在体外受精周期中卵巢反应不良风险患者中，使用卵泡刺激素 δ 与促性腺激素联合治疗：一项前瞻性对照临床研究。
Follitropin delta combined with menotropin in patients at risk for poor ovarian response during in vitro fertilization cycles: a prospective controlled clinical study.
机构信息
Hospital Israelita Albert Einstein, São Paulo, Brazil.
Clínica VidaBemVinda, São Paulo, Brazil.
出版信息
Reprod Biol Endocrinol. 2024 Jan 2;22(1):7. doi: 10.1186/s12958-023-01172-9.
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.
TRIAL REGISTRATION
U1111-1247-3260 (Brazilian Register of Clinical Trials, available at https://ensaiosclinicos.gov.br/rg/RBR-2kmyfm ).
背景
根据制造商制定的算法，在第一个体外受精周期中，促卵泡激素 delta 的最大日剂量为 12μg（180IU），这是基于患者的卵巢储备和体重。本研究旨在评估在血清抗苗勒管激素水平低于 2.1ng/ml 的女性中，使用 150IU 人绝经期促性腺激素与促卵泡激素 delta 联合使用是否能改善对刺激的反应。
方法
本研究涉及一个前瞻性干预组的 44 名女性，她们从刺激开始时就接受了 12μg 的促卵泡激素 delta 联合 150IU 的人绝经期促性腺激素，以及一个回顾性对照组的 297 名女性，她们在该药物的第三阶段研究中单独接受了 12μg 的促卵泡激素 delta。两组的纳入和排除标准以及其他治疗和随访方案相似。通过使用促性腺激素释放激素（GnRH）拮抗剂实现垂体抑制。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 激动剂进行排卵触发，并选择转移新鲜胚胎或使用冷冻全部策略。
结果
接受促卵泡激素 delta 联合人绝经期促性腺激素治疗的女性在触发日的雌二醇水平更高（2150pg/ml 比 1373pg/ml，p<0.001），有更多的囊胚（3.1 比 2.4，p=0.003）和更多的优质囊胚（1.8 比 1.3，p=0.017）。两组在第一次胚胎移植后的妊娠、着床、流产和活产率方面没有差异。两组卵巢过度刺激综合征的发生率没有差异。然而，与对照组相比，使用两种药物的组中预防该综合征的措施更为频繁（13.6%比 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，使用 150IU 人绝经期促性腺激素联合 12μg 促卵泡激素 delta 可改善卵巢反应，这是一种有效的治疗选择，在常规使用 GnRH 激动剂触发排卵和冷冻全部胚胎策略的情况下。
试验注册
U1111-1247-3260（巴西临床试验注册处，可在 https://ensaiosclinicos.gov.br/rg/RBR-2kmyfm 获得）。
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