Office Hysteroscopy and Endometrial Snip Improve Intrauterine Insemination Outcome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Cairo University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University
ClinicalTrials.gov Identifier:
NCT01544426
First received: February 26, 2012
Last updated: March 5, 2012
Last verified: February 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Does Office Hysteroscopy and Endometrial Snip Improve IUI Outcome? : a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 10 month ] [ Designated as safety issue: No ]
    Positive pregnancy test with fetal heart activity


Secondary Outcome Measures:
  • Ongoing pregnancy rate [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Pregnancy Continued after 12weeks


Estimated Enrollment: 120
Study Start Date: February 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: October 2012 (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

Ages Eligible for Study:   18 Years to 38 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544426

Contacts
Contact: Waleed El-khayat, M.D. 23655215 ext +2 Waleed_Elkhart@yahoo.com

Locations
Egypt
Kasr Al-AINY hospital Recruiting
Cairo, Egypt
Contact: Waleed El-khayat, M.D.    23655215 ext +2    Waleed_elkhyat@yahoo.com   
Principal Investigator: Waleed El-khayat, M.D.         
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Waleed El-khayat, M.D. Faculty of medicine, Cairo University
  More Information

No publications provided

Responsible Party: Waleed El-khayat, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT01544426     History of Changes
Other Study ID Numbers: 42012
Study First Received: February 26, 2012
Last Updated: March 5, 2012
Health Authority: Egypt: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 22, 2014