The exogenous progesterone-free luteal phase: two pilot randomized controlled trials in IVF patients. Issue 6 (June 2021)

• Record Type: Journal Article
• Authors: Humaidan, Peter; Alsbjerg, Birgit; Elbaek, Helle Olesen; Povlsen, Betina Boel; Laursen, Rita Jakubcionyte; Jensen, Mette Brix; Mikkelsen, Alice Toft; Thomsen, Lise Haaber; Kol, Shahar; Haahr, Thor
• Is Part Of: Reproductive biomedicine online. Volume 42:Issue 6(2021)
• Page Start: 1108
• Page End: 1118
• Publication Date: 2021-06
• Subjects: GnRH agonist trigger -- HCG -- IVF -- Luteal phase support -- Ovarian hyperstimulation syndrome -- Progesterone; Human reproductive technology -- Periodicals; Human embryo -- Periodicals; Reproduction -- Periodicals; 616.692
• DOI: 10.1016/j.rbmo.2021.03.011
• Languages: English
• ISSNs: 1472-6483

Abstract

Highlights: Vaginal luteal phase support is inconvenient, mainly due to vaginal leakage. An RCT exploring the exogenous progesterone-free HCG-based luteal phase support. Two small HCG boluses for LPS replace exogenous vaginal progesterone. The exogenous progesterone-free LPS is efficacious, simple and patient-friendly. Abstract: Research question: Is 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)? Design: Two 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 = 65): GnRHa trigger followed by a bolus of 1500 IU HCG s.c. on the oocyte retrieval day (ORD) and 1000 IU HCG s.c. 4 days later, and no vaginal LPS; or Group B ( n = 65): 6500 IU 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 = 60): GnRHa trigger followed by 1000 IU HCG s.c. on ORD and 500 IU HCG s.c. 4 days later, and no vaginal LPS; or Group D ( n = 60): 6500 IU HCG trigger and a standard vaginal LPS. Results: In 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. Conclusions: Although 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.