NCT02315040

EVIE-Study: Slow Release Insemination Versus Standard Intrauterine Insemination Study

Testing the Effect of Intrauterine Slow Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Standard Intrauterine Insemination (IUI)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Overall Study Design and Plan Description * The study will be conducted on women with fertility difficulties who are designated for intrauterine insemination treatment (IUI). The research sample size is 137 treatment cycles per group (total of 274 treatment cycles). The women will be randomly divided into two groups. Some will undergo the standard bolus IUI treatment and others will be treated with the EVIE Slow Release Insemination method (SRI). Women who fail to conceive in the first treatment will next receive the alternative treatment. This means that a woman treated with the IUI method who does not become pregnant will then be treated with SRI, and vice versa (crossover method). The study will include women treated with Clomiphene Citrate or with other Gonadotropin-based treatment. Every couple treated will undergo at least 2 insemination cycles (unless pregnancy has already been achieved). * Before beginning the hormone treatment, each couple will have the trial procedure explained to them. This explanation will include all the detailed information and instruction about the IUI and the Slow Release Insemination methods. A Patient Information Sheet will be available to them. * Preparation of the spermatozoa for intra uterine insemination will be identical to the method performed currently before IUI. Approximately two weeks after the insemination treatment, a blood sample will be taken from the woman to check for Beta hCG levels to indicate pregnancy. Hypothesis: SRI leads to higher pregnancy rates compared to standard IUI Primary endpoint: • Pregnancy rate Effect of controlled Intra-uterine slow release insemination on the pregnancy rate of women designated for intra uterine insemination in comparison to the accepted IUI method.

Conditions

• Insemination

Interventions

Type	Name	Description
DEVICE	EVIE	EVIE is a small, mechanical, single use pump that mimics natural fertilization by introducing sperm into the uterus over a period of 4 hours, rather than all at once as in conventional IUI
OTHER	Standard Intrauterine Insemination	standard intrauterine insemination procedure

Timeline

• Start date: 2012-03-01
• Primary completion: 2017-07-01
• Completion: 2017-08-01
• First posted: 2014-12-11
• Last updated: 2017-06-07

Locations

12 sites across 4 countries: Austria, France, Germany, United Kingdom