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Recruitment status Terminated
Unique ID issued by UMIN UMIN000008760
Receipt No. R000010290
Scientific Title Comparison between clomiphene citrate plus hMG or hMG alone, combined with flexible multi dose GnRH antagonist for patients with poor prognosis in IVF-ET programs
Date of disclosure of the study information 2012/08/24
Last modified on 2014/08/25

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Basic information
Public title Comparison between clomiphene citrate plus hMG or hMG alone, combined with flexible multi dose GnRH antagonist for patients with poor prognosis in IVF-ET programs
Acronym Clomiphene citrate plus HMG or hMG alone combined with flexible multi dose GnRH antagonist for patients with poor prognosis in IVF-ET programs
Scientific Title Comparison between clomiphene citrate plus hMG or hMG alone, combined with flexible multi dose GnRH antagonist for patients with poor prognosis in IVF-ET programs
Scientific Title:Acronym Clomiphene citrate plus HMG or hMG alone combined with flexible multi dose GnRH antagonist for patients with poor prognosis in IVF-ET programs
Region
Japan

Condition
Condition Infertile patient and poor responder in controlled ovarian hyperstimulation
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Compare the pregnancy rate of Clomid-hMG-GnRH antagonist regimen with hMG-GnRH antagonist protocol.
Demonstrate non-inferiority of Clomid regimen.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Evaluate the clinical pregnancy rate per ovarian stimulation, oocyte retrieval, and embryo transfer.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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 hMG-GnRH antagonist: start HMG(FSH:LH 1:1) from day3 until the day of hCG administration. Concomitant treatment with Ganirelix 0.25mg s.c. in multiple, flexible method when leading follicle reaches 14-15mm. HCG 10000IU when leading follicle reaches 18-20mm.
Interventions/Control_2 CC-hMG-GnRH antagonist: Clomiphen citrate 100mg/d from day 3 to 7. Start HMG 300IU/d daily from day 8.
Concomitant treatment with GnRH antagonist as above.
HCG administration is the same as above.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria 1) require IVF-ET for infertility treatment
2) less than four-times-history of controlled ovarian hyper stimulation with GnRH antagonist
3) Exhibit ovarian dysfunction by the findings such as
basal FSH above 10 mIU/ml, antral follicle count below 7, and oocyte retrieval below 5 in the previous cycle.
Key exclusion criteria 1) above 46 years of age
2) not allowed to be pregnant due to other medical complications
3) scheduled to undergo freezing of all embryos due to gynecological conditions such as myomas and adenomyosis.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihisa Fujimoto
Organization Department of Obstetrics and Gynecology
Faculty of Medicine, The University of Tokyo
Division name OBGYN, IVF center
Zip code
Address Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL 0338155411
Email fujimoto-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Oishi
Organization The University of Tokyo, Faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411(ext.33407)
Homepage URL
Email hooishi-tky@umin.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 24 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 Terminated
Date of protocol fixation
2011 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2013 Year 09 Month 01 Day
Date of closure to data entry
2013 Year 09 Month 01 Day
Date trial data considered complete
2013 Year 09 Month 01 Day
Date analysis concluded
2014 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 08 Month 23 Day
Last modified on
2014 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010290


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