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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032841
Receipt No. R000037453
Scientific Title Booster HCG dose for unruptured follicles in normally stimulated cycles
Date of disclosure of the study information 2018/12/31
Last modified on 2019/06/02

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Basic information
Public title Booster HCG dose for unruptured follicles in normally stimulated cycles
Acronym Booster HCG for unruptured follicles
Scientific Title Booster HCG dose for unruptured follicles in normally stimulated cycles
Scientific Title:Acronym Booster HCG for unruptured follicles
Region
Africa

Condition
Condition Nor recruiting
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Pregnancy rate after booster dose HCG in unruptured follicles
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Pregnancy rates
Key secondary outcomes OHSS

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 HCG booster dose (10,000IU)given IM for patients with unruptured MGF after 48 hours follow up of the previous dose.
Interventions/Control_2 Placebo saline 2 ml given IM for patients with unruptured MGF after 48 hours follow up of the previous dose.
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
20 years-old <=
Age-upper limit
40 years-old >=
Gender Female
Key inclusion criteria Patient suffering infertility whether primary or secondary with unruptured MGf after giving the ususal 10,000IU IM at the time of ovulation
Normally stimulated cycles
Normal other factors of infertility
Key exclusion criteria Other factors of infertility
IVF/ICSI cycles
Poor ovarian reserve


Target sample size 80

Research contact person
Name of lead principal investigator
1st name Ayman
Middle name Shehata
Last name Dawood
Organization Tanta University
Division name Ayman shehata dawood
Zip code 31111
Address Tanta, gharbia, Egypt
TEL +201020972067
Email ayman.dawood@med.tanta.edu.eg

Public contact
Name of contact person
1st name Ayman
Middle name Shehata
Last name Dawood
Organization Tanta university
Division name Ayman Shehata Dawood
Zip code 31111
Address Tanta, gharbia, Egypt
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 Tanta university
Address Tanta, gharbia, Egypt
Tel +201020972067
Email ayman.dawood@med.tanta.edu.eg

Secondary IDs
Secondary IDs YES
Study ID_1 Adel Elgergawy
Org. issuing International ID_1 Tanta University
Study ID_2 Ahmed Elhalwagy
Org. issuing International ID_2 Tanta University
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 31 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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2018 Year 12 Month 01 Day
Date of closure to data entry
2018 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 01 Day
Last modified on
2019 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037453

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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