Back to resultsEndometrial Assessment of Women With Uterine Infection
Primary Purpose
Infertility
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
manipulation of endometrium
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Women with infertility age from 20-40 years
Exclusion Criteria:
- Any factor of infertility
Sites / Locations
- Algazeerah and Kasralainy hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Hysteroscopic evaluation
control group
Arm Description
Hysteroscopic evaluation Active group : infection Manipulation of endometrium with saline
Hysteroscopic evaluation Control group : No infection
Outcomes
Primary Outcome Measures
the number of women who will get pregnant after IUI
How many women will get pregnant after IUI
Secondary Outcome Measures
Full Information
NCT ID
NCT03824184
First Posted
January 28, 2019
Last Updated
September 23, 2023
Sponsor
Aljazeera Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03824184
Brief Title
Endometrial Assessment of Women With Uterine Infection
Official Title
Endometrial Assessment Women With Infertility Who Will do IUI and ICSI
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
May 3, 2024 (Anticipated)
Study Completion Date
June 20, 2024 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility .
Detailed Description
Implantation is the main rate limiting step in IVF outcome. Implantation is described at the cellular and the molecular levels by adhesion or fixation of a good quality embryo to receptive endometrium within a critical period of time, which is called the window of implantation
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hysteroscopic evaluation
Arm Type
Active Comparator
Arm Description
Hysteroscopic evaluation Active group : infection Manipulation of endometrium with saline
Arm Title
control group
Arm Type
Other
Arm Description
Hysteroscopic evaluation Control group : No infection
Intervention Type
Procedure
Intervention Name(s)
manipulation of endometrium
Other Intervention Name(s)
Saline infusion
Intervention Description
Manipulation of endometrium with saline
Primary Outcome Measure Information:
Title
the number of women who will get pregnant after IUI
Description
How many women will get pregnant after IUI
Time Frame
within 4 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
infertile women
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women with infertility age from 20-40 years
Exclusion Criteria:
Any factor of infertility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Alalfy, PhD
Phone
01002611058
Email
mahmoudalalfy@ymail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy
Organizational Affiliation
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Algazeerah and Kasralainy hospital
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
Phone
+201002611058
Email
mahmoudalalfy@ymail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Elgazzar, M.D
Phone
+201014005959
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Endometrial Assessment of Women With Uterine Infection
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