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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031139
Receipt No. R000035572
Official scientific title of the study Outcome of laparoscopy before ICSI in patients with unexplained infertility in a tertiary care hospital in Egypt
Date of disclosure of the study information 2018/07/01
Last modified on 2018/02/05

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Basic information
Official scientific title of the study Outcome of laparoscopy before ICSI in patients with unexplained infertility in a tertiary care hospital in Egypt
Title of the study (Brief title) Outcome of laparoscopy in unexplained infertility
Region
Africa

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

Objectives
Narrative objectives1 testing role of laparoscopy before ICSI or has no role
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Cumulative pregnancy rate
Key secondary outcomes Complications
Acceptability
Affordability

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
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 Device,equipment
Interventions/Control_1 Laparoscopy then ICSI
Interventions/Control_2 ICSI without laparoscopy
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
25 years-old <=
Age-upper limit
35 years-old >=
Gender Female
Key inclusion criteria Unexplained infertility for more than 1 year
Age < 35 years old
Normal BMI
Key exclusion criteria Other causes of infertility
Age > 35 years old
Patients unfit for laparoscopy
Patients refusing participation
Target sample size 400

Research contact person
Name of lead principal investigator Ayman Shehata Dawood
Organization Tanta university
Division name Ayman shehata dawood
Address Tanta university
TEL +201020972067
Email ayman.dawood@med.tanta.edu.eg

Public contact
Name of contact person Ayman shehata dawood
Organization Tanta university
Division name Ayman Shehata Dawood
Address Tanta university
TEL +201020972067
Homepage URL
Email ayman.dawood@med.tanta.edu.eg

Sponsor
Institute Tanta University
Institute
Department

Funding Source
Organization Tanta University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs YES
Study ID_1 Adel Elgergawy
Org. issuing International ID_1 Tanta University
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 07 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 01 Month 01 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 02 Month 05 Day
Last modified on
2018 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035572

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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