UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029446 |
|---|---|
| Receipt number | R000033642 |
| Scientific Title | A prospective study comparing the effect of recombinant human chorionic gonadtropin (r-hCG) versus urine-derived hCG (u-hCG) on oocyte maturation, embryo development, and pregnancy outcome in assisted reproductive technology (ART) cycles |
| Date of disclosure of the study information | 2017/10/06 |
| Last modified on | 2019/12/22 12:01:46 |
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Basic information
Public title
A prospective study comparing the effect of recombinant human chorionic gonadtropin (r-hCG) versus urine-derived hCG (u-hCG) on oocyte maturation, embryo development, and pregnancy outcome in assisted reproductive technology (ART) cycles
Acronym
Recombinant human chorionic gonadtropin (r-hCG) versus urine-derived hCG (u-hCG)
Scientific Title
A prospective study comparing the effect of recombinant human chorionic gonadtropin (r-hCG) versus urine-derived hCG (u-hCG) on oocyte maturation, embryo development, and pregnancy outcome in assisted reproductive technology (ART) cycles
Scientific Title:Acronym
Recombinant human chorionic gonadtropin (r-hCG) versus urine-derived hCG (u-hCG)
Region
| Japan |
Condition
Condition
Infertility and subfertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively compare the effect of recombinant human chorionic gonadtropin(r-hCG) versus urine-derived hCG (u-hCG) on oocyte maturation, embryo development, and pregnancy outcome in assisted reproductive technology (ART) cycles
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical pregnancy rate
Key secondary outcomes
Oocyte retrieval counts, mature oocyte rate, fertilization rate, and blastocyst rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
Recombinant human chorionic gonadtropin(r-hCG)250 microgram injection
Interventions/Control_2
Urine-derived hCG (u-hCG) 10000IU injection
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Infertile/subfertile women undergoing assisted reproductive technology (ART) cycles
Key exclusion criteria
Patients who have a history of allergy and adverse effects to the hCG agents
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Kitaya |
Organization
Reproduction Clinic Osaka
Division name
IVF Center
Zip code
5300011
Address
Grand Front Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL
0661363344
kitaya@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Kitaya |
Organization
Reproduction Clinic Osaka
Division name
IVF Center
Zip code
530-0011
Address
Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL
0661363344
Homepage URL
kitaya@koto.kpu-m.ac.jp
Sponsor or person
Institute
Reproduction Clinic Osaka
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Reproduction Clinic Osaka
Address
Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
Tel
0661363344
kitaya@koto.kpu-m.ac.jp
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
| 2017 | Year | 10 | Month | 06 | 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
| 2017 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 05 | Day |
Last modified on
| 2019 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033642
