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OpenTrials
Completed

NCT Number: NCT01969812

Tolerability and Satisfaction With Evie

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Institute at Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evie Slow-release Insemination Device

Device

Traditional Intrauterine Insemination

Other

Primary outcomes

  1. Patient Tolerability and Satisfaction SF36

    Time frame: 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 outcomes

  1. Cramping

    Time frame: 1 month

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

  2. Pregnancy Rates

    Time frame: 3 months

    Pregnancy rates based on blood and urine beta-HCG.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 25, 2013
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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