UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021983 |
|---|---|
| Receipt number | R000021713 |
| Scientific Title | Standard dose of effervescent progesterone vaginal tablet for luteal phase support in frozen embryo transfer cycle |
| Date of disclosure of the study information | 2016/04/19 |
| Last modified on | 2016/11/20 16:26:57 |
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Basic information
Public title
Standard dose of effervescent progesterone vaginal tablet for luteal phase support in frozen embryo transfer cycle
Acronym
SHIFT study
Scientific Title
Standard dose of effervescent progesterone vaginal tablet for luteal phase support in frozen embryo transfer cycle
Scientific Title:Acronym
SHIFT study
Region
| Japan |
Condition
Condition
infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the efficacy and safety of luteal support by Lutinus (Endometrin) vaginal tablet on ongoing pregnancy rate in Japanese patients undergoing frozen embryo transfer in real clinical settings.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
ongoing pregnancy rate (six weeks after administration of the drug)
Key secondary outcomes
1) hCG positive rate
2) clinical pregnancy rate
3) safety information
4) withdrawal rate
5) relationship between ongoing pregnancy rate and age or serum progesterone level
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patients who have given written informed consent to participate in this study
2) Patients who underwent IVF-ICSI to obtain autologous frozen embryo
3) Patients who will undergo the frozen embryo transfer in artificial cycles.
Key exclusion criteria
Patients who had a history of oversensitivity, abnormal uterine bleeding of undetermined origin, missed abortion, ectopic pregnancy, severe hepatic disorder, breast cancer, genital cancer and porphyria, and are under breast-feeding.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TOSHIHIRO FUJIWARA |
Organization
Sanno Hospital
Division name
Center for Human Reproduction and Gynecologic Endoscopy
Zip code
Address
8-10-16 Akasaka, Minato-ku, Tokyo 107-0052 JAPAN
TEL
03-3402-3151
fujiwat@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TOSHIHIRO FUJIWARA |
Organization
Sanno Hospital
Division name
Center for Human Reproduction and Gynecologic Endoscopy
Zip code
Address
8-10-16 Akasaka, Minato-ku, Tokyo 107-0052 JAPAN
TEL
03-3402-3151
Homepage URL
http://www.sannoclc.or.jp/hospital/
metsugi@iuhw.ac.jp
Sponsor or person
Institute
Sanno Hospital
Institute
Department
Personal name
Funding Source
Organization
Ferring Pharmaceuticals
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
LDS Ltd.
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
山王病院（東京都）
高木病院（福岡県）
福岡山王病院（福岡県）
国際医療福祉大学病院（栃木県）
セントマザー産婦人科（福岡県）
セントルカ産婦人科（大分県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
under subjects enrolling
Management information
Registered date
| 2016 | Year | 04 | Month | 19 | Day |
Last modified on
| 2016 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021713
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
