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Office Hysteroscopy and Endometrial Snip Improve Intrauterine Insemination Outcome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01544426
First Posted: March 6, 2012
Last Update Posted: December 30, 2014
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):
Waleed El-khayat, Cairo University
  Purpose
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
Infertility Procedure: Office hysteroscopy and endometrial snip Procedure: Office hysteroscopy Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Waleed El-khayat, 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.
  Eligibility

Information from the National Library of Medicine

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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
  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): NCT01544426


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

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 Submitted: February 26, 2012
First Posted: March 6, 2012
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