Tolerability and Satisfaction With Evie
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Infertility |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 2/1/2018 |
| Start Date: | January 2014 |
| End Date: | March 2015 |
Patient Satisfaction and Tolerability With the Evie® Slow-Release Insemination Device: Pilot Study
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.
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.
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
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