Tolerability and Satisfaction With Evie
Patient Satisfaction and Tolerability With the Evie® Slow-Release Insemination Device: Pilot Study
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2013
CompletedFirst Posted
Study publicly available on registry
October 25, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
November 17, 2021
CompletedApril 22, 2022
October 1, 2021
1.2 years
October 22, 2013
October 19, 2021
April 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Cramping
1 month
Pregnancy Rates
3 months
Study Arms (2)
Evie Slow-Release Insemination Device
EXPERIMENTALPreliminary 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 Intrauterine Insemination
ACTIVE COMPARATORTraditional 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).
Interventions
Eligibility Criteria
You may qualify if:
- Infertile women age ≤39 undergoing first IUI cycle for relatively unexplained infertility
- IRB approval and informed consent signed
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women's Institute at Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
Related 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. doi: 10.1093/oxfordjournals.humrep.a137622.
PMID: 1577936BACKGROUNDReindollar 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.
PMID: 19531445BACKGROUNDWilliamson 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.
PMID: 16000093BACKGROUNDShort Form-36. Available at www.sf-36.org. Accessed on September 24, 2013.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bradley Hurst, M.D.
- Organization
- Atrium Health
Study Officials
- PRINCIPAL INVESTIGATOR
Brad Hurst, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2013
First Posted
October 25, 2013
Study Start
January 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
April 22, 2022
Results First Posted
November 17, 2021
Record last verified: 2021-10