Back to resultsHysterosalpingography and Hysteroscopy in ICSI
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
occlusion of tubes
non occlusion of tubes
Sponsored by
About this trial
This is an interventional other trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- women with infertility
Exclusion Criteria:
- women with medical disorders
Sites / Locations
- Aljazeera( Al Gazeera) hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
tubal occlusion
non occlusion of tube
Arm Description
occlusion of tubes
non occlusion of tubes
Outcomes
Primary Outcome Measures
the number of women who will become pregnant
number of women who will have positive pregnancy test
Secondary Outcome Measures
Full Information
NCT ID
NCT04778319
First Posted
February 27, 2021
Last Updated
February 27, 2021
Sponsor
Aljazeera Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04778319
Brief Title
Hysterosalpingography and Hysteroscopy in ICSI
Official Title
Hysterosalpingography and Hysteroscopy in Intracytoplasmic Sperm Injection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2021 (Anticipated)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
February 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aljazeera Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
unexplained infertility is a rising problem in clinical practice
Detailed Description
Assessment of uterine cavity is very important before ICSI
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tubal occlusion
Arm Type
Active Comparator
Arm Description
occlusion of tubes
Arm Title
non occlusion of tube
Arm Type
Sham Comparator
Arm Description
non occlusion of tubes
Intervention Type
Other
Intervention Name(s)
occlusion of tubes
Intervention Description
to occlude the fallopian tubes
Intervention Type
Other
Intervention Name(s)
non occlusion of tubes
Intervention Description
not to occlude the tubes
Primary Outcome Measure Information:
Title
the number of women who will become pregnant
Description
number of women who will have positive pregnancy test
Time Frame
3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with infertility
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women with infertility
Exclusion Criteria:
women with medical disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Alalfy
Phone
01002611058
Email
mahmoudalalfy@ymail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy
Organizational Affiliation
Algezeera hospitaland National Research Centre ,Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aljazeera( Al Gazeera) hospital
City
Giza
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, PhD
Phone
+201002611058
Ext
+2
Email
mahmoudalalfy@ymail.com
12. IPD Sharing Statement
Learn more about this trial
Hysterosalpingography and Hysteroscopy in ICSI
We'll reach out to this number within 24 hrs