UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013956 |
|---|---|
| Receipt number | R000016246 |
| Scientific Title | A prospective randomized study for improving the ovarian reserve by administration of granulocyte colony-stimulating factor (G-CSF). |
| Date of disclosure of the study information | 2014/05/14 |
| Last modified on | 2019/04/15 18:09:28 |
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Basic information
Public title
A prospective randomized study for improving the ovarian reserve by administration of granulocyte colony-stimulating factor (G-CSF).
Acronym
A study for improving the ovarian reserve with G-CSF.
Scientific Title
A prospective randomized study for improving the ovarian reserve by administration of granulocyte colony-stimulating factor (G-CSF).
Scientific Title:Acronym
A study for improving the ovarian reserve with G-CSF.
Region
| Japan |
Condition
Condition
Infertility treated by assisted reproductive technology.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether administration of Granulocyte colony-stimulating factor (G-CSF) increases the ovarian reserve, resulting in an improvement of outcomes of assisted reproductive technology (ART) after 2 months from G-CSF administration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of pregnancy
Key secondary outcomes
Follicular development, the numbers of retrieved oocytes, fertilized oocytes, and embryos, and hormones inculuding anti-Mullerian hormone (AMH)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
ART patients who meet inclusion criteria and do not meet exclusion criteria are prospectively allocated at random into two groups as follows; the control group who undergoes ART therapy without administration of G-CSF, and the G-CSF group who undergoes ART therapy after two months from administrations of G-CSF. And the outcomes of ART are compared between two groups.
The G-CSF group undergoes ART therapy, following subcutaneous administrations of 100 micro-g G-CSF (Neutrogin, Chyuugai Pharmacy) after 1 to 3 days from ovulation in 1 to 2 cycles. The effects on the ovarian reserve are assessed by repeated measurements of AMH, FSH, LH and E2 on the day 3 of menstrual cycle before and after G-CSF administration.
Patients can freely decide to participate in the trial or not, and do not have any disadvantages when they do not participate. Informed consents are obtained from all participants after they have received appropriate explanations about implications, purposes, methods, expected benefits, and possible risks of G-CSF administration, and the protection of privacy.
Interventions/Control_2
The control group undergoes ART therapy without administration of G-CSF. We measure AMH on two separate days, confirming no change in AMH.
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
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
The study include patients who satisfy all the following criteria; (1) age = or < 42 years, (2) to undergo the first or second attempt of ART therapy, (3) AMH < 2 ng/mL, and (4) day-3-FSH < 30 IU/mL.
Key exclusion criteria
Patients are excluded when they meet any of the following criteria; (1) to have a drug allergy or a dangerous allergic disease, (2) to have severe hepatic, renal, and/or heart diseases, and (3) to have the uterine infertility.
Target sample size
226
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Jinno |
Organization
Women's Clinic Jinno
Division name
Department of Gynecology
Zip code
Address
3-1-39-201 Kokuryou-chou, Choufu City, Tokyo, Japan
TEL
042-480-3105
mjinno@s9.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Jinno |
Organization
Women's Clinic Jinno
Division name
Department of Gynecology
Zip code
Address
3-1-39-201 Kokuryou-chou, Choufu City, Tokyo, Japan
TEL
042-480-3105
Homepage URL
mjinno@s9.dion.ne.jp
Sponsor or person
Institute
Women's Clinic Jinno
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
Inagi Municipal Hospital, Department of Obstetrics and Gynecology
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
ウィメンズクリニック神野（東京都）/ Women's Clinic Jinno (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 14 | 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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 14 | Day |
Last modified on
| 2019 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016246
