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Endometrial Scratching in Couples With Unexplained Subfertility (ESUS)

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ClinicalTrials.gov Identifier: NCT01412606
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : August 30, 2012
Sponsor:
Information provided by (Responsible Party):
Ahmed Gibreel, Mansoura University

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

Condition or disease Intervention/treatment Phase
Subfertility Procedure: scratching Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endometrial Scratching in Couples With Unexplained Subfertility
Study Start Date : July 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : June 2011

Arm Intervention/treatment
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




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

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


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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).

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

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 Posted: August 9, 2011    Key Record Dates
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