe F) during the early luteal phase.
Interventions/Control_2
Initiate the oocyte retrieval cycle without the use of G-CSF.
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Participants must be aged 20 years or older.
Participants must have a history of at least one cancelled oocyte retrieval cycle due to lack of follicular development.
Participants must be diagnosed with Diminished Ovarian Reserve (DOR) by a qualified physician.
Participants must have no prior history of pregnancy.
Participants must not have any other underlying medical conditions.
Participants must provide written informed consent, acknowledging an understanding of the study's objectives and procedures.
Key exclusion criteria
Participants experiencing mental instability or other factors that would make participation in the study difficult are excluded.
Target sample size
220
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 Frront Osaka Tower B 15F, 3-1, Ofuka-cho, Kita-ku, Osaka city, Osaka, Japan
TEL
0636778824
komiya0703@gmail.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 Frront Osaka Tower B 15F, 3-1, Ofuka-cho, Kita-ku, Osaka city, Osaka, Japan
TEL
0636778824
Homepage URL
komiya0703@gmail.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
0636778824
komiya0703@gmail.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
| 2023 | Year | 09 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | 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
Management information
Registered date
| 2023 | Year | 09 | Month | 28 | 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=R000059761
