A randomized, non-inferiority trial on the DuoStim strategy in PGT-A cycles

Published:November 24, 2022DOI:


      Research Question

      The aim of our study was to confirm if more euploid embryos could be obtained using the DuoStim strategy, as well as to prove whether the first euploid embryo was obtained in a shorter amount of time.


      A prospective, randomized, controlled trial. This study was performed in IVI Madrid between June 2017 and Dec 2020. 80 suboptimal profile´s patients aged 38 or older undergoing PGT-A cycles. Patients were blindly randomized into two groups: 39 women underwent two ovarian stimulations in consecutive cycles (control group), whereas the double stimulation strategy was applied to 41 women (DuoStim group).
      The main outcome was the euploidy rate in each group. The secondary outcomes were the time it took to obtain a euploid embryo, the number of euploid embryos obtained in each stimulation, the days of stimulation and the total dose of gonadotropins, as well as the number of mature oocytes and the fertilization, blastocyst formation, pregnancy, miscarriage and live birth rates.


      The patients’ baseline characteristics were similar in both groups. We did not find differences between the control group and the DuoStim group in the total mean days of stimulation (21.3 ± 1.6 vs. 23 ± 1.4, p=0.105), total amount of gonadotropins required (4005 ± 450 vs. 4245 ± 430, p=0.43) or number of MII oocytes (8.7 ± 1.8 vs. 6.8 ± 1.7, p=0.159). The total number of blastocysts (2.1± 0.5 vs.1.5 ±0.6, p=0.04) and euploid embryos (0.8 ± 0.4 vs. 0.6 ± 0.4, p=0.45).
      The euploid rate per randomized patient (ITT) was 16.1%, in the control group and versus 22.7%, in the DuoStim group, with p-values of 0.371, and the euploidy rate per patient treated was 39.0%, with a 95% CI (26.5-51.4), in the control group, versus 45.7%, with a 95% CI (29.2-62.22), in the DuoStim group, resulting in a non-significant p-value=0.679138. However, there was a significant difference in the average number of days it took to obtain a euploid blastocyst, favoring the DuoStim group (44.1 ± 2 vs. 23.3 ± 2.8, p<0.001). Comparing the follicular phase to the luteal phase within the DuoStim group, the only difference detected concerns the mean days of stimulation (10.3 ± 0.8 vs. 12.7 ± 0.9, p<0.001). We also observed a trend towards higher fertilization (49.1% vs. 64.4%, p=0.03) and blastulation (24.1% vs. 46.1%, p=0.01) rates in the luteal phase of the DuoStim cycle, but there weren't statistical differences in the implantation (75% vs. 77%, p=0.63), pregnancy rates per transfer (60% vs. 66.7%, p=0.66), and live birth rate per transfer(59,0% vs. 66%, p=0.59) rates.


      The use of the DuoStim strategy in poor-prognosis patients undergoing PGT-A cycles maintains a similar euploidy rate while it shortens the time required to obtain a euploid blastocyst.



      PGT-A (Preimplantational Genetic Diagnosis-aneuploidies), IVF (in vitro fertilization ART, Assited reproductive Tecniques), FPS (Follicular phase stimulation), LPS (Luteal phase stimulation), COS (Controlled Ovarian Stimulation AFC, antral follicular count)
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      Dr Maria Cerrillo is an REI subspecialist working full time at IVI Madrid, Spain.  After her Obstetrics and Gynecology residency, obtained her Master in Reproductive Medicine and her PhD degree at Rey Juan Carlos Univerisity, Madrid, Spain.  Her main interests are ovarian stimulation protocols and reproductive surgery.