Does Endometrial Injury Improve Intrauterine Insemination Outcome?

Study Overview
=================
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.

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.

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

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: endometrial injury.
* Procedure: intrauterine insemination
* Drug: ovarian stimulation


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endometrial injury<br>Endometrial injury during ovarian stimulation combined with intrauterine insemination. | Procedure: endometrial injury.<br>* Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.<br>* Other names: endometrial sample.;Procedure: intrauterine insemination<br>* Placement of washed sperm in the uterus using a catheter, around the time of ovulation.<br>* Other names: artificial insemination;Drug: ovarian stimulation<br>* Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.<br>* Other names: controlled ovarian hyperstimulatiom;|
| Active Comparator: no endometrial injury<br>Ovarian stimulation combined with intrauterine insemination. | Procedure: intrauterine insemination<br>* Placement of washed sperm in the uterus using a catheter, around the time of ovulation.<br>* Other names: artificial insemination;Drug: ovarian stimulation<br>* Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.<br>* Other names: controlled ovarian hyperstimulatiom;|

What is the study measuring?
-----------------
Primary Outcome Measures

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