UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031139 |
|---|---|
| Receipt number | R000035572 |
| Scientific Title | 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 | 2021/08/09 21:02:45 |
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Basic information
Public title
Outcome of laparoscopy before ICSI in patients with unexplained infertility in a tertiary care hospital in Egypt
Acronym
Outcome of laparoscopy in unexplained infertility
Scientific Title
Outcome of laparoscopy before ICSI in patients with unexplained infertility in a tertiary care hospital in Egypt
Scientific Title:Acronym
Outcome of laparoscopy in unexplained infertility
Region
| Africa |
Condition
Condition
recruiting
Classification by specialty
| Obstetrics 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
| 1st name | Ayman |
| Middle name | Shehata |
| Last name | Dawood |
Organization
Tanta university
Division name
Ayman shehata dawood
Zip code
31111
Address
Tanta university
TEL
+201020972067
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 university
TEL
+201020972067
Homepage URL
ayman.dawood@med.tanta.edu.eg
Sponsor or person
Institute
Tanta University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Tanta University
Address
Elgeish st., Tanta, Egypt
Tel
+201020972067
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
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
62
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
STUDY ID STILL RECRUITING
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
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 05 | Day |
Last modified on
| 2021 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035572
