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Abstract Study question Does an increased FSH dosage result in higher cumulative live birth rates in advanced age women with poor ovarian reserve treated with IVF or ICSI? Summary answer In poor ovarian reserve women, FSH dose of 300 IU/day does not improve cumulative live birth rates as compared to 150 IU/day. What is known already Natural fecundity and pregnancy rate following ART decrease dramatically in women aged 35 years and above. An open-label multicenter RCT described no difference in the cumulative live birth rate between the increased FSH dose (225/450 IU/day) and standard dose (150 IU/day) in women with a predicted poor ovarian response. Nevertheless, it is still unclear whether advanced age women with poor ovarian reserve who are undergoing IVF/ICSI benefit from a higher gonadotrophin dose. Therefore, we aimed to assess whether rFSH 300 IU/day compared to 150 IU/day in advanced age women with poor ovarian reserve resulted in higher cumulative live birth rates. Study design, size, duration A single center prospective randomized controlled trail that included first in vitro fertilization cycle with a GnRH-ant protocol and subsequent fresh and frozen-thawed cycles from April 2019 to December 2022. The study group included 104 women that received rFSH 150 IU/day and 99 women received rFSH 300 IU/day in antagonist protocol. Participants/materials, setting, methods Women for their first stimulation cycle, aged 35 to 42 years with antral follicle count（AFC）≤ 5 or anti-mullerian hormone （AMH） ≤ 1.2 ng/ml were randomized. Study group and control group respectively received 300 IU and 150 IU rFSH from menstrual cycle day 2 or 3 till the day of trigger. The primary outcome was cumulative live birth rate per woman per stimulation over a 2-year period to account for the first live birth. Main results and the role of chance This study included 203 women with the GnRH antagonist protocol. Of them, 99 patients were in 300 IU/day rFSH group, and 104 patients were in 150 IU/day rFSH group, respectively. The two groups were comparable for all baseline characteristics. The cumulative live birth rate for increased rFSH dosing (300 IU) versus standard dosing (150 IU) was 13.13% (13/99) versus 25% (26/104) per stimulation cycle. (P = 0.049). There were no differences in cumulative pregnancy rates 27.27% (27/99) vs 35.58% (37/104) per stimulation cycle. (P = 0.262). The cumulative live birth rate and cumulative pregnancy rates per transfer cycle in 300 IU/day rFSH group vs 150 IU/day rFSH group presented no statistical difference. No significant difference was found in secondary outcomes including time to live birth, number of MII oocytes, number of transferable embryos, implantation rate, multiple pregnancy rate, ectopic pregnancy rate and miscarriage rate between the two groups. Limitations, reasons for caution As this study is open-label, potential selective cancelling of cycles in women could have influenced the cumulative results. Also, this study practiced in a single-center and specific patient population, the results may not be generalizable to a broader population. Wider implications of the findings In women 35 years or older with poor ovarian reserve, improving rFSH dosage to 300IU in GnRH-ant protocol did not improve cumulative live birth rate. rFSH 150IU/day may be recommended at the start of COS to achieve live birth outcomes while decrease costs. Trial registration number ’not applicable
Li et al. (Mon,) studied this question.