Abstract
Abstract Study question Is the association of follitropin delta and menotropin similar than follitropin alpha and menotropin in controlled ovarian stimulation in assisted reproduction treatment? Summary answer Both drug associations were similar in terms of the number of follicles, retrieved eggs, mature eggs, blastocysts, and pregnancy rates. What is known already Controlled ovarian stimulation (COS) is one of the fundamental steps of assisted reproduction (AR). Currently, there are numerous protocols in order to maximize stimulation results. Among the most used regimens, are those using recombinant FSH associated with human menopausal gonadotropin (hMG). Recently, a new recombinant gonadotropin called follitropin delta (Rekovelle®) was launched, with a large controlled, multicenter international study showing that this formulation is not inferior to follitropin alfa (Gonal-F®), which has been used as a benchmark. However, to date, little is known about the efficacy of follitropin delta associated with hMG compared to follitropin alfa in a similar combination. Study design, size, duration Retrospective case-control study evaluating 624 patients and 731 cycles of ovarian stimulation from a private assisted reproduction clinic between January 2020 and July 2021. Participants/materials, setting, methods The study group, composed of 337 cycles of women who used follitropin delta (Rekovelle®) + menotropin (Menopur®), named DG, was compared to the control group, composed of 394 cycles of women who usedfollitropin alfa (Gonal-F®) + menotropin (Menopur®), named AG. The correspondent dose of 225 UI and 150UI of follitropin alfa was 12 ng/ml and 8 ng/ml of follitropin delta respectively. Main results and the role of chance A total of 731 cycles were analyzed in this phase. Results were adjusted for age, anti-mullerian hormone (AMH), and reason for treatment. Demographics and total dose used were not significantly different between groups. The mean number of follicles was 11,92(6,73) on the DG against 12,76(6,65) on AG p = 0,05. The number of oocytes and mature oocytes retrieved was higher in the DG but with no significance, 10,64(8,20) vs 10,49(7,66), p = 0,61, and 8,19(6,40) vs 8,02(5,89), p = 0,61, respectively. The number of total blastocysts was 2,05(3,28) on the DG vs 2,19(3,06) on the AG (p = 0,97) and the number of top-quality blastocysts was 0,97(1,86) on the DG group and 1,04(1,81) on the AG (p = 0,94). Regarding the euploidy rate, the DG had a 26,02%(31,08) against 21,31%(32,05) for the AG (p = 0,34). The implantation rate was slightly higher on the AG, 26,09%(42,29) vs 16,67%(36,19) but with no significance (p = 0,62). When analyzing the pregnancy rate, the rate was higher on the DG although it was not significant 53,13(119,58) vs 48,03(48,61), p = 0,08. Limitations, reasons for caution This is a non-controlled, retrospective study Wider implications of the findings The combination of follitropin delta and menotropin is an alternative for COS. As well, the dose of 8cmg of follitropin delta is equivalent to 150UI of follitropin alpha in the association with 150UI HMG. The same way, 12mcg was equivalent to 225UI. Both results were different from previously publish data. Trial registration number 40457620.2.0000.5474
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