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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032997
Receipt No. 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

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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
Obsterics 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
Email 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
Email reiko.shiba0703@gmail.com

Sponsor
Institute Kinutani Womens Clinic
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037597

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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