背景:在第一个体外受精周期中,用于卵巢刺激的follitropindelta的最大日剂量为12μg(180IU),根据制造商开发的算法,并基于患者的卵巢储备和体重。这项研究旨在评估150IU的促性腺激素联合follitropindelta是否可以改善血清抗苗勒管激素水平低于2.1ng/mL的女性对刺激的反应。
方法:该研究包括一个前瞻性干预组,其中44名妇女从刺激开始就接受了12μg的叶酸δ和150IU的胰岛素样激素,另一个回顾性对照组为297名妇女,在该药物的3期研究期间仅接受了12μg的叶酸δ。两组的纳入和排除标准以及其他治疗和随访方案相似。通过施用促性腺激素释放激素(GnRH)拮抗剂来实现垂体抑制。根据发生卵巢过度刺激综合征的风险,使用人绒毛膜促性腺激素或GnRH激动剂触发排卵,并选择转移新鲜胚胎或使用冷冻全部策略。
结果:接受follitrocindelta联合促性腺激素的女性在触发日的雌二醇水平较高(2150pg/mL与1373pg/mL,p<0.001),更多胚泡(3.1vs.2.4,p=0.003)和更高质量的胚泡(1.8vs.1.3,p=0.017)。在怀孕期间没有观察到差异,植入,流产,和第一次胚胎移植后的活产率。两组之间卵巢过度刺激综合征的发生率没有差异。然而,在使用两种药物的组中,该综合征的预防措施比对照组更频繁(13.6%vs.0.6%,p<0.001)。
结论:在血清抗苗勒管激素水平低于2.1ng/mL的女性中,给予150IU的促性腺激素联合12μg的follitrocindelta改善了卵巢反应,在可以常规使用GnRH激动剂触发排卵和冷冻所有胚胎策略的情况下,使其成为有效的治疗选择。
背景:U1111-1247-3260(巴西临床试验注册,可在https://ensaiosclinicos.gov上获得。br/rg/RBR-2kmyfm)。
BACKGROUND: The maximum daily dose of follitropin delta for ovarian stimulation in the first in vitro fertilization cycle is 12 μg (180 IU), according to the algorithm developed by the manufacturer, and based on patient\'s ovarian reserve and weight. This study aimed to assess whether 150 IU of menotropin combined with follitropin delta improves the response to stimulation in women with serum antimullerian hormone levels less than 2.1 ng/mL.
METHODS: This study involved a prospective intervention group of 44 women who received 12 μg of follitropin delta combined with 150 IU of menotropin from the beginning of stimulation and a retrospective control group of 297 women who received 12 μg of follitropin delta alone during the phase 3 study of this drug. The inclusion and exclusion criteria and other treatment and follow-up protocols in the two groups were similar. The pituitary suppression was achieved by administering a gonadotropin-releasing hormone (GnRH) antagonist. Ovulation triggering with human chorionic gonadotropin or GnRH agonist and the option of transferring fresh embryos or using freeze-all strategy were made according to the risk of developing ovarian hyperstimulation syndrome.
RESULTS: Women who received follitropin delta combined with menotropin had higher estradiol levels on trigger day (2150 pg/mL vs. 1373 pg/mL, p < 0.001), more blastocysts (3.1 vs. 2.4, p = 0.003) and more top-quality blastocysts (1.8 vs. 1.3, p = 0.017). No difference was observed in pregnancy, implantation, miscarriage, and live birth rates after the first embryo transfer. The incidence of ovarian hyperstimulation syndrome did not differ between the groups. However, preventive measures for the syndrome were more frequent in the group using both drugs than in the control group (13.6% vs. 0.6%, p < 0.001).
CONCLUSIONS: In women with serum antimullerian hormone levels less than 2.1 ng/mL, the administration of 150 IU of menotropin combined with 12 μg of follitropin delta improved the ovarian response, making it a valid therapeutic option in situations where ovulation triggering with a GnRH agonist and freeze-all embryos strategy can be used routinely.
BACKGROUND: U1111-1247-3260 (Brazilian Register of Clinical Trials, available at https://ensaiosclinicos.gov.br/rg/RBR-2kmyfm ).