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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027193
Receipt No. R000031161
Scientific Title Reduction of cetrorelix dose in the antagonist multiple dose protocol and its impact on pregnancy rate and economic aspect. A randomized controlled study
Date of disclosure of the study information 2017/09/01
Last modified on 2017/08/15

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Basic information
Public title Reduction of cetrorelix dose in the antagonist multiple dose protocol and its impact on pregnancy rate and economic aspect. A randomized controlled study
Acronym Reduction of cetrorelix dose and its impact on the pregnancy rate and economic aspects
Scientific Title Reduction of cetrorelix dose in the antagonist multiple dose protocol and its impact on pregnancy rate and economic aspect. A randomized controlled study
Scientific Title:Acronym Reduction of cetrorelix dose and its impact on the pregnancy rate and economic aspects
Region
Africa

Condition
Condition recruitong
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effectivness of reduced cetrorelix dose in antagonist protocols on pregnancy rate and economic aspects
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of ova retreived, quality of ooocytes
Key secondary outcomes Number of embryos , clinical and ongoing pregnancy rates, and economic aspects of reducing cetrorelix dose.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients will receive 0.25 mg Cetrorelix in the pituitary down regulation through the period from the ovum reached 14 mm and till triggering day
Interventions/Control_2 Patients will receive 0.125 mg cetrorelix in the pituitary down regulation period from the ovum reches 14 mm and till triggering day
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
23 years-old <=
Age-upper limit
32 years-old >=
Gender Female
Key inclusion criteria women undergoing IVF/ICSI under 35 years old
antagonist protocol
PCO
AMH > 1mIU
Key exclusion criteria Severe endometriosis
Previous IVF/ICSI failure
Severe male factor
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayman Shehata Dawood
Organization Tanta university
Division name Obstetrics and gynecology
Zip code
Address Tanta university
TEL +201020972067
Email ayman.dawood@med.tanta.edu.eg

Public contact
Name of contact person
1st name
Middle name
Last name Ayman shehata dawood
Organization Tanta university
Division name Obstetrics and gynecology
Zip code
Address Tanta university
TEL +201020972067
Homepage URL
Email ayman.dawood@med.tanta.edu.eg

Sponsor
Institute Tanta university
Obstetrics and gynecology department
Institute
Department

Funding Source
Organization Tanta University
Obstetrics and gynecology department
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
2017 Year 09 Month 01 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
2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 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
2017 Year 04 Month 29 Day
Last modified on
2017 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031161

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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