Office Hysteroscopy and Endometrial Snip Improve Intrauterine Insemination Outcome

Phase 3

Completed

• Conditions: Infertility
• Interventions: Procedure: Office hysteroscopy and endometrial snip; Procedure: Office hysteroscopy

• Registration Number: NCT01544426
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-26
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-06
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-27
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 332

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Office hysteroscopy and endometrial snip	Office hysteroscopy and endometrial snip	Office hysteroscopy and endometrial snip
Office hyteroscopy	Office hysteroscopy	Office hysteroscopy

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	10 month	Positive pregnancy test with fetal heart activity

Secondary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	12 month	Pregnancy Continued after 12weeks

Trial Locations

Locations (1)

Kasr Al-AINY hospital; 🇪🇬 Cairo, Egypt