Uterine Scratching in Intra-Uterine Insemination

Study Overview
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Brief Summary
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This study will evaluate the potential benefits of uterine injury during the follicular phase of an intra-uterine insemination cycle on the rate of ongoing pregnancy during the first trimester ultrasound.

Detailed Description
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Infertility is defined as the absence of conception after a year of unprotected intercourse. In 10 to 30 % of patients, the cause of the infertility is unknown. An emerging practice in unexplained infertility has been to cause a uterine trauma prior to treatment. This is done by doing a small endometrial scratch with a pipelle. This intervention has been study in IVF and has been shown beneficial. Theoretically, the uterine scratching could increase the immune response and the vascularization of the endometrium which could help in embryo implantation. However, there is very few data concerning scratching in intrauterine insemination. The studies are mostly small studies and the results are often contradictory. In this randomized controlled trial, the investigators will evaluate the effect of uterine scratching during the follicular phase of an insemination cycle on the pregnancy rate of a large cohort of unexplained infertile couples.

Official Title
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The Impact of Uterine Scratching Prior to Intra-Uterine Insemination in Unexplained Infertility, a Randomized Controlled Trial

Conditions
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Infertility, Unexplained Infertility

Intervention / Treatment
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* Procedure: Endometrial scratching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unexplained infertility for over 12 months if under 35 years old or over 6 months if 35 years old and above. At least one permeable tube on hysterosonography or hysterosalpingography within the last 2 years or vaginal delivery in the last 3 years. Antral follicular count over 5. Normal or mild male factor. Normal uterine cavity. An IUI prescription. Exclusion Criteria: Polycystic ovary syndrome with irregular menstrual cycles over 45 days Severe endometriosis IUI with Donor sperm Patient with invasive intra-uterine procedure in the last 3 months. Contraindication to endometrial biopsy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endometrial scratching group<br>Endometrial scratching will be done with a Pipelle in uterus. | Procedure: Endometrial scratching<br>* Endometrial Biopsy by aspiration with a pipelle<br>* Other names: Endometrial Biopsy;|
| No Intervention: Control group<br>This group will proceed with intrauterine insemination without endometrial scratching according to clinic's standard procedure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Pregnancy Rate measured during the first trimester ultrasound. | Ongoing pregnancy during the first trimester ultrasound after an intrauterine insemination (IUI) cycle. | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Secondary pregnancy rate. | Ongoing pregnancy during the first trimester ultrasound in the 3 IUI cycles following a scratching | 6 months | 
| Safety - Side effects | Evaluate side effects related to the intrauterine scratching | 6 months for all 3 intrauterine insemination | 
| Safety - Complications | Evaluate complications related to intrauterine scratching | 6 months for all 3 intrauterine insemination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intra-uterine insemination, endometrial injury, scratching