EVIE :Slow Release Insemination Vs Standard Intrauterine Insemination
Research type
Research Study
Full title
Testing the Effect of Intrauterine Slow Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Standard Intrauterine Insemination (IUI)
IRAS ID
193570
Contact name
Christian Egarter
Contact email
Sponsor organisation
Reproductive Sciences Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 5 days
Research summary
•The study will be conducted on women with fertility difficulties who are designated for intrauterine insemination treatment (IUI). The research sample size is 250 patients. 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).\n•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.\n•Preparation of the spermatozoa for intra uterine insemination will be identical to the method performed currently before IUI.\nApproximately two weeks after the insemination treatment, a blood sample will be taken from the woman to check for Beta hCG levels to indicate pregnancy.\n\nHypothesis:\n\nSRI leads to higher pregnancy rates compared to standard IUI\n\nPrimary endpoint:\n\n- an accumulation of 250 cycles of slow release insemination (study group) and 250 cycles of regular IUI (control group)\n\n\n\n\n\n\n\n\n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0010
Date of REC Opinion
13 Jan 2016
REC opinion
Favourable Opinion