P-619 A prospective RCT comparing luteal phase treatment with estradiol and follicular antagonist for ovarian follicular synchronization in ICSI cycle in women with low ovarian reserve

Abstract

Study questionIn women with low reserve for ovarian follicular synchronization, luteal phase treatment with estradiol (LE) or follicular antagonist(FA) would offer better outcomes?Summary answerData concludes that priming protocols with FA seem to offer statistically significant blastulation rate with similar outcome for metaphase 11 and fertilization rate.What is known alreadyThe heterogenecity of follicular growth, particularly in women with low reserve, may cause decreased retrieval of mature oocytes and reduced blastocysts. Luteal estradiol and follicular anatagonist have been used as priming protocols for synchronizing follicles by suppressing endogenous FSH. This RCT intends to compare these two protocols, in terms of clinical outcome.Study design, size, durationThis is a Prospective RCT conducted between September 2020-December 2021 with prior approval from Institutional Ethical committee (ECR/1312/INST/TG/2019). Total number of subjects were 100. Women with poor response, defined based on POSEIDON criteria were randomized into LE (n = 50) and FA (n = 50) and recruited into the study protocol based on a computer generated randomization sheet.Exclusion criteria: Age>40Participants/materials, setting, methodsAfter randomization, all patients were started on Inj rFSH & Inj HP-HMG1. Estradiol valerate pre treatment armEstradiol dosage of 4mg/day, started 7 to 10 days before day 1 of the stimulation cycle.2. Follicular Antagonist armUltrasound performed on cycle day 1/2 to identify the absence of ovarian cyst or follicle >10mm. Pretreatment with Inj Cetrotide 0.25mg sc once day for 5-7 days,thereafter stimulation was started.All the subjects underwent Frozen Embryo replacement cycle .Main results and the role of chanceBaseline variables of patients were comparable between both arms. There was 1-dropout in FA arm due to covid -19 infection and no dropouts in LE arm. Hence a total of 49 patients in FA arm and 50 patients in LE arm were available for analysis.Total days of stimulation, total dose of FSH used ,number of oocytes retrieved, M11 rate, fertilization rate, blastulation rate, FSG/oocyte used were the primary outcomes.Implantation rate, ongoing pregnancy rate ,live birth rate were the secondary outcomesOutcomes between FA Vs LE were as followsDays of stimulation – 10.65 vs 10.10 (p = 0 .289)FSH dosage- 2654 vs 2360 (p = 0.730) Fertilization rate – 91% vs 80% (p = 0.48) Blastulation rate – 67% vs 40% (p = 0.006) All outcomes compared between the two arms seemed to be similar except follicular antagonist group that showed to have a higher blastulation rate compared to luteal estradiol group which was statistically significant.Limitations, reasons for cautionThe RCT was performed on a small sample size and should be confirmed on a larger cohort.Wider implications of the findingsThis study provides assuring data on using the two agents, with statistically significant blastulation rate in FA group. Furthur research on larger sample size is required .Trial registration number12