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Идёт набор NCT06863337

Glucose Pattern in Infertile Women Receiving Assisted Reproduction Using Continuous Glucose Monitoring

Без фазы С лечением Infertility Female

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: CGM.
Кому может быть актуально
Состояния в реестре: Infertility Female. Базовые параметры: 18 лет — 40 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

Glucose Pattern in Infertile Women Receiving Assisted Reproduction: a Prospective Study Using Continuous Glucose Monitoring

Обзор

No studies have been seen on glucose variation during medication for assisted reproduction. The aim of this study is to continuously observe glucose variation during assisted reproduction treatment using continuous glucose monitoring (CGM), and to further explore whether glucose variation will affect the outcomes related to assisted reproduction.

Подробное описание

Infertility is a growing global health concern and affects approximately 20% of couples of reproductive age. As a result, the use of assisted reproductive technologies (ART) is becoming more prevalent. This study could serve as a basis for the interpretation of glucose levels with respect to these people undergoing ART regimen. Moreover, the success rate of ART still needs to be further improved. Key challenges include optimizing the hormonal components of ART regimens and determining the ideal treatment duration. This study might provide insights into the potential benefits of monitoring glucose levels at specific points during ART cycles (which is not usually performed in routine practice) and help clinicians tailor ART regimen to minimize glucose variation, ultimately improving clinical pregnancy and live birth rates. Additionally, the findings might support integrating CGM into the clinical practice of ART, enhancing individualized patient care.

Вмешательства

  • Устройство CGM
    Each patient will participate in the group only once and wear two FreeStyle Libre Pro Flash CGM (Abbott Diabetes Care, Alameda, CA, USA), which record glucose readings for up to 14 days. Following the initial consultation and before initiating the ovulation induction protocol, the first CGM sensor will be placed to collect baseline data. Upon entering the ovulation induction cycle, patients will return to the hospital on the 2nd or 3rd day of menstruation, at which point the first CGM sensor wi

Первичные конечные точки

  • Mean sensor glucose (MSG) [Срок оценки: Through study completion (during assisted reproductive treatment period，about 2 months）]
Вторичные конечные точки (5)
  • time in tight range(3.9~7.8mmol/L, %) [Срок оценки: Through study completion (during assisted reproductive treatment period，about 2 months）]
  • Time below range (<3.9mmol/L, %) [Срок оценки: Through study completion (during assisted reproductive treatment period，about 2 months）]
  • Time above range (>7.8mmol/L, %) [Срок оценки: Through study completion (during assisted reproductive treatment period，about 2 months）]
  • Coefficient of variation (CV) [Срок оценки: Through study completion (during assisted reproductive treatment period，about 2 months）]
  • Standard deviation (SD) [Срок оценки: Through study completion (during assisted reproductive treatment period，about 2 months）]

Критерии участия

Критерии включения

  • Informed consent and voluntary participation in this study;
  • Age ≥ 18 years and ≤40 years old;
  • Infertile patients who will undergo their first or second cycle of in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) at the study center;
  • The chosen ovulation promotion regimens is the GnRH antagonist regimen/progesterone-promoting ovulation under hyperprogesterone state (PPOS) regimen.

Критерии исключения

  • Recent infections (excluding viral infections of the reproductive system such as HPV);
  • Recent glucocorticoid treatment or chemotherapy;
  • Clinical conditions affecting the outcome of assisted reproduction, including repeated implantation failure, recurrent spontaneous abortion, history of unilateral oophorectomy, uterine malformations, and parental karyotype abnormalities;
  • Participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Китай · 1 центр
  • Shanghai Sixth People's Hospital — Шанхай

Идентификаторы

NCT: NCT06863337 · 20250303

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗