Tolerability and Satisfaction With Evie

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

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 Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Device: Evie Slow-release Insemination Device; Other: Traditional Intrauterine Insemination

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Women's Institute at Carolinas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Evie Slow-release Insemination Device
Active Comparator: 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).	Other: Traditional Intrauterine Insemination

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
• Muharib NS, Abdel Gadir A, Shaw RW. Slow release intrauterine insemination versus the bolus technique in the treatment of women with cervical mucus hostility. Hum Reprod. 1992 Feb;7(2):227-9. doi: 10.1093/oxfordjournals.humrep.a137622.
• Reindollar RH, Regan MM, Neumann PJ, Levine BS, Thornton KL, Alper MM, Goldman MB. A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial. Fertil Steril. 2010 Aug;94(3):888-99. doi: 10.1016/j.fertnstert.2009.04.022. Epub 2009 Jun 16.
• Short Form-36. Available at www.sf-36.org. Accessed on September 24, 2013.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: October 22, 2013
• First Posted (Estimate): October 25, 2013

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Infertility; Intrauterine Insemination; Slow-release Insemination; Evie
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Evie 2013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No