Fertility and sterility · 2025
Ovarian stimulation with follitropin delta is safe and effective: results from the RITA randomized, double-blind, placebo-controlled trials.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Scheiber Michael D, Doody Kevin J, Foster Eric D, Grover Sarah A, Heiser Patrick W, RITA-1 and RITA-2 (Recombinant FSH Investigation in the Treatment of Infertility with ART) trial groups
Аннотация
OBJECTIVE: To demonstrate the efficacy and safety of follitropin delta (recombinant follicle-stimulating hormone produced from the human cell line PER.C6) for ovarian stimulation in patients aged 18-34 and 35-42 years undergoing in vitro fertilization or intracytoplasmic sperm injection treatment in the United States.
DESIGN: Two randomized, double-blind, placebo-controlled, parallel-group, multicenter trials (RITA-1 and RITA-2).
SUBJECTS: A total of 1,165 patients (578 women aged 18-34 years in RITA-1 and 587 women aged 35-42 years in RITA-2), randomized 10:1 to follitropin delta or placebo.
INTERVENTION: Ovarian stimulation with follitropin delta at a fixed starting dose (12 μg/d for patients aged <35 years and 15 μg/d for patients aged ≥35 years) for the first 4 stimulation days and subsequent dose adjustments as needed, or placebo as a reference group, in a gonadotropin-releasing hormone antagonist cycle.
MAIN OUTCOME MEASURES: Cumulative ongoing pregnancy rate after fresh and cryopreserved cycles initiated within 12 months from start of ovarian stimulation.
RESULTS: The cumulative ongoing pregnancy rates with follitropin delta were 64.0% in patients aged <35 years (RITA-1) and 43.9% in patients aged ≥35 years (RITA-2) vs. 0 with placebo, thus establishing superiority of follitropin delta to placebo (RITA-1, difference, 64.0% [95% confidence interval, 56.9%-68.1%]; RITA-2, difference, 43.9% [95% confidence interval, 37.0%-48.2%]). The cumulative live birth rates with follitropin delta were 62.5% in patients aged <35 years and 42.4% in patients aged ≥35 years. In the fresh transfer cycle, the ongoing pregnancy rates with follitropin delta were 49.5% in patients aged <35 years and 34.8% in patients aged ≥35 years, and the live birth rates were 48.2% and 33.9%, respectively. In cryopreserved transfer cycles, the ongoing pregnancy rates with follitropin delta were 44.2% in patients aged <35 years and 31.2% in patients aged ≥35 years, and the live birth rates were 42.8% and 29.9%, respectively. The incidence rates of ovarian hyperstimulation syndrome in the fresh cycle were 3.8% in patients aged <35 years and 2.4% in patients aged ≥35 years after treatment with follitropin delta.
CONCLUSION: Follitropin delta, dosed on the basis of maternal age, is an effective and safe therapeutic for ovarian stimulation in in vitro fertilization/intracytoplasmic sperm injection patients.
TRIAL REGISTRATION: For RITA-1, NCT03740737 (ClinicalTrials.gov), registered on October 24, 2018, first subject enrolled on October 26, 2018. For RITA-2, NCT03738618 (ClinicalTrials.gov), registered on October 24, 2018, first subject enrolled on October 29, 2018.
DESIGN: Two randomized, double-blind, placebo-controlled, parallel-group, multicenter trials (RITA-1 and RITA-2).
SUBJECTS: A total of 1,165 patients (578 women aged 18-34 years in RITA-1 and 587 women aged 35-42 years in RITA-2), randomized 10:1 to follitropin delta or placebo.
INTERVENTION: Ovarian stimulation with follitropin delta at a fixed starting dose (12 μg/d for patients aged <35 years and 15 μg/d for patients aged ≥35 years) for the first 4 stimulation days and subsequent dose adjustments as needed, or placebo as a reference group, in a gonadotropin-releasing hormone antagonist cycle.
MAIN OUTCOME MEASURES: Cumulative ongoing pregnancy rate after fresh and cryopreserved cycles initiated within 12 months from start of ovarian stimulation.
RESULTS: The cumulative ongoing pregnancy rates with follitropin delta were 64.0% in patients aged <35 years (RITA-1) and 43.9% in patients aged ≥35 years (RITA-2) vs. 0 with placebo, thus establishing superiority of follitropin delta to placebo (RITA-1, difference, 64.0% [95% confidence interval, 56.9%-68.1%]; RITA-2, difference, 43.9% [95% confidence interval, 37.0%-48.2%]). The cumulative live birth rates with follitropin delta were 62.5% in patients aged <35 years and 42.4% in patients aged ≥35 years. In the fresh transfer cycle, the ongoing pregnancy rates with follitropin delta were 49.5% in patients aged <35 years and 34.8% in patients aged ≥35 years, and the live birth rates were 48.2% and 33.9%, respectively. In cryopreserved transfer cycles, the ongoing pregnancy rates with follitropin delta were 44.2% in patients aged <35 years and 31.2% in patients aged ≥35 years, and the live birth rates were 42.8% and 29.9%, respectively. The incidence rates of ovarian hyperstimulation syndrome in the fresh cycle were 3.8% in patients aged <35 years and 2.4% in patients aged ≥35 years after treatment with follitropin delta.
CONCLUSION: Follitropin delta, dosed on the basis of maternal age, is an effective and safe therapeutic for ovarian stimulation in in vitro fertilization/intracytoplasmic sperm injection patients.
TRIAL REGISTRATION: For RITA-1, NCT03740737 (ClinicalTrials.gov), registered on October 24, 2018, first subject enrolled on October 26, 2018. For RITA-2, NCT03738618 (ClinicalTrials.gov), registered on October 24, 2018, first subject enrolled on October 29, 2018.