Tolerability and Satisfaction With Evie

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01969812
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Duration (Months): 13.9
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Device: Evie Slow-release Insemination Device; Other: Traditional Intrauterine Insemination	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Patient Satisfaction and Tolerability With the Evie® Slow-Release Insemination Device: Pilot Study
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Cramping [1 month]

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

2. Pregnancy Rates [3 months]

   Pregnancy rates based on blood and urine beta-HCG.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women's Institute at Carolinas Medical Center	Charlotte	North Carolina	United States	28204

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Brad Hurst, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. Review.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT01969812
• Other Study ID Numbers: Evie 2013
• First Posted: Oct 25, 2013
• Last Update Posted: Apr 22, 2022
• Last Verified: Oct 1, 2021

• 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
• Keywords provided by Wake Forest University Health Sciences: Infertility; Intrauterine Insemination; Slow-release Insemination; Evie
• Additional relevant MeSH terms: Infertility

Study Results

Participant Flow

Arm/Group Title	Evie Slow-Release Insemination Device	Traditional Intrauterine Insemination
Arm/Group 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. Evie Slow-release Insemination Device	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). Traditional Intrauterine Insemination
Period Title: Overall Study
STARTED	12	10
COMPLETED	12	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Evie Slow-Release Insemination Device	Traditional Intrauterine Insemination	Total
Arm/Group 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. Evie Slow-release Insemination Device	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). Traditional Intrauterine Insemination	Total of all reporting groups
Overall Participants	12	10	22
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 100%	10 100%	22 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	12 100%	10 100%	22 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	12 100%	10 100%	22 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	12 100%	10 100%	22 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%	10 100%	22 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evie Slow-Release Insemination Device	Traditional Intrauterine Insemination
Arm/Group 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. Evie Slow-release Insemination Device	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). Traditional Intrauterine Insemination
Measure Participants	12	10
Mean (Standard Deviation) [units on a scale]	76.8 (15.90)	84.2 (11.28)

2. Secondary Outcome

Title	Cramping
Description	Cramping assessment based on a Numerical Rating Scale 0 to 10. Higher score denotes worse cramping.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evie Slow-Release Insemination Device	Traditional Intrauterine Insemination
Arm/Group 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. Evie Slow-release Insemination Device	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). Traditional Intrauterine Insemination
Measure Participants	12	10
Mean (Standard Deviation) [score on a scale]	3.85 (2.00)	2.42 (1.93)

3. Secondary Outcome

Title	Pregnancy Rates
Description	Pregnancy rates based on blood and urine beta-HCG.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evie Slow-Release Insemination Device	Traditional Intrauterine Insemination
Arm/Group 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. Evie Slow-release Insemination Device	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). Traditional Intrauterine Insemination
Measure Participants	12	10
Count of Participants [Participants]	4 33.3%	3 30%

Adverse Events

Arm/Group Title	Evie Slow-Release Insemination Device		Traditional Intrauterine Insemination
Arm/Group 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. Evie Slow-release Insemination Device		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). Traditional Intrauterine Insemination
All Cause Mortality
	Evie Slow-Release Insemination Device		Traditional Intrauterine Insemination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/10 (0%)
Serious Adverse Events
	Evie Slow-Release Insemination Device		Traditional Intrauterine Insemination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Evie Slow-Release Insemination Device		Traditional Intrauterine Insemination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.