Does Endometrial Injury Improve Intrauterine Insemination Outcome?

Infertility Clinical Trial

Official title:

Endometrial Injury May Increase the Pregnancy Rate in Patients Undergoing Intrauterine Insemination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542280
• Other study ID #: abahaa050301
• Status: Completed
• Phase: Phase 3
• First received: September 3, 2015
• Last updated: December 3, 2015
• Start date: July 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• endometrial injury.
Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.
• intrauterine insemination
Placement of washed sperm in the uterus using a catheter, around the time of ovulation.

Drug:
• ovarian stimulation
Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chemical Pregnancy Rate	Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.	two weeks after intrauterine insemination	Yes
Primary	Clinical Pregnancy Rate	Ultrasound detection of an intrauterine positive fetal heart pulsations	six weeks	Yes