Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Endometrial Scratching in Couples With Unexplained Subfertility (ESUS)

This study has been completed.
Information provided by (Responsible Party):
Ahmed Gibreel, Mansoura University Identifier:
First received: August 8, 2011
Last updated: August 28, 2012
Last verified: August 2012

Endometrial scratching in luteal phase of a spontaneous menstrual cycle may increase pregnancy rate in women with unexplained infertility.

Condition Intervention Phase
Procedure: scratching
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endometrial Scratching in Couples With Unexplained Subfertility

Resource links provided by NLM:

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • miscarriage rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 105
Study Start Date: July 2009
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Scrathcing
scratching of endometrium on day 21-26 of a spontaneous menstrual cycle
Procedure: scratching
scratching endometrium on day 21-26 of a spontaneous menstrual cycle
Placebo Comparator: Control
Uterine sounding on day 21-26 of a spontaneous menstrual cycle
Procedure: scratching
scratching endometrium on day 21-26 of a spontaneous menstrual cycle


Ages Eligible for Study:   20 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).
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Please refer to this study by its identifier: NCT01412606

Mansoura University Teaching Hospital Gynecology outpatient clinic
Mansoura, Egypt
Sponsors and Collaborators
Mansoura University
Principal Investigator: Ahmed Gibreel, MD Mansoura University
  More Information

No publications provided by Mansoura University

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ahmed Gibreel, Dr, Mansoura University Identifier: NCT01412606     History of Changes
Other Study ID Numbers: AG2
Study First Received: August 8, 2011
Last Updated: August 28, 2012
Health Authority: Egypt: Ministry of Higher Education

Keywords provided by Mansoura University:
Unexplained infertility-endometrial scratching
effect of endometrial biopsy (scratching) on clinical pregnancy rates in women with unexplained infertility processed this record on February 27, 2015