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Endometrial Scratching in Couples With Unexplained Subfertility (ESUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ahmed Gibreel, Mansoura University
ClinicalTrials.gov Identifier:
NCT01412606
First received: August 8, 2011
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  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 Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endometrial Scratching in Couples With Unexplained Subfertility

Resource links provided by NLM:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   20 Years to 39 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Mansoura University

Additional 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
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

Additional relevant MeSH terms:
Adenoma
Infertility
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 16, 2013