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Office Hysteroscopy and Endometrial Snip Improve Intrauterine Insemination Outcome

This study has been completed.
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University Identifier:
First received: February 26, 2012
Last updated: December 27, 2014
Last verified: December 2014
Endometrial injury had been studied before prior to intracytoplasmic sperm injection (ICSI) cycles , in cases of repeated implantation failure. It is found that it will improve the implantation rate.

Condition Intervention Phase
Procedure: Office hysteroscopy and endometrial snip
Procedure: Office hysteroscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Does Office Hysteroscopy and Endometrial Snip Improve IUI Outcome? : a Randomized Controlled Trial

Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 10 month ]
    Positive pregnancy test with fetal heart activity

Secondary Outcome Measures:
  • Ongoing pregnancy rate [ Time Frame: 12 month ]
    Pregnancy Continued after 12weeks

Enrollment: 332
Study Start Date: February 2012
Study Completion Date: October 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Office hysteroscopy and endometrial snip
Office hysteroscopy and endometrial snip
Procedure: Office hysteroscopy and endometrial snip
Office hysteroscopy with endometrial snip
Other Name: Office hysteroscopy combined with endometrial snip
Active Comparator: Office hyteroscopy
Office hysteroscopy
Procedure: Office hysteroscopy
Office hysteroscopy
Other Name: Outpatient hysteroscopy

Detailed Description:
The investigators can combine office hysteroscopy to diagnose hidden endometrial pathology, with hysteroscopically guided endometrial snip from the fundus of the uterus, trying to improve the pregnancy rate.

Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18- 38 years old
  • at least one patent tube
  • unexplained infertility, anovulation, mild to moderate male factor infertility
  • previous failed IUI

Exclusion Criteria:

  • indicated for ICSI
  Contacts and Locations
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Please refer to this study by its identifier: NCT01544426

Kasr Al-AINY hospital
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Principal Investigator: Waleed El-khayat, M.D. faculty of medicine cairo university
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Waleed El-khayat, Assistant professor, Cairo University Identifier: NCT01544426     History of Changes
Other Study ID Numbers: 42012
Study First Received: February 26, 2012
Last Updated: December 27, 2014

Keywords provided by Cairo University:
Office hysteroscopy,
intrauterine insemination
endometrial scrap

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on May 23, 2017