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Does Endometrial Injury Improve Intrauterine Insemination Outcome?

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ClinicalTrials.gov Identifier: NCT02542280
Recruitment Status : Completed
First Posted : September 7, 2015
Results First Posted : January 8, 2016
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility Procedure: endometrial injury. Procedure: intrauterine insemination Drug: ovarian stimulation Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Endometrial Injury May Increase the Pregnancy Rate in Patients Undergoing Intrauterine Insemination
Study Start Date : July 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: controlled ovarian hyperstimulatiom


Outcome Measures
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Primary Outcome Measures :
  1. Chemical Pregnancy Rate [ Time Frame: two weeks after intrauterine insemination ]
    Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.

  2. Clinical Pregnancy Rate [ Time Frame: six weeks ]
    Ultrasound detection of an intrauterine positive fetal heart pulsations


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • indications for ICSI.
  • evidence of pelvic inflammatory disease.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02542280


Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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Principal Investigator: Ahmed Bahaa Lecturer in Obstetrics and Gynecology, faculty of medicine, Ain Shams University.
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ahmed Mohamed Bahaa Eldin Ahmed, lesturer in Obstetrics and Gynecology., Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02542280    
Other Study ID Numbers: abahaa050301
First Posted: September 7, 2015    Key Record Dates
Results First Posted: January 8, 2016
Last Update Posted: January 8, 2016
Last Verified: November 2015
Additional relevant MeSH terms:
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Infertility