Effects of GLP-1RAs on Reproductive Outcomes in PCOS and Obesity

Официальное название

Effects of GLP-1 Receptor Agonists Combined with Metformin and Healthy Lifestyle Education Prior to Fertility Treatment on Reproductive Outcomes in Women with PCOS and Obesity

Обзор

The goal of this clinical trial is to examine whether benalutide combined with metformin and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education.

Подробное описание

Benalutide, a short-acting recombinant human GLP-1RAs with nearly 100% homology to human GLP-1, has been approved by the Chinese National Medical Products Administration for treating weight loss in individuals with obesity. Up to now, there is a paucity of research on the potential impact of GLP-1RAs on reproductive, maternal and perinatal outcomes in women with PCOS and obesity undergoing fertility treatment. Given its effectiveness as a weight loss medication, benalutide theoretically holds promise for enhancing reproductive outcomes in women with PCOS and obesity prior to fertility treatment by facilitating weight reduction.

Вмешательства

• Препарат GLP-1 receptor agonist
  3 months
• Препарат Metformin
  3 months
• Поведенческое healthy lifestyle education
  3 months

Первичные конечные точки

• Live birth rate [Срок оценки: 18 months]

Вторичные конечные точки (12)

• BMI change from baseline to the 3rd month in kg/m2 [Срок оценки: 3 months]
• Spontaneous resumption of ovulation [Срок оценки: 3 months]
• Clinical pregnancy [Срок оценки: 9 months]
• Ongoing pregnancy [Срок оценки: 11 months]
• Pregnancy loss [Срок оценки: 18 months]
• Gestational age at delivery [Срок оценки: 18 months]
• Time to pregnancy leading to live birth [Срок оценки: 18 months]
• Hypertensive disorders of pregnancy [Срок оценки: 18 months]
• Gestational diabetes [Срок оценки: 18 months]
• Birth weight in kg [Срок оценки: 18 months]
• Neonatal mortality [Срок оценки: 18 months]
• Major congenital anomaly [Срок оценки: 18 months]

Критерии участия

Критерии включения

Women with a wish to conceive; Women with PCOS (Rotterdam criteria); 28 kg/m2≤BMI<35kg/m2;

Критерии исключения

Women with medical morbidity; Endocrine disorders; Abnormalities in liver and kidney function; Other medications such as glucocorticoids, anti-androgen drugs ;(spironolactone, cyproterone acetate, flutamide, etc.) within the last 3 months; Acute infections, severe cardiovascular disease, malignant tumors; Ongoing weight loss therapy (>5% weight loss in the last 3 months) or history of gastrointestinal surgery; Uterine anomalies or untreated tubal hydrosalpinx; Receiving a donor oocyte or donor sperm cycle; Chromosome abnormality or recurrent miscarriage; planning preimplantation genetic testing (PGT); Any other contraindications to fertility treatment; Allergic to or contraindicated for GLP-1 class medications.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT06775093 · M2024472

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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