Идёт набор NCT05502770

Development of IVF/ICSI Children Born From Different Endometrial Preparation Protocols

— Наблюдательное Child Development Endometrial Preparation

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: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3, Physical development and General Health, Developmental Red flags.
Кому может быть актуально: Состояния в реестре: Child Development, Endometrial Preparation. Базовые параметры: 6 мес. — 18 мес. · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Вьетнам
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

Development of IVF/ICSI Children Born From Frozen Embryo Transfer Cycles With Different Endometrial Preparation Protocols: Follow-up of a Randomized Controlled Trial

Обзор

The efficacy and safety of endometrial preparation regimens remain controversial. In the most recent meta-analysis, using natural and modified natural cycle protocol to prepare the endometrium in frozen embryo transfer resulted in higher live birth rates. In addition, the natural cycle reduces the risk of gestational hypertension, postpartum haemorrhage, and extremely preterm delivery compared with regimens using exogenous hormones. Because there are many physiological and endocrinal differences in the frozen embryo transfer cycle with different endometrial preparation protocols, the development of children born from these regimens has received much attention. For example, there is a complete absence of the corpus luteum during the cycle of exogenous hormone administration. Or in the modified natural cycle, the pharmacokinetics is not entirely the same as the natural physiology when using an additional ovulatory injection with hCG. To date, there have been no longitudinal follow-up studies that evaluated and compared the long-term development of IVF/ICSI children born from frozen embryo transfer with different endometrial preparation protocols. Thus, the investigators conduct a follow-up of our RCT to investigate the IVF/ICSI children born from frozen embryo transfer with different endometrial preparation protocols to give strong evidence about the safety of the three most common endometrial preparation protocols in women undergoing frozen embryo transfer.

Подробное описание

Developing further from a previous randomized controlled clinical trial (MONART study - NCT04804020), the investigators decided to assess the physical, mental, and motor development of children up to 24 months after birth, with the aim of providing additional information on the safety of these regimens on the long-term health of the IVF/ICSI children.

Вмешательства

Диагностический тест Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3
Ages \& Stages Questionnaires®, Third Edition (ASQ®-3) is a developmental screening tool designed for use by early educators and health care professionals. It relies on parents as experts, is easy-to-use, family-friendly and creates the snapshot needed to catch delays and celebrate milestones.
Другое Physical development and General Health
Physical development and General health examination
Диагностический тест Developmental Red flags
Developmental Red flags Questionnaires

Первичные конечные точки

The average total ASQ-3 score [Срок оценки: Up to 24 months after birth]

Вторичные конечные точки (6)

Score of Communication [Срок оценки: Up to 24 months after birth]
Score of Gross motor [Срок оценки: Up to 24 months after birth]
Score of Fine motor [Срок оценки: Up to 24 months after birth]
Score of Problem solving [Срок оценки: Up to 24 months after birth]
Score of Personal-Social [Срок оценки: Up to 24 months after birth]
The rate of children who have at least one red flag sign [Срок оценки: From 6 months to 24 months after birth]

Критерии участия

Критерии включения

All live IVF/ICSI babies born from frozen embryo transfer following the natural cycle, modified natural cycle, and artificial cycle from MONART study
Parents agree to participate in the study.