UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027193 |
|---|---|
| Receipt number | 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 22:19:32 |
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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
| Obstetrics 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
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
ayman.dawood@med.tanta.edu.eg
Sponsor or person
Institute
Tanta university
Obstetrics and gynecology department
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031161
