UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008760 |
|---|---|
| Receipt number | 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 20:22:58 |
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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
| Obstetrics 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
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
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
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
hooishi-tky@umin.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo
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
Name of secondary funder(s)
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010290
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