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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021983
Receipt No. 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

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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
Obsterics 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
Email 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/
Email metsugi@iuhw.ac.jp

Sponsor
Institute Sanno Hospital
Institute
Department

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
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 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
URL(English) https://upload.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
Registered date File name


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