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Background and Aims: Kisspeptin is an emerging biomarker for the discrimination of viable pregnancy. The aim of the study is to determine whether serum kisspeptin can predict the first trimester miscarriage and compare it with serum hCG in the prediction of the first trimester miscarriage. Method: This study is a prospective case-control design including 178 women who had experienced early miscarriage (n = 21) and viable single pregnancy (n = 157), following frozen-thawed transfer (FET) from May 2019 to December 2019. Serum samples on 14 days, 21 days and 28 days after FET were collected for kisspeptin and hCG detection. Trial registration number: NCT03940495 Results: On day 21 after FET, serum kisspeptin levels were significantly lower in the early miscarriage group [0.260(0.185-0.375)] vs in the viable single pregnancy group [0.370(0.280–0.495)] (p=0.005). Similar results were showed on day 28 after FET, the serum kisspeptin levels were significantly lower in the early miscarriage group [0.27(0.2–0.33)] vs in the viable single pregnancy group [0.670(0.455–1.235)] (p<0.001). But on day 14 after FET, serum kisspeptin levels were comparable in the early miscarriage group [0.260(0.210–0.325)] and in the viable single pregnancy group [0.280(0.215–0.340)] (p=0.551). Serum kisspeptin levels on day 21 and 28 have a poor predictive value of miscarriage compared with serum hCG levels. [Day 21: area under the curve = 0.687 (kisspeptin) and 0.816 (hCG); Day 28: area under the curve = 0.896 (kisspeptin) and 0.909 (hCG)]. Conclusion: Serum kisspeptin on day 14 failed to discriminate between miscarriage and ongoing pregnancies, and on day 21, 28 has a poor predictive value of miscarriage. Funding: This study was supported by the Special Project for Clinical Research in the Health Industry of the Shanghai Municipal Health Commission (20194Y0036).