Does Endometrial Injury Improve Intrauterine Insemination Outcome?

NCT02542280 — Phase 3, Completed, 360 participants, Ain Shams Maternity Hospital

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

Registry	NCT02542280
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	360 (Actual)
Sponsor	Ain Shams Maternity Hospital (Other)
Conditions	Infertility
Interventions	endometrial injury., intrauterine insemination, ovarian stimulation (Procedure, drug)
Dates	start 2013-07-01, primary completion 2015-07-01, completion 2015-09-01, first posted 2015-09-07, last updated 2016-01-08

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
endometrial injury	Experimental	Procedure: endometrial injury.; Procedure: intrauterine insemination; Drug: ovarian stimulation	Endometrial injury during ovarian stimulation combined with intrauterine insemination.
no endometrial injury	Active comparator	Procedure: intrauterine insemination; Drug: ovarian stimulation	Ovarian stimulation combined with intrauterine insemination.

endometrial injury. (Procedure), also known as endometrial scratch., endometrial sample.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.
intrauterine insemination (Procedure), also known as artificial insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
ovarian stimulation (Drug), also known as controlled ovarian hyperstimulatiom: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to 38 Years

Inclusion Criteria:

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

Exclusion Criteria:

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

+Posted results

Participant flow

Milestone	Endometrial Injury	no Endometrial Injury
Started	174	175
Completed	162	167
Not completed	12	8

Outcome results

Chemical Pregnancy Rate (Primary), Number, participants: Endometrial Injury 40; no Endometrial Injury 19
Clinical Pregnancy Rate (Primary), Number, participants: Endometrial Injury 32; no Endometrial Injury 13

Adverse events

Arm	Deaths	Serious adverse events	Other adverse events
Endometrial Injury	0	0/162 (0.0%)	0/162 (0.0%)
no Endometrial Injury	0	0/167 (0.0%)	0/167 (0.0%)

+Investigators

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