Comparative Evaluation of Indigenous and Commercial ICSI Culture Media: A Pre-Clinical Study

Abstract

Background: Optimizing embryo culture conditions is essential for successful Intracytoplasmic sperm injection (ICSI). In India, several commercial culture media—such as Vitrolife, Vitromed, Cook Medical, Origio, and Sage—are widely used. However, their high costs and dependence on international supply chains limit accessibility in resource-constrained settings. The development of indigenous embryo culture media offers a promising and cost-effective alternative; however, robust comparative evidence is required to establish their efficacy and safety. Our study is the first in India to provide systematic pre-clinical validation of a locally formulated ICSI culture media under standardized laboratory conditions. Objective: To systematically compare embryological outcomes between a novel indigenous IVF culture media and the commercially available culture media in an Indian population undergoing intracytoplasmic sperm injection (ICSI) cycles. Methods: This prospective, randomized comparative study was conducted at Medical Health and Research Institute, Hyderabad, India from April 2024 to September 2025. A total of 72 women (aged 25 - 37 years) with primary or secondary infertility were enrolled. Participants were matched for baseline characteristics and randomized to receive either the indigenous or commercially available culture media. All underwent standardized ovarian stimulation, oocyte retrieval, and fertilization (ICSI). Embryos were cultured to the blastocyst stage in their assigned media. Laboratory outcomes included fertilization (2PN), cleavage, good-quality embryos (day 3), blastocyst formation, and cryopreservation eligibility. Clinical outcomes assessed were implantation, clinical pregnancy, ongoing pregnancy, miscarriage, and live birth rates. Cumulative outcomes from both fresh and frozen transfers were also analyzed. Statistical significance was set at p < 0.05. Results: Baseline characteristics, stimulation parameters, and oocyte yields were comparable between groups. Fertilization, cleavage, and blastocyst formation rates were comparable with commercially available culture media (92%, 93%, 58%) compared to the indigenous media (89%, 91%, 52%), though not statistically significant. Rates of high-quality embryos and cryopreserved blastocysts were similar. Clinical outcomes—including pregnancy commercially available culture media 48% vs. indigenous (45%), ongoing pregnancy (44% vs. 41%), and live birth rates (40% vs. 38%)—were also comparable. Miscarriage and multiple pregnancy rates showed no significant differences between the groups. Conclusion: The indigenous embryo culture media supported fertilization, embryo development, and clinical pregnancy outcomes at levels equivalent to commercially available culture media. These results suggest that indigenously developed media represent a clinically viable, accessible, and cost-effective alternative to proprietary products for IVF laboratories in resource-limited environments. This has substantial implications for expanding equitable ART access in India and similar settings, without compromising reproductive success.