ABSTRACT
OBJECTIVE: The last year has represented a challenging time for andrology laboratories due to the COVID-19 pandemic. Public health guidelines and government regulations intended to reduce the spread of COVID-19 caused a shift in patient practices across healthcare. They impacted the infertility laboratory by changing where and how semen samples are collected. The current study compared the quality of semen being collected for routine semen analysis (SA), and therapeutic IUI cycles, comparing the first year of the pandemic with the previous twelve-month period in a regional fertility center. MATERIALS AND METHODS: Institutional rules, public health guidelines, and government regulations required the majority (> 98%) of semen samples collected at a regional fertility center to be collected off-site starting March 18th, 2020. The center serves a catchment basin of approximately 300 miles in diameter, meaning some patients might travel for 1-2 hrs to deliver samples collected at home or have to make other arrangements for a collection location closer to the laboratory. To determine what impact the delay in processing and other factors, such as stress, might be having on semen quality, the center conducted a study comparing the standard semen parameters in two arms. The COVID-19 arm were patients seen from March 18th, 2020 to March 17th, 2021, and they were compared to the Pre-COVID-19 arm, who were seen from March 18th, 2019 to March 17th, 2020. Semen Analysis parameters analyzed for all samples included volume, concentration/mL, motility, morphology, total concentration, and total motile concentration. IUI samples were also analyzed for post-wash total concentration and total motile concentration. Resulting Data were compared using student's T-test. RESULTS: A total of 423 SA and 378 IUI records were compared. As expected, off-site collection significantly increased the time from collection to completion of the procedure (P < 0.001). Numerous semen parameters of the standard semen analysis were 10-20% lower in the pandemic year when collecting off-site than the same parameter in the 12 months before the pandemic when on-site collection was used. Focusing on IUI data, the average processing time from collection to finish increased 26 to 48 mins (p < 0.006). Average Total motile sperm has decreased from 49 to 42 million (14%;P < 0.05) between groups. Pregnancy data is pending. CONCLUSIONS: The pandemic has presented challenges to all reproductive centers. The challenges appear to have had a negative effect on the overall semen quality of patients. While it is unclear how much of an impact delays in processing are having, the data is highly suggestive they are impacting patient treatment. IMPACT STATEMENT: While delivery of reproductive health care continued during the pandemic, changes in public health guidelines and governmental regulations have impacted patient care thereby causing a reduction in semen quality. Public health officials and practices may need to reevaluate how semen samples are collected for diagnostics and treatment to mitigate this reduction in quality while maintaining the overall health of patients and staff.
ABSTRACT
Objective: The last twelve months have presented significant challenges for the ART laboratory. Mandatory shutdowns, lack of patient access, supply chain issues, and changing rules and recommendations brought on by COVID-19 have stretched laboratories to their limits in an attempt to maintain regular and required activities. One area of concern in the laboratory has been the lack of available fresh semen (FS) samples at the proper times for quality control (QC) and proficiency testing (PT). Cryopreserved semen (CS) would appear a reasonable alternative. However, the quality of CS is known to deteriorate much faster than FS, even in favorable culture conditions. The goal of the present study was to determine, given the limitations of CS samples, if a protocol could be developed for QC and PT testing using CS. Materials and Methods: Using materials of known quality from previous PT challenges, 7 commercial donor semen samples were thawed and prepared for quality control monitoring as follows. Samples were thawed using bank-specific protocols. Each thawed sample was split in half and prepared using an IUI wash protocol with the assigned PT challenge media, either tainted or un-tainted. Once prepared, samples were maintained at 37oC, room air, and 95% relative humidity. Starting at 0 hrs, the samples underwent a semen analysis hourly using an IVOS semen analyzer for a minimum of 6 hrs or until one sample in the pair reached 0% motility after the 6 hr time-point. The resulting data were compared using a paired student’s T-test. Further, results were compared with reports from laboratory PT to verify the efficacy of using frozen semen. Results: As expected semen parameters decreased over time regardless of treatment (P < 0.001). No pair of samples lasted more than seven hours of incubation. While sperm in the non-tainted media maintained at least 60% of its initial motility at 3 hrs (range 64-91%), none of the cells in the tainted media had more than 50% motility at that time point (range 12-43%;p < 0.001). Further by six hours, all but one of the seven samples in the tainted media had 0% motility (range 0-4%), while six of seven samples in the non-tainted media still maintained a minimum of 25% of their initial motility at thaw (22-37%: P < 0.001). Further, all samples correlated with previous PT results. Conclusions: The data suggest it is possible to perform a rapid sperm QC assay using CS. Having a secondary QC protocol would not only provide an alternative when fresh semen, mice embryos, or other methods are unavailable, it would also potentially allow for more standardized methods of QC and PT testing. Impact Statement: The past twelve months have taught that unexpected and uncontrollable events can disrupt routine procedures. Sperm QC assays, which are the mainstay for QC and PT in many andrology laboratories, are dependent on the availability of fresh semen. If a standardized CS method can be created, QC and PT could be done at the convenience of the lab without sacrificing quality or patient safety.