Does Endometrial Injury Improve Intrauterine Insemination Outcome?

Phase 3

Completed

• Conditions: Infertility
• Interventions: Procedure: endometrial injury.; Procedure: intrauterine insemination; Drug: ovarian stimulation

• Registration Number: NCT02542280
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

The investigator suggests that local endometrial injury using pipelle catheter performed in the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy rates among patients undergoing intrauterine insemination.

Detailed Description

In a selected group of patients with repeated implantation failure, endometrial injury in the preceding cycle may improve ICSI outcome.

Little is known about the efficacy of this procedure in improving intrauterine insemination outcome.

Also little is known about the effect of this procedure if done in the stimulation cycle weather in ICSI or intrauterine insemination cycles.

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2015-07
• Study Completion: 2015-09
• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-07
• Results First Submitted: 2015-10-02
• Status Verified: 2015-11
• Results First Submitted QC: 2015-12-03
• Last Update Submitted: 2015-12-03
• Results First Posted: 2016-01-08
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 360

Inclusion Criteria

• 18 - 38 years.
• patent fallopian tunes.
• mild male factor.
• anovulation.
• unexplained infertility.

Exclusion Criteria

• indications for ICSI.
• evidence of pelvic inflammatory disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endometrial injury	endometrial injury.	Endometrial injury during ovarian stimulation combined with intrauterine insemination.
endometrial injury	intrauterine insemination	Endometrial injury during ovarian stimulation combined with intrauterine insemination.
no endometrial injury	intrauterine insemination	Ovarian stimulation combined with intrauterine insemination.
endometrial injury	ovarian stimulation	Endometrial injury during ovarian stimulation combined with intrauterine insemination.
no endometrial injury	ovarian stimulation	Ovarian stimulation combined with intrauterine insemination.

Primary Outcome Measures

Name	Time	Method
Chemical Pregnancy Rate	two weeks after intrauterine insemination	Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.
Clinical Pregnancy Rate	six weeks	Ultrasound detection of an intrauterine positive fetal heart pulsations