Tolerability and Satisfaction With Evie

N/ACompletedNCT01969812

Wake Forest University Health Sciences22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Infertility

Interventions

Evie Slow-release Insemination DeviceDEVICE

Traditional Intrauterine InseminationOTHER

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Women's Institute at Carolinas Medical Center

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

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

Time frame: 1 month

Secondary Outcomes

Cramping

Cramping assessment based on a Numerical Rating Scale 0 to 10. Higher score denotes worse cramping.

Time frame: 1 month

Pregnancy Rates

Pregnancy rates based on blood and urine beta-HCG.

Time frame: 3 months

Data from ClinicalTrials.gov

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