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Endometrial Scratching in Couples With Unexplained Subfertility (ESUS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01412606
First Posted: August 9, 2011
Last Update Posted: August 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ahmed Gibreel, Mansoura University
  Purpose
Endometrial scratching in luteal phase of a spontaneous menstrual cycle may increase pregnancy rate in women with unexplained infertility.

Condition Intervention Phase
Subfertility Procedure: scratching Phase 2 Phase 3

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

Further study details as provided by Ahmed Gibreel, Mansoura University:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • miscarriage rate [ Time Frame: 6 months ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412606


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ahmed Gibreel, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT01412606     History of Changes
Other Study ID Numbers: AG2
First Submitted: August 8, 2011
First Posted: August 9, 2011
Last Update Posted: August 30, 2012
Last Verified: August 2012

Keywords provided by Ahmed Gibreel, Mansoura University:
Unexplained infertility-endometrial scratching
effect of endometrial biopsy (scratching) on clinical pregnancy rates in women with unexplained infertility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female