Abstract
Abstract Study question Can an alternative process for freezing semen be utilized for patients in need of fertility care during the coronavirus disease 2019 (COVID-19) pandemic travel restrictions? Summary answer At-home sperm freezing was developed during COVID-19 to offer fertility care for travel restricted patients, which provided similar IVF outcomes compared to laboratory frozen sperm. What is known already Cases of COVID-19 were first detected in December 2019 spreading rapidly across the world leading to declaration of a pandemic on March 11, 2020 and resulting in international border closures and global travel restrictions lasting into 2023. Sperm freezing by trained laboratory personnel is well established and safe clinical practice. While home semen collection kits existed to extend sperm survival for hours allowing sufficient time for the sample to reach facility to be frozen in the laboratory, there were no home semen freezing methods for longer time constraints available for our patients. Study design, size, duration A specialized home semen freezing process has been developed and validated in-house on research samples. Retrospective analysis was performed to assess home sperm freezing efficiency in patients undergoing fertility treatment. IVF outcomes were compared between home sperm freezing to the samples frozen in our laboratory (control) from 2020 to 2023. Participants/materials, setting, methods In total 508 semen samples frozen at home have been received at the clinic, with 495 (98%) of samples arriving within set time of 18 days in optimal frozen condition. Delivery of 12 samples were delayed causing sample thawing during transportation that required a new at home freezing. Only IVF with ova donors were included to compare outcomes of 448 IVF with semen frozen at home to 421 IVF with semen frozen in the laboratory. Main results and the role of chance Only 17 (3%) of home semen samples arrived from patients within Canada, while 491 (97%) were from patients of 27 different countries of several regions: Europe 346 (68%), Australia 73 (15%), Middle East 36 (7%), USA 26 (5%), Asia 7 (1.5%), and Latin America 3 (0.5%). Men from the study group were similar to control in terms of age (36 ± 5.2 versus 36.8 ± 5.8). Post thaw test was performed on all home freezing samples as a quality control to ensure that sufficient sample was available for IVF: mean sperm concentration was 25.3 M/ml ± 14.8 and motility of 21% ± 10. IVF outcomes between samples frozen at home or in the lab were compared; fertilization (80.3% ± 14.6 v. 79.6 ± 19.3), blastulation (66.5% ± 20.7 v. 66.6% ± 19.3%), clinical pregnancy (39.1% v. 38.8%), miscarriage (14.6% v.6.7%) or life birth (30.9% v. 31.6%), respectively, were not statistically different. PGT-A was performed on 7224 blastocysts with results controlled by the age of ova donors and were not statistically different for embryos derived from sperm frozen at home and in the laboratory with euploidy (65.3% v. 64.6%), mosaic (14.8% v.13.8%) and aneuploidy (19.9% v. 21.6%), respectively. Limitations, reasons for caution Pre-freezing semen analysis was only available for laboratory frozen samples. Post-thaw results were not compared between home and laboratory frozen sample as different freezing protocols with two dilution factor (1:1 v. 3:1) and different sample volume per frozen unit (0.1-1.2 ml in vial v. 0.5 ml in straw) were used. Wider implications of the findings In cases where it is logistically difficult or impossible for sperm providers to travel to the clinic for IVF treatment, home semen freezing performed by the patient is a viable and safe method. Trial registration number not applicable
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