Tolerability and Satisfaction With Evie

Not Applicable

Completed

• Conditions: Infertility

• 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

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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