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Office Hysteroscopy and Endometrial Snip Improve Intrauterine Insemination Outcome

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ClinicalTrials.gov Identifier: NCT01544426
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University

Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Procedure: Office hysteroscopy and endometrial snip Procedure: Office hysteroscopy Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Does Office Hysteroscopy and Endometrial Snip Improve IUI Outcome? : a Randomized Controlled Trial
Study Start Date : February 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
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



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


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



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

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

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): NCT01544426


Locations
Egypt
Kasr Al-AINY hospital
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Waleed El-khayat, M.D. Cairo University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Waleed El-khayat, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT01544426     History of Changes
Other Study ID Numbers: 42012
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by Waleed El-khayat, Cairo University:
Office hysteroscopy,
intrauterine insemination
endometrial scrap

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