Back to resultsOffice Hysteroscopy and Endometrial Snip Improve Intrauterine Insemination Outcome
Primary Purpose
Infertility
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Office hysteroscopy and endometrial snip
Office hysteroscopy
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Office hysteroscopy,, intrauterine insemination, endometrial scrap
Eligibility Criteria
Inclusion Criteria:
- 18- 38 years old
- at least one patent tube
- unexplained infertility, anovulation, mild to moderate male factor infertility
- previous failed IUI
Exclusion Criteria:
- indicated for ICSI
Sites / Locations
- Kasr Al-AINY hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Office hysteroscopy and endometrial snip
Office hyteroscopy
Arm Description
Office hysteroscopy and endometrial snip
Office hysteroscopy
Outcomes
Primary Outcome Measures
Clinical pregnancy rate
Positive pregnancy test with fetal heart activity
Secondary Outcome Measures
Ongoing pregnancy rate
Pregnancy Continued after 12weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01544426
Brief Title
Office Hysteroscopy and Endometrial Snip Improve Intrauterine Insemination Outcome
Official Title
Does Office Hysteroscopy and Endometrial Snip Improve IUI Outcome? : a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Endometrial injury had been studied before prior to intracytoplasmic sperm injection (ICSI) cycles , in cases of repeated implantation failure. It is found that it will improve the implantation rate.
Detailed Description
The investigators can combine office hysteroscopy to diagnose hidden endometrial pathology, with hysteroscopically guided endometrial snip from the fundus of the uterus, trying to improve the pregnancy rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Office hysteroscopy,, intrauterine insemination, endometrial scrap
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
332 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Office hysteroscopy and endometrial snip
Arm Type
Experimental
Arm Description
Office hysteroscopy and endometrial snip
Arm Title
Office hyteroscopy
Arm Type
Active Comparator
Arm Description
Office hysteroscopy
Intervention Type
Procedure
Intervention Name(s)
Office hysteroscopy and endometrial snip
Other Intervention Name(s)
Office hysteroscopy combined with endometrial snip
Intervention Description
Office hysteroscopy with endometrial snip
Intervention Type
Procedure
Intervention Name(s)
Office hysteroscopy
Other Intervention Name(s)
Outpatient hysteroscopy
Intervention Description
Office hysteroscopy
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Positive pregnancy test with fetal heart activity
Time Frame
10 month
Secondary Outcome Measure Information:
Title
Ongoing pregnancy rate
Description
Pregnancy Continued after 12weeks
Time Frame
12 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18- 38 years old
at least one patent tube
unexplained infertility, anovulation, mild to moderate male factor infertility
previous failed IUI
Exclusion Criteria:
indicated for ICSI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed El-khayat, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Al-AINY hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
26344351
Citation
El-Khayat W, Elsadek M, Saber W. Comparing the effect of office hysteroscopy with endometrial scratch versus office hysteroscopy on intrauterine insemination outcome: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:96-100. doi: 10.1016/j.ejogrb.2015.08.025. Epub 2015 Aug 28.
Results Reference
derived
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Office Hysteroscopy and Endometrial Snip Improve Intrauterine Insemination Outcome
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