UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015059 |
|---|---|
| Receipt number | R000017522 |
| Scientific Title | A Comparison of Different Hormone Replacement Regimens for Thawed Blastocyst Transfer in Patients with Infertility |
| Date of disclosure of the study information | 2014/09/05 |
| Last modified on | 2014/09/04 17:05:11 |
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Basic information
Public title
A Comparison of Different Hormone Replacement Regimens for Thawed Blastocyst Transfer in Patients with Infertility
Acronym
A Comparison of Different Hormone Replacement Regimens for Thawed Blastocyst Transfer in Patients with Infertility
Scientific Title
A Comparison of Different Hormone Replacement Regimens for Thawed Blastocyst Transfer in Patients with Infertility
Scientific Title:Acronym
A Comparison of Different Hormone Replacement Regimens for Thawed Blastocyst Transfer in Patients with Infertility
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Implantation rate and clinical pregnancy rate
Key secondary outcomes
Ongoing pregnancy rate
Base
Study type
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
Oral administration of Premarin (0.632mg per tablet, twice a day)
Interventions/Control_2
Embrocation of Estrogen patch (2.16mg per day in Estrogen conversion)
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Infertile patients.
Provided written informed consent.
Key exclusion criteria
The patient who corresponds to a contraindicated matter for each estrogen preparation.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sagiri Taguchi |
Organization
Oak Clinic
Division name
IVF Center
Zip code
Address
2-7-9 Tamade-nishi, Nishinari, Osaka, JAPAN
TEL
06-4398-1000
taguchi_s@oakclinic-group.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Nakamura |
Organization
Oak Clinic
Division name
IVF Center
Zip code
Address
2-7-9 Tamade-nishi, Nishinari, Osaka, JAPAN
TEL
06-4398-1000
Homepage URL
nakamura_y@oakclinic-group.com
Sponsor or person
Institute
Oak Clinic
Institute
Department
Personal name
Funding Source
Organization
Oak Clinic
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
| 2014 | Year | 09 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 04 | Day |
Last modified on
| 2014 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017522
