The exogenous progesterone-free luteal phase: two pilot randomized controlled trials in IVF patients.

Abstract

RESEARCH QUESTION\nIs the reproductive outcome similar after gonadotrophin-releasing hormone agonist (GnRHa) trigger followed by luteal human chorionic gonadotrophin (HCG) boluses compared with HCG trigger and a standard luteal phase support (LPS)?\n\n\nDESIGN\nTwo open-label pilot randomized controlled trials (RCT) with 250 patients from 2014 to 2019, with a primary outcome of ongoing pregnancy per embryo transfer. Patients with ≤13 follicles on the trigger day were randomized (RCT 1) to: Group A (n\u202f=\u202f65): GnRHa trigger followed by a bolus of 1500\xa0IU HCG s.c. on the oocyte retrieval day (ORD) and 1000\xa0IU HCG s.c. 4 days later, and no vaginal LPS; or Group B (n\u202f=\u202f65): 6500\xa0IU HCG trigger, followed by a standard vaginal progesterone LPS. Patients with 14-25 follicles on the trigger day were randomized (RCT 2) to Group C (n\u202f=\u202f60): GnRHa trigger followed by 1000\xa0IU HCG s.c. on ORD and 500\xa0IU HCG s.c. 4 days later, and no vaginal LPS; or Group D (n\u202f=\u202f60): 6500\xa0IU HCG trigger and a standard vaginal LPS.\n\n\nRESULTS\nIn RCT 1, the ongoing pregnancy rate was 44% (22/50) in the GnRHa group versus 46% (25/54) in the HCG trigger group (RR 0.95, 95% CI 0.62-1.45). No ovarian hyperstimulation syndrome (OHSS) was seen in Groups A or B. In RCT 2, the ongoing pregnancy rate was 51% (25/49) in the GnRHa group versus 60% (31/52) in the HCG trigger group (RR 0.86, 95% CI 0.60-1.22). The OHSS rates were 3.3% and 6.7%, respectively.\n\n\nCONCLUSIONS\nAlthough a larger-scale study is needed before standard clinical implementation, the present study supports that the exogenous progesterone-free LPS is efficacious, simple and patient-friendly.