Nowadays, around 15 to 20% of couples are infertile and the rate is increasing every year. Despite the improvement of assisted reproductive technologies(ART) in the last decades, a group of patients, called poor responders, who cover from 9 to 24% of the entire infertile population(Ubaldi et al. 2005, Patrizio et al. 2015), has not an optimal response to conventional stimulation. The results in term of live birth delivery rate(LBDR) in this category of patients is low and heterogeneous, and it is approximately 3 to 20%. Recent introduction of Bologna criteria for the definition of poor responder should reduce the heterogeneity of the results. Different type of exogenous follicle-stimulating hormone (FSH)(urinary human menopausal gonadotropin(HMGs), highly purified(hp)-HMG, recombinant-FSH(rec-FSH)( folllitropin alfa/follitropin beta/folitropin delta), corifollitropin alfa) combined in different protocols(agonist/antagonist protocol, short/long protocol) are available nowadays but no one demonstrate a strong change in the prognosis of these women. One of the most recent drugs tested in poor responder was corifollitropin alfa, able to initiate and sustain multiple follicular growth for an entire week. The addition of hp-HMG to corifollitropin alfa has demonstrated a non-inferiority efficacy in term of LBDR compared with traditional drugs. However, hp-HMG, unlike to corifollitropin alfa, contained both FSH and luteinizing hormone(LH) activity.
Since it has been demonstrated that adding LH supplementation improve outcome in poor responder, we want to test the effectiveness in term of LBDR of hp-HMG alone started at the beginning of the stimulation versus the combination of corifollitropin alfa followed to hp-HMG. For our knowledge this is the first study compared these two type of controlled ovarian stimulation(COS) in poor responder in a fixed antagonist protocol.
Rate of infertility is growing up; poor responder cover from 9 to 24% of the entire infertile population, thus give a better chance to these women is a goal in scientific research. Actually, despite different treatment strategy available, no one can improve the chance to have a baby. Despite the introduction of new drugs, as corifollitropin alfa, is not still clear if there is an advantage in term of LBDR in poor responder women, using this drug in ART or if the traditional older drugs are more effective. In the natural cycle is well known that both FSH and LH hormone play a role in the follicles stimulation and maturation of the oocytes, thus applying both activity from the beginning of the stimulation could improve the outcome.
For our knowledge, this is the first study testing the difference in term of LBDR in poor responder women, treated with corifollitropin alfa followed to hp- HMG versus hp-HMG alone. The results of this study could add information in these very difficult category of patients.