Growth Differentiation Factor – 8 (GDF-8) as a predictor of clinical pregnancy in GnRH-agonist ICSI cycles: A prospective Cohort Study.

Abstract Objective The objective of this study was to assess the reliability of serum GDF-8 as a predictor of clinical pregnancy after IVF-ET and to investigate the relationship between serum GDF-8 and P4 for more understanding the function of GDF-8 in controlling serum P4 during COS. Methods A prospective cohort study was conducted with 42 women who underwent ICSI-ET and were recruited from a single fertility center in Alexandria, Egypt, from May 2023 to January 2024. A conventional long agonist protocol was used, and the serum levels of P and GDF-8 were measured at different time points. Serum human GDF-8 ELISA kits were used in accordance with the manufacturer’s protocol. Results The GDF-8 and P4 serum levels on the hCG day showed a highly significant negative correlation, the GDF-8 and P4 serum levels 2 weeks after ET showed a highly statistically significant negative correlation (p < 0.001), and there was a highly significant positive correlation between a decline in GDF-8 and a rise in P4 serum levels (from the day of hCG day to the day of OPU). The GDF-8 level was ≥ 3.9 ng/ml on the day of hCG seems to be a sensitive predictor of pregnancy following ICSI-ET Conclusion During controlled ovarian stimulation, GDF-8 level exhibits a dynamic pattern in conjunction with serum progesterone level. High serum level of GDF-8 (> 3.9 ng/ml), followed by a decline in this level (by > 1.35 ng/ml) might be reliable predictor of pregnancy after ICSI-ET. Trial registration number: NCT06529627 (retrospectively registered on 31/07/2024).