Tolerability and Satisfaction With Evie
Infertility
About this trial
This is an interventional diagnostic trial for Infertility focused on measuring Infertility, Intrauterine Insemination, Slow-release Insemination, Evie
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
Sites / Locations
- Women's Institute at Carolinas Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Evie Slow-Release Insemination Device
Traditional Intrauterine Insemination
Preliminary 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 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).