N/A
Completed N=22
Tolerability and Satisfaction With Evie
Source: ClinicalTrials.gov NCT01969812 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Patient Tolerability and Satisfaction SF36 — 76.8; 84.2 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Tolerability and Satisfaction SF36 |
76.8; 84.2 | — |
| SECONDARY Cramping |
3.85; 2.42 | — |
| SECONDARY Pregnancy Rates |
4; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT01969812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.