Preliminary Clinical Outcomes in an IVF Program Using the ProteX Versus a Standard Specimen Cup for Semen Collection
Authors
Samuel Prien1, Zev Williams2, Eric Forman2.
- Reproductive Solutions, Dallas, TX.
- Columbia Center for Fertility, Columbia University, NY, NY.
Publications
American Association of Bioanalysts Conference – poster presentation.
Objective
The advent of ICSI has given rise to the concept that sperm need only intact DNA to complete the fertilization process. The role other semen parameters might play a role in later embryo development is more controversial. Recently, a new sperm collection device (ProteX), specifically designed to maximize the quality of samples used in clinical procedures, was introduced for semen collection. The following is the first report of outcomes from a large-scale study in an IVF setting.
Design
Retrospective cohort comparing outcomes of IVF from semen samples produced in the ProteX (NSCD) containing a measured amount of culture media vs. a standard specimen cup (SSC) without media.
Materials and Methods
A total of 1077 couples undergoing IVF used either a SSC or NSCD to collect their semen. Further, approximately 40% of the patients in each group produced their semen samples away from the clinic. Data collected included both partners’ ages, standard semen parameters, stimulation and fertilization results, and embryo outcomes. As 92% of the patients were involved in freeze-all protocols, the primary embryo outcome was the percentage of embryos cryopreserved as high-quality expanded blastocysts.
Results
Female partners ranged in age from 21-48, with means of 34.8 vs.35.4 (SSC vs. ProteX, respectively). In contrast, there were differences between the groups for method of ovarian stimulation. However, the majority of patients in each group were treated with Clomid or Letrozole (> 80%). Males’ ages were similar (36.7 vs. 36.8). However, men collecting in the ProteX had higher volumes (2.2 VS. 2.5 mL; P < 0.008), motile cells (48.3 vs 53.0 mil; P < 0.001) and total motile counts (73.0 vs 91.3; P < 0.005). While both groups had initial pregnancy rates of 12%, 90% of the pregnancies resulting from sperm collected in the ProteX continued to heartbeat versus 70% in the SSC (P < 0.02).
Conclusions
The female partners in the NSCD in-clinic arm had the highest average age (38.1; P < 0.02), and the lowest average number of oocytes recovered (10.9; P < 0.03). Male partners were of similar ages between groups. However, men producing in the NSCD device had higher initial counts and motility than men producing in the SSC (P < 0.001). In addition, while fertilization and usable blastocyst rates were similar between groups, there was an 11% higher blastocyst rate in the NSCD group (43.8% vs. 39.4%) when expressed as embryos frozen/oocyte fertilized (P < 0.04).
Funding
ProteX were provided by Reproductive Solutions.
Disclosures
Reproductive Solutions supplied all ProteX for use in this retrospective review. Samuel Prien is an inventor of the technology, a consultant to Reproductive Solutions, and a stockholder in Reproductive Solutions.
Figure 1
Design and Concept of the ProteX Device
Table 1
Demographic data and semen parameters from the review of 1077 ART cycles using the ProteX (N=462) or Standard Specimen Cup (SSC; N=615) for semen collection. Data with a P value of < 0.05 are considered statistically different.
Insights
Patients were given the option of collecting in the clinic or at home. Approximately 40% of patients in both groups selected the at-home option (35.9% ProteX vs. 43.7% SSC). TABLE 1 provides the demographic data from the male patients. These data were similar across all four groups (P = 0.16). Both device and location appeared to have an effect on initial motility (P < 0.001), initial concentration (P < 0.001), and final motility (P < 0.01), with samples collected in the clinic with ProteX showing the best results.
Table 2
Demographic data and cycle outcomes of 1077 women whose oocytes were fertilized with either semen collected in ProteX (N=462) or a Standard Specimen Cup (SSC; N=615). Data with a P value of < 0.05 are considered statistically different.
Figure 2
A comparison of the number of embryos frozen/oocyte fertilized based on both device semen was collected in (ProteX vs. a Standard Specimen Cup (SSC)) and location (in-clinic vs. at-home) where it was collected. Columns with different superscripts are statistically different at the P < 0.02 level.
Insights
TABLE 2 provides the demographic and the retrieval/oocyte development data for the female partner. Couples using the ProteX in the clinic appeared to have significantly older female partners (P < 0.02) who produced significantly fewer oocytes (P < 0.03) but who had similar numbers of oocytes fertilized and blastocysts selected for storage (P = 0.31).
While the number of blastocysts frozen was similar in each group (TABLE 2; P = 0.31). If one expressed the number of blastocysts frozen as a percentage of oocytes fertilized, a higher percentage of embryos were being frozen from the patients who used the ProteX device (FIGURE 2; P < 0.02)
Figure 3
Early Pregnancy outcome of an IVF study comparing the ProteX to the Standard Specimen Cup (SSC) for semen collection. Fresh transfers (n=97) comparing the ProteX (N=38) to the Standard Specimen Cup (SSC; N=59) for semen collection. Columns within an event (pregnancy test, sac development, heartbeat) with different superscripts are different at the P < 0.02 level.
Insights
TABLE 2 provides the demographic and the retrieval/oocyte development data for the female partner. Couples using the ProteX in the clinic appeared to have significantly older female partners (P < 0.02) who produced significantly fewer oocytes (P < 0.03) but who had similar numbers of oocytes fertilized and blastocysts selected for storage (P = 0.31).
While the number of blastocysts frozen was similar in each group (TABLE 2; P = 0.31). If one expressed the number of blastocysts frozen as a percentage of oocytes fertilized, a higher percentage of embryos were being frozen from the patients who used the ProteX device (FIGURE 2; P < 0.02)
Figure 4
% Embryos Frozen/Embryos Fertilized by Female Partner Age and Site of Collection
- Difference in # Embryos frozen and female age p<0.001
- Difference in # Embryos frozen and sperm collection site p<0.001
- Difference in # Embryos frozen and collection device p<0.04
Table 3
Number of Patient Per Age Group/Site of Collection/Device
Direct insights into the research, methodology, and results have been added to this summary by the co-inventors themselves. This additional information is intended to provide helpful context to professional practitioners and does not fundamentally change the outcomes or interpretation of the published results. All ProteX research content and material is the property of Reproductive Solutions and may not be redistributed or republished without our consent. All rights reserved.
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