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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02315040
Study type Interventional
Source Medical University of Vienna
Contact Julian Marschalek, MD
Phone +4314040028160
Email julian.marschalek@meduniwien.ac.at
Status Recruiting
Phase Phase 3
Start date March 2012
Completion date August 2017

See also
  Status Clinical Trial Phase
Completed NCT05999591 - Total Motile Sperm Count and Pregnancy Rate From Intrauterine Insemination
Recruiting NCT03435809 - Pozzi Forceps in Intrauterine Insemination N/A
Completed NCT01999959 - Effect of Pertubation on Pregnancy Rates Before Intrauterine Insemination Treatment Phase 2
Completed NCT00809952 - Ultrasound Guided Artificial Insemination Phase 4