Tolerability and Satisfaction With Evie

Study Overview
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Brief Summary
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The purpose of this study is to determine patient satisfaction and tolerability of the Evie® slow-release insemination device for US population. Additionally, to assess cramping with the device and to determine pregnancy rates using the slow insemination device compared to standard IUI.

Official Title
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Patient Satisfaction and Tolerability With the Evie® Slow-Release Insemination Device: Pilot Study

Conditions
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Infertility

Intervention / Treatment
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* Device: Evie Slow-release Insemination Device
* Other: Traditional Intrauterine Insemination


Participation Criteria
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Eligibility Criteria
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The inclusion criteria: Infertile women age ≤39 undergoing first IUI cycle for relatively unexplained infertility IRB approval and informed consent signed Exclusion criteria: Women <18 or ≥40 years old Women with abnormalities of the uterine cavity Women with tubal occlusion History of documented pelvic adhesions or endometriosis Uncorrected ovulatory dysfunction Uncorrected thyroid function AMH <1 ng/mL <5 million total motile sperm expected for insemination in prior analyses or on the day of sperm preparation for insemination

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evie Slow-Release Insemination Device<br>Preliminary studies in Europe have shown increased pregnancy rates using slow-release insemination. Evie slow-release insemination device is a device that is FDA approved. This device has been used in Europe, it has not yet been used at Carolinas Medical Center, by the Women's Institute. The technique for using this device involves loading a pump syringe with the prepared sperm, placing a balloon-secured catheter and syringe in the patient's sounded uterus, and connecting the insemination syringe to the catheter. The slow-release insemination occurs for 4 hours after the insertion of the catheter. The removal procedure, which can be performed by the patient if desired, involves deflating the catheter balloon and removing the catheter. | Device: Evie Slow-release Insemination Device<br> <br> |
| Active Comparator: Traditional Intrauterine Insemination<br>Traditional IUI is one of the treatment modalities for infertility that allows sperm to bypass the cervix and shortens the distance to the fallopian tubes for fertilization. The pregnancy rates for IUI with clomiphene citrate for couples with relatively unexplained infertility have been found to be 7.6% (for women 21-39 years old with up to 3 cycles of IUI with clomiphene). | Other: Traditional Intrauterine Insemination<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Tolerability and Satisfaction SF36 | The primary outcome variable will be patient tolerability and satisfaction, based on a standardized SF-36 survey. Total score 0-100 with higher score denoting better outcomes | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cramping | Cramping assessment based on a Numerical Rating Scale 0 to 10. Higher score denotes worse cramping. | 1 month | 
| Pregnancy Rates | Pregnancy rates based on blood and urine beta-HCG. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, Intrauterine Insemination, Slow-release Insemination, Evie