UMIN-CTR Clinical Trial

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	Obsterics 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
Last 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
Email	mjinno@s9.dion.ne.jp

Public contact
1st 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
Email	mjinno@s9.dion.ne.jp

Sponsor
Institute	Women's Clinic Jinno
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016246