Does Endometrial Injury Improve Intrauterine Insemination Outcome?

December 3, 2015 updated by: Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: endometrial injury
Endometrial injury during ovarian stimulation combined with intrauterine insemination.
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.
Other Names:
  • endometrial scratch.
  • endometrial sample.
Procedure: intrauterine insemination
Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
Other Names:
  • artificial insemination
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.
Other Names:
  • controlled ovarian hyperstimulatiom
Active Comparator: no endometrial injury
Ovarian stimulation combined with intrauterine insemination.
Procedure: intrauterine insemination
Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
Other Names:
  • artificial insemination
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.
Other Names:
  • controlled ovarian hyperstimulatiom

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Principal Investigator: Ahmed Bahaa, Lecturer in Obstetrics and Gynecology, faculty of medicine, Ain Shams University.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • abahaa050301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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