NOVEL

Clinical Studies

 

Having changed little since in the 1950s, because of relatively low success rates of bolus IUI, Muharib, Gadir & Shaw at the Royal Free Hospital in London, postulated slow release insemination would lead to greater success rates.  Their research demonstrated more than a doubling of the success rates.  The results went on to be published in Human Reproduction in 1992. This study led to the concept and eventual development of EVIE (an ambulatory, disposable device with a mechanical pump). Click Here to see the study results.

On realizing the potential for slow release insemination, an Israeli company (Fertiligent) developed a precursor to EVIE. Testing took place in two centers between 2004 and 2007, comparing the effect of slow release insemination (SRI) with bolus IUI.  The SRI method again showed at least a doubling of the pregnancy success rates compared with the standard bolus IUI method.  The results were published in February 2014.  This enabled the device to achieve the CE Mark and gain FDA 510(k) approval. Click Here to see results from the testing.

 

 

Both studies combined

These first two studies are considered two arms of the same study, as identical study protocol was used.  A meta analysis was also conducted in the publication to combine results of the Fertiligent data plus the Muharib et al data. As the meta analysis had a higher power, this had the potential to demonstrate the true effect of slow release insemination compared with standard bolus IUI.

The meta analysis demonstrated a combined relative result of these studies is 2.64 (p=0.02), achieving more than a doubling of the success rates using slow release insemination compared with standard bolus IUI method, which was statistically significant. Click Here to see the results in more detail.

The results were even more positive in the under 35 age group, however this did not achieve statistical significance in the meta analysis.

 

European clinical study

RSL has just concluded a European clinical study based on the same protocol as the previous two studies.

This research also concluded more than a doubling of success rates compared to standard bolus IUI for woman under 35 years of age.

  • Total of 11 participating centers
  • Total of 284 treatments (approximately the same number of IUI and SRI treatments) on 182 patients
  • Total age range 21 to 41
  • 172 procedures performed on patients under 35 (83 IUI and 89 SRI). In this age group, the pregnancy rate for SRI was 16.9% and the success for IUI was 7.2%. This doubling achieved statistical significance.
  • Across all age ranges the pregnancy rate for SRI was 13% and for IUI 10% (not statistically significant).

The results can be viewed if you Click Here

 

All studies combined

All results from all studies show a consistent doubling of pregnancy rates when SRI is compared to standard bolus IUI.  The European study is highly significant, as it was adequately powered and achieved statistical significance in results under 35 age group.  This data will be published later in the year to add to the growing body of evidence.  Preliminary analysis shows combined results, for all studies, of a 2.6x success rate for EVIE when compared to standard bolus IUI, for woman under 35 years.  A further meta analysis of the RSL European data, the Fertiligent data and Muharib data will follow at the beginning of 2018.  This is significant, as the combined data show statistically significant superiority over the standard method in women under 37 years. 

Unpublished, preliminary consolidated data

Preliminary consolidated results from three trials conducted in 13 centres in Europe and Israel.

The two pilot studies conducted by Fertiligent and the recently closed Reproductive Sciences Limited (RSL) European study.

Only data for <35 years of age included in this analysis.

33 inseminations were analysed from the Fertiligent study and 172 from the RSL study, giving a total of 205.

The median age of the Fertiligent study group (<35yrs) was 30 yrs with a range of 23-34 years (IQR=26.5 to 32).

There was no statistically significant difference in the distribution of ages between the RSL and Fertiligent groups.

Treatment outcomes

Overall, 7.2% of inseminations resulted in pregnancy for the IUI method, compared to 18.5% for SRI

This gives a relative risk (RR) of 2.566 (p=0.012).

There is therefore a statistically significant advantage of SRI over IUI in this age group.

 

 

EVIE improved success rates by 2.6x compared with standard IUI for women under 35 years old.

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