search
Back to results

Tolerability and Satisfaction With Evie

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Evie Slow-release Insemination Device
Traditional Intrauterine Insemination
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility focused on measuring Infertility, Intrauterine Insemination, Slow-release Insemination, Evie

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Women's Institute at Carolinas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Evie Slow-Release Insemination Device

Traditional Intrauterine Insemination

Arm Description

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 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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cramping
Cramping assessment based on a Numerical Rating Scale 0 to 10. Higher score denotes worse cramping.
Pregnancy Rates
Pregnancy rates based on blood and urine beta-HCG.

Full Information

First Posted
October 22, 2013
Last Updated
April 20, 2022
Sponsor
Wake Forest University Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01969812
Brief Title
Tolerability and Satisfaction With Evie
Official Title
Patient Satisfaction and Tolerability With the Evie® Slow-Release Insemination Device: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Intrauterine Insemination, Slow-release Insemination, Evie

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evie Slow-Release Insemination Device
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Intrauterine Insemination
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Evie Slow-release Insemination Device
Intervention Type
Other
Intervention Name(s)
Traditional Intrauterine Insemination
Primary Outcome Measure Information:
Title
Patient Tolerability and Satisfaction SF36
Description
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 Outcome Measure Information:
Title
Cramping
Description
Cramping assessment based on a Numerical Rating Scale 0 to 10. Higher score denotes worse cramping.
Time Frame
1 month
Title
Pregnancy Rates
Description
Pregnancy rates based on blood and urine beta-HCG.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad Hurst, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Institute at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1577936
Citation
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.
Results Reference
background
PubMed Identifier
19531445
Citation
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.
Results Reference
background
PubMed Identifier
16000093
Citation
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.
Results Reference
background
Citation
Short Form-36. Available at www.sf-36.org. Accessed on September 24, 2013.
Results Reference
background

Learn more about this trial

Tolerability and Satisfaction With Evie

We'll reach out to this number within 24 hrs