UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032997 |
|---|---|
| Receipt number | R000037597 |
| Scientific Title | Exploratory test to investigate the clinical pregnancy rate between four vaginal progesterones:Lutinus vaginal tablet(300 mg/day), Utrogestan Vaginal Capsule(600 mg/day), Luteum Vaginal Suppository(800 mg/day), Crinone vaginal gel (90 mg/day) |
| Date of disclosure of the study information | 2018/06/14 |
| Last modified on | 2019/03/03 17:33:44 |
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Basic information
Public title
Exploratory test to investigate the clinical pregnancy rate between four vaginal progesterones:Lutinus vaginal tablet(300 mg/day), Utrogestan Vaginal Capsule(600 mg/day), Luteum Vaginal Suppository(800 mg/day), Crinone vaginal gel (90 mg/day)
Acronym
EXCULL-STUDY
Scientific Title
Exploratory test to investigate the clinical pregnancy rate between four vaginal progesterones:Lutinus vaginal tablet(300 mg/day), Utrogestan Vaginal Capsule(600 mg/day), Luteum Vaginal Suppository(800 mg/day), Crinone vaginal gel (90 mg/day)
Scientific Title:Acronym
EXCULL-STUDY
Region
| Japan |
Condition
Condition
infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of four vaginal progesterones as luteal phase support (LPS) in Frozen-thawed Embryo Transfer (Frozen-ET) cycles, including Lutinus, Utrogestan, Luteum, Crinone.
Basic objectives2
Others
Basic objectives -Others
To assess the relationship between serum progesteon level and clinical pregnancy rate of four vaginal progesterones
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical pregnancy rate (CPR), Fetal heartbeat positive rate(FHR) and miscarriage rate (MR).
Key secondary outcomes
serum progesterone
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
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lutinus (3 doses of 100 mg per day)
Interventions/Control_2
Utrogestan (3 doses of 200 mg per day)
Interventions/Control_3
Luteum (2 doses of 400 mg per day)
Interventions/Control_4
Onecrinone (1 dose of 90 mg per day)
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1) Patients who will undergo the frozen embryo transfer in hormone replacement therapy cycles.
2) Patients who have given written informed consent to participate in this study
Key exclusion criteria
Patients related to the contraindication items described in the drug package
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | REIKO SHIBA |
Organization
Kinutani Womens Clinic
Division name
doctor department
Zip code
Address
4F 8-23 Hondori, Naka-ku, Hiroshima-city, Hiroshima-Prefecture
TEL
082-247-6399
reiko.shiba0703@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | REIKO SHIBA |
Organization
Kinutani Womens Clinic
Division name
Doctor department
Zip code
Address
4F 8-23 Hondori, Naka-ku, Hiroshima-city, Hiroshima-Prefecture
TEL
082-247-6399
Homepage URL
reiko.shiba0703@gmail.com
Sponsor or person
Institute
Kinutani Womens Clinic
Institute
Department
Personal name
Funding Source
Organization
Kinutani Womens 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
| 2018 | Year | 06 | Month | 14 | 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
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | 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
| 2018 | Year | 06 | Month | 14 | Day |
Last modified on
| 2019 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037597
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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