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Completed

NCT Number: NCT02542280

Does Endometrial Injury Improve Intrauterine Insemination Outcome?

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

endometrial injury.

Procedure

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.

Intrauterine Insemination

Procedure

Placement of washed sperm in the uterus using a catheter, around the time of ovulation.

Other names: artificial insemination

ovarian stimulation

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 7, 2015
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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