Идёт набор NCT06177613

Advantages of Early Intrauterine Transfer of "Blank" Culture Medium Prior to 1st or 2nd Transfer of Thawed Embryo(s).

Без фазы С лечением Single Embryo Transfer Fertilization in Vitro

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: Blank culture transfer, Sham transfer.
Кому может быть актуально: Состояния в реестре: Single Embryo Transfer, Fertilization in Vitro. Базовые параметры: Без ограничений · 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: Франция, Reunion
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

Advantages of Early Intrauterine Transfer of "Blank" Culture Medium Prior to 1st or 2nd Transfer of Thawed Embryo(s). Randomized, Single-blind, Multicenter Controlled Trial.

Обзор

Despite technical advances in Medically Assisted Reproduction (AMP), the success of fertility treatments is sometimes limited by embryo implantation failure. The coordinated development of the embryo and the uterine endometrium requires close communication between the maternal tissue and the embryo. In in vitro fertilization (IVF), embryo transfer generally takes place between the 2nd (D2) and the 6th (D6) day following oocyte fertilization. Recent studies have shown the advantages of sequential transfer (transfer of an embryo on D2/D3 followed by the transfer of another embryo on D5/D6), with higher implantation and clinical pregnancy rate, fewer miscarriages, more live births, and yet no increase in multiple pregnancies. However, the American Society for Reproductive Medicine recommendations continue to prioritize the transfer of a single embryo for all patients aged under 38. To improve pregnancy rates for patients having a single embryo transferred, the study investigators wish to carry out on "blank" transfer, based on the principle of sequential transfer. The study investigators hypothesize that a culture medium, placed in the uterus before the time of embryo transfer, will modify immune tolerance. The study will test whether transferring the same culture medium in an equivalent quantity as during the real transfer into the uterus 2/3 days before the embryo transfer will improve tolerance to this foreign medium and, therefore, embryo implantation. The aim of this study is thus to evaluate the impact of a "blank" transfer with culture medium alone, on the results of frozen embryo transfers (FET) from IVF.

Вмешательства

Процедура Blank culture transfer
A maximum of 0.1 ml of gassed embryo culture medium preheated to 37°C is injected into the uterine cavity transcervically using an embryo transfer catheter placed just beyond the internal os, two to 3 days before transfer of the thawed embryo
Процедура Sham transfer
An intermediate transfer step is added two or three days before the planned transfer of the frozen embryo but with an empty catheter.

Первичные конечные точки

Clinically progressive pregnancy rate between groups [Срок оценки: 12 weeks of amenorrhea]

Вторичные конечные точки (7)

Occurrence of pregnancy between groups [Срок оценки: Day 14]
Occurrence of a biochemical pregnancy between groups [Срок оценки: Day 14]
Occurrence of a clinical pregnancy between groups [Срок оценки: 6 weeks of amenorrhea]
Occurrence of an early miscarriage between groups [Срок оценки: 12 weeks of amenorrhea]
Occurrence of live birth [Срок оценки: Upon giving birth (maximum month 9)]
Differential cost-result ratio [Срок оценки: End of study (Year 3)]
Total estimated expenditure for the two care strategies compared (budget impact analysis) over a one-year time horizon. [Срок оценки: End of study (Year 3)]

Критерии участия

Критерии включения

Having had a first "fresh" or frozen embryo transfer, whatever the embryo's stage of development, transfer followed by pregnancy failure ;
Frozen embryos must be at least D3 stage;
The patient must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan

Критерии исключения

The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
The patient is under safeguard of justice or state guardianship

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

Здоровые добровольцы: Нет