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Набор по приглашению NCT06666933

Study of Time-restricted Eating (TRE) to Clinical Pregnancy Rate in PCOS Women With Glucose Metabolism Disorder Via IVF/ICSI

Без фазы С лечением PCOS Glucose Metabolism Disorder IVF Outcome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Time restricted eating, Metformin.
Кому может быть актуально
Состояния в реестре: PCOS, Glucose Metabolism Disorder, IVF Outcome. Базовые параметры: 20 лет — 38 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Study of Time-restricted Eating (TRE) to Clinical Pregnancy Rate Via IVF/ICSI in Women With PCOS and Glucose Metabolism Disorder: A Multicenter Randomized Controlled Trial (RCT)

Обзор

Investigate the effect and mechanism of time-restricted eating (TRE) on the clinical pregnancy rate in women with PCOS and glucose metabolism disorder via IVF/ ICSI.

Подробное описание

In this multicenter randomized controlled study, investigators plan to recruit 254 patients, aged 20-38, with PCOS and glucose metabolism disorder. PCOS diagnostic criteria based on Rotterdam 2003 criteria, glucose metabolism disorder are diagnosed by 1998 WHO diagnostic criteria, with HbA1c≤7%. Participants selected are overweight or obese (24Kg/m2 ≤ BMI ≤40Kg/m2), and are planned to start the 1st/ 2nd cycle of IVF/ ICSI.

Investigators divide these patients randomly into 2 groups (each group with 127 patients): metformin only group (control group) and TRE with metformin group. Every participant receives the specific treatment according to the group for at least 6 weeks. During the intervention period, follow-ups, blood chemistry tests and examinations are recorded every 2 weeks. After the intervention period, IVF/ ICSI is carried out. GnRH-agonist- or/and hCG-triggered is used for ovarian stimulation. Ovum retrieval will be carried out 34-36h after ovarian stimulation. Blood hCG is tested after 12-14 days after embryonic transfer. For patients with positive hCG, clinical pregnancy is confirmed by observing gestational sac via transvaginal ultrasound after 4-5 weeks.

Investigators compare the terminal pregnancy-related result and metabolic changes between 2 groups to determine the effect and the possible mechanisms of TRE on IVF/ ICSI clinical pregnancy rate of PCOS with glucose metabolism disorder patients.

Вмешательства

  • Поведенческое Time restricted eating
    TRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks
  • Препарат Metformin
    Taking metformin 1g bid po only for 6 weeks as control

Первичные конечные точки

  • Clinical pregnancy rate for the first embryo transfer [Срок оценки: 4-5 weeks after the IVF/ ICSI carried out at the end of the 6 weeks intervention]
Вторичные конечные точки (11)
  • Number of retrieved oocytes [Срок оценки: After the IVF/ ICSI carried out at the end of the 6 weeks intervention]
  • Implantation rate [Срок оценки: After the IVF/ ICSI carried out at the end of the 6 weeks intervention]
  • Abortion rate [Срок оценки: After the IVF/ ICSI carried out at the end of the 6 weeks intervention]
  • Number of good quality embryo [Срок оценки: After the IVF/ ICSI carried out at the end of the 6 weeks intervention]
  • Weight [Срок оценки: From enrollment to the end of treatment at 6 weeks]
  • Fat% [Срок оценки: From enrollment to the end of treatment at 6 weeks]
  • Lipid profile [Срок оценки: From enrollment to the end of treatment at 6 weeks]
  • Blood pressure [Срок оценки: From enrollment to the end of treatment at 6 weeks]
  • Sex hormone [Срок оценки: From enrollment to the end of treatment at 6 weeks]
  • OGTT [Срок оценки: From enrollment to the end of treatment at 6 weeks]
  • Insulin stimulation [Срок оценки: From enrollment to the end of treatment at 6 weeks]

Критерии участия

Критерии включения

  • Diagnosed with PCOS based on Rotterdam 2003 (all 3 criteria should be fulfilled);
  • Diagnosed with glucose metabolism disorder (IGT, IFG, IGT with IFG, T2DM) and HbA1c less than or equal to 7%;
  • Age 20-38;
  • Overweight or obese (24Kg/m2 ≤ BMI ≤40Kg/m2);
  • Indication for IVF/ ICSI (repeated ovarian stimulation failure/ Fallopian tube blockage/ male factor) and ready for the 1st/ 2nd cycle of IVF;
  • Cooperative to follow-ups and capable of reporting severe adverse event (SAE);
  • Completed informed consent.

Критерии исключения

  • Unilateral ovary resection;
  • Abnormal uterus cavity (congenital, chronic endometrium inflammation, polyps, adhesion, fibroids, etc);
  • Chromosomal abnormality (either maternal or paternal);
  • Recurrent abortion or recurrent failure of embryo transfer;
  • Metformin allergy/ intolerance;
  • Other serious or uncontrolled diseases (e.g. kidney insufficiency, infection, controlled hypertension, heart disease, etc);
  • Preimplantation genetic testing;
  • Other condition that may impact the results

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
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • RenJi Hospital Department of Endocrinology and Metabolism — Шанхай

Идентификаторы

NCT: NCT06666933 · LY2024-160

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗