Back to resultsEndometrial Scratching in Couples With Unexplained Subfertility (ESUS)
Primary Purpose
Subfertility
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
scratching
Sponsored by
About this trial
This is an interventional treatment trial for Subfertility focused on measuring Unexplained infertility-endometrial scratching, effect of endometrial biopsy (scratching) on clinical pregnancy rates in women with unexplained infertility
Eligibility Criteria
Inclusion Criteria:
- women aged between 20 and 39 years with at least one year of infertility
- regular menstruation with the length of the cycle between 22-34 days and ovulation confirmed by appropriately timed mid-luteal progesterone
- fertile semen variables
- bilateral tubal patency (demonstrated by laparoscopy or hysterosalpingography).
Sites / Locations
- Mansoura University Teaching Hospital Gynecology outpatient clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Scrathcing
Control
Arm Description
scratching of endometrium on day 21-26 of a spontaneous menstrual cycle
Uterine sounding on day 21-26 of a spontaneous menstrual cycle
Outcomes
Primary Outcome Measures
Clinical pregnancy rate
Secondary Outcome Measures
miscarriage rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01412606
Brief Title
Endometrial Scratching in Couples With Unexplained Subfertility
Acronym
ESUS
Official Title
Endometrial Scratching in Couples With Unexplained Subfertility
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Endometrial scratching in luteal phase of a spontaneous menstrual cycle may increase pregnancy rate in women with unexplained infertility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility
Keywords
Unexplained infertility-endometrial scratching, effect of endometrial biopsy (scratching) on clinical pregnancy rates in women with unexplained infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Scrathcing
Arm Type
Experimental
Arm Description
scratching of endometrium on day 21-26 of a spontaneous menstrual cycle
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Uterine sounding on day 21-26 of a spontaneous menstrual cycle
Intervention Type
Procedure
Intervention Name(s)
scratching
Intervention Description
scratching endometrium on day 21-26 of a spontaneous menstrual cycle
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
miscarriage rate
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women aged between 20 and 39 years with at least one year of infertility
regular menstruation with the length of the cycle between 22-34 days and ovulation confirmed by appropriately timed mid-luteal progesterone
fertile semen variables
bilateral tubal patency (demonstrated by laparoscopy or hysterosalpingography).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Gibreel, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Teaching Hospital Gynecology outpatient clinic
City
Mansoura
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
23106834
Citation
Gibreel A, Badawy A, El-Refai W, El-Adawi N. Endometrial scratching to improve pregnancy rate in couples with unexplained subfertility: a randomized controlled trial. J Obstet Gynaecol Res. 2013 Mar;39(3):680-4. doi: 10.1111/j.1447-0756.2012.02016.x. Epub 2012 Oct 29. Erratum In: J Obstet Gynaecol Res. 2021 Aug;47(8):2936.
Results Reference
derived
Learn more about this trial
Endometrial Scratching in Couples With Unexplained Subfertility
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