Tolerability and Satisfaction With Evie

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969812
• Other study ID #: Evie 2013
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: October 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Evie Slow-release Insemination Device

Other:
• Traditional Intrauterine Insemination

Locations

Country	Name	City	State
United States	Women's Institute at Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cramping	Cramping assessment based on a Numerical Rating Scale 0 to 10. Higher score denotes worse cramping.	1 month
Secondary	Pregnancy Rates	Pregnancy rates based on blood and urine beta-HCG.	3 months