Dual triggering of final oocyte maturation in poor ovarian responders: a prospective randomized controlled trial

Abstract

Women with POR (Bologna criteria) manifest a very low follicular response to controlled ovarian stimulation irrespective of the stimulation protocol utilized. Dual triggering of oocyte maturation was shown to improve follicle collection yield and oocyte maturation in women with predicted normal ovarian response. These benefits have been attributed to the GnRHa-induced FSH surge believed to promote oocyte nuclear maturation and cumulus expansion. The aim of the study is to show whether the co-administration of a GnRH agonist and hCG for final oocyte maturation improve oocyte collection and maturation rates in women with poor ovarian response (POR) compared with hCG alone. This is an ongoing prospective randomized controlled trial seeking to randomize 140 women with POR undergoing IVF/ICSI treatment into receiving a dual trigger for final oocyte maturation compared with conventional hCG, between May 2018 and December 2019. Women with POR (Bologna criteria) were randomized to receive either a combination of 0.3 mg Triptorelin subcutaneously (Decapeptyl; Ipsen Beaufour; Denmark) and 10,000 IU hCG subcutaneously (Choriomon; IPSA Pharmaceuticals; Switzerland) or 10,000 IU hCG alone. Primary outcomes were oocyte collection and maturation rates. Secondary outcomes were clinical and ongoing pregnancy rates. Chi Square analysis was utilized for categorical data and student t test for continuous variables. A p <0.05 was considered for statistical significance. Sixty-eight patients have been recruited to this point with a cycle cancelation of 7.35% (5/68). A total of 63 patients were randomly allocated to the dual trigger (n=28) and hCG alone (n=35) groups. Baseline demographic and stimulation characteristics were comparable between the two groups. The total number of oocytes (4 vs. 4.2; p=0.65), number of mature oocytes (3.1 vs. 3.2; p=0.81), and number of 2PN zygotes (2.6 vs. 2.2; p=0.32) were not significantly different between the dual trigger and hCG alone groups. The oocyte collection (62.5% vs. 64.6%; p=0.75) and oocyte maturation rates (77.5% vs. 76.2%; p=0.82) were also comparable. Per embryo transfer, the clinical pregnancy rate (15.2 vs. 12.6; p=0.96) and ongoing pregnancy rate (13.8 vs. 12.6; p=0.63) showed no statistical differences. There was no significant increase in oocyte collection or maturation rates following dual triggering of final oocyte maturation compared with hCG alone in women with POR. POR (Bologna criteria) represents a subgroup of women with a very poor pregnancy prognosis and also a very challenging fertility management. Although the preliminary findings of this trial do not seem to hold promises in favor of an improved outcome with dual triggering of oocyte maturation in this subgroup of women, conclusive evidence are expected only following completion of the recruitment period.