Tolerability and Satisfaction With Evie

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Device: Evie Slow-release Insemination Device; Other: Traditional Intrauterine Insemination

• Registration Number: NCT01969812
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-25
• Study Start: 2014-01
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2021-10
• Results First Submitted: 2021-10-19
• Results First Submitted QC: 2021-10-19
• Results First Posted: 2021-11-17
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evie Slow-Release Insemination Device	Evie Slow-release Insemination Device	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.
Traditional Intrauterine Insemination	Traditional Intrauterine Insemination	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).

Primary Outcome Measures

Name	Time	Method
Patient Tolerability and Satisfaction SF36	1 month	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Women's Institute at Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States