Case Studies
Over 800 Cases Of The INVOcell Treatment Have Been Documented With A Success Rate Comparable To That Of In-Vitro Fertilization
"This Procedure Can Be Performed
Right In Your Physician's Office"
Home I Privacy Policy I Terms Of Use I Contact Us
Summary of Clinical Experience
The intra vaginal culture (IVC/INVO) procedure, is an assisted reproductive technique (ART) acknowledged by the American Society for Reproductive Medicine (ASRM), which considers the procedure to be a variation of IVF (Letter dated July 27, 1993 from The American Fertility Society, now known as The American Society for Reproductive Medicine).
IVC/INVO was invented in 1985. Since then numerous peer-reviewed reports have been published detailing actual human clinical case results. This clinical experience, which is presented below, demonstrates that the IVC/INVO is a well-established, safe and effective procedure.
The IVC/INVO procedure has been used to treat patients with various causes of infertility including tubal factor, endometriosis, male factor and unexplained infertility. The method has been found to be effective in indications identical to those treatable by IVF, with the exception of very severe male factor where intra cytoplasmic sperm injection (ICSI) is recommended.
The INVOcell device has been ISO 10993 tested (and mouse embryos tested) to assess toxicity and biocompatibility. Clinical tests have been performed to evaluate the comfort and retention of INVOcell within the vagina. Preliminary analysis of a clinical trial performed in an infertile population has shown the INVOcell to be a well accepted, non traumatic, effective device with births of normal babies. Complete results from the clinical trial will be published in the future. This clinical trial also demonstrated that Complete P1 SSS could be used for 3 days of incubation without medium change.
Over 800 cases of IVC performed by infertility groups around the world (France, Germany, Netherlands, England, USA, Japan) and using a prototype have been documented in peer-reviewed journals, demonstrating success rates (average clinical pregnancy rate of 19.6% per cycle) which were comparable to success rates of conventional IVF.
The clinical pregnancy rate per cycle that went to oocyte retrieval was reported in most of the publications on IVC or could be easily calculated. We used this clinical pregnancy rate to allow pooling the results of all these different publications and calculate the average clinical pregnancy rate per cycle (19.6%) presented in Table I. When comparative studies were performed, pregnancy rates obtained by IVC were comparable to those observed in conventional IVF (Ranoux, and Seibel, 1990 & Sterzik et al, 1989).
Approximately 550,000 cycles of Intrauterine Insemination (IUI) are performed in Europe annually on 185,000 couples. IUI does not treat many indications of infertility such as endometriosis and non-patent tubes and only results in a 10% pregnancy rate per treatment cycle. Due to cost, many insurers require up to 3 treatment cycles to be performed per couple prior to receiving In-Vitro Fertilization (IVF) treatment that has an average pregnancy rate of 27%. The average cost of an IUI cycle in Europe is approximately $1,000 dollars per cycle vs. $5,000 dollars per cycle for IVF.
After 3 attempts to achieve pregnancy with IUI, approximately 25% or 45,800 couples will become pregnant leaving 137,500 couples untreated or referred to IVF. Patients that choose IVF go through an average of 2-3 cycles before becoming pregnant, with two cycles this is a cost of $10,000 per couple.
An analysis has been performed demonstrating effectiveness and cost of these two treatments, as well as INVO on the payment providers if the unsuccessful IUI couples have INVO provided when IUI fails as the next line of treatment or the initial treatment.
The total cost for the payment providers for IUI’s performed annually in Europe is approximately 550 million dollars per year with 550, 000 cycles at $1000 per cycle. The resulting pregnancy statistics of 10% per cycle and 25% per 3 cycles results in 45,833 pregnancies or $12,000 per pregnancy
The total cost for the payment providers for IVF treatment for the 137,500 couples who failed IUI, at 2 cycles per couple is approximately $1 .4 billion dollars per year at $10,000 per couple. The resulting pregnancy statistics of 27% per cycle and 47% per 2 cycles results in 64,390 pregnancies or $21,354 per pregnancy.
With the introduction of the INVO procedure, patients can receive INVO in their OB/GYN office or satellite IVF clinics at a cost of $2500 per cycle and a pregnancy rate of 20% per cycle and 36% per 2 cycles. With the INVO treatment of the failed 137,000 IUI couples, 49,500 pregnancies will result. The cost of INVO to the service provider will be $687 Million or $13,888 per cycle.
Conclusions: INVO can be provided as a cost effective treatment to treat the same wide infertility indications as IVF at a cost of $13,800 per pregnancy vs. $21,354 per pregnancy decreasing the annual total to the service providers by 50% from $1.375 Billion to $688 Million dollars
INVO can be provided as the first treatment to patients who have indications that are not treatable by IUI saving the providers the cost of unsuccessful IUI treatment resulting in further cost savings.
Notes:
1.
Efficacy rates taken from the European Society of Human Reproduction and Embryology (ESHRE)
Efficacy rates taken from the European Society of Human Reproduction and Embryology (ESHRE) report, 2003, published April 2007. 2.Costs taken from Oxford Human Reproduction Journals, IVF in Europe, European Medical Tourist and
Costs taken from Oxford Human Reproduction Journals, IVF in Europe, European Medical Tourist and Individual clinic website averages3.Number of cycles of IUI cycle extrapolated from 7 of the 32 European countries reporting 255,000 cycles
Number of cycles of IUI cycle extrapolated from 7 of the 32 European countries reporting 255,000 cycles Another publication on IVC by Costoya et al, 1991, is not reported in Table I. This publication concerned 23 cycles of which 18 proceeded to retrieval but could not be used, as only a fraction of the retrieved oocytes (78 on 102) were inseminated by IVC. The method for selecting these 78 oocytes was not defined. Costoya et al, 1991, achieved only an average 10.2% fertilization rate as other publications generally reported an average fertilization rates between 50.3% and 69.5 % for IVC. This abnormally low fertilization rate suggests a toxic factor, methodological problem or a wrong utilization of the prototype as suggested by 3 fertilized oocytes blocked at the pronuclei stage and 2 diagnosed contaminations of the culture medium by Candida albicans. On the 5 cleaved embryos transferred one birth was achieved, demonstrating the efficacy of the INVO technique when performed correctly
Clinical Benefits of IVC/INVO
The clinical reports discussed above also provide the practitioners’ perceived benefits of IVC. These benefits summarize in Table II include: 1. Psychological benefits associated with in vivo incubation of the gametes; 2. More physiologic conditions; 3. Saving technical time; 4. Reduced lab equipment need and costs; and 5. Fewer manipulations of the embryos due to automatic denuding in IVC instead of by hand.
