Efficacy of a Non-Invasive Endometrial Receptivity Prediction Model Based on Peripheral Blood miRNA Signatures During the Peri-Implantation Period in Improving IVF Outcomes in Patients With Unexplained RIF

Официальное название

Efficacy of a Non-Invasive Endometrial Receptivity Prediction Model Based on Peripheral Blood miRNA Signatures During the Peri-Implantation Period in Improving IVF Outcomes in Patients With Unexplained Recurrent Implantation Failure: A Prospective, Single-Blind, Two-Arm, Parallel Randomized Controlled Trial

Обзор

The goal of this clinical trial aims to investigate whether a non-invasive implantation window prediction model, constructed based on characteristic changes in peripheral blood miRNAs during the peri-implantation period, can improve pregnancy outcomes in patients with unexplained recurrent implantation failure undergoing frozen embryo transfer. Researchers will compare the clinical pregnancy outcomes between individualized embryo transfer guided by implantation window results and conventional embryo transfer, to observe whether implantation window-guided individualized embryo transfer can improve the clinical efficacy for patients with recurrent implantation failure (RIF). Participants will complete implantation window testing as required by the study protocol, undergo randomization and blinding, and proceed with embryo transfer according to their assigned group.

Вмешательства

• Диагностический тест Non-invasive endometrial receptivity prediction model guides personalized embryo transfer for patients with recurrent implantation failure (RIF).
  Participants will undergo personalized embryo transfer based on the detection results of the window of implantation (WOI) via peripheral blood miRNA analysis. For subjects whose WOI results indicate that Day 5 (D5) is non-receptive, the embryo transfer timing will be appropriately advanced or delayed by 24 or 48 hours relative to the standard time. For subjects whose WOI results indicate that D5 is receptive, embryo transfer will be performed at the standard time (the fifth day after ovulation).

Первичные конечные точки

• Implantation rate per embryo transferred, assessed by counting gestational sacs on ultrasound. [Срок оценки: From the day of embryo transfer until the completion of the first ultrasound assessment (typically at 35 days ± 7 days after transfer).]

Вторичные конечные точки (3)

• Proportion of patients with abnormal endometrial receptivity, as assessed by dynamic changes in peripheral blood microRNA levels 5 days after ovulation. [Срок оценки: From the day of ovulation trigger until the completion of microRNA sample collection and analysis (within 5 to 7 days post-trigger).]
• Clinical pregnancy rate per embryo transfer, confirmed by ultrasound visualization of gestational sac and fetal heartbeat. [Срок оценки: From the day of embryo transfer until the confirmation of clinical pregnancy by ultrasound (assessed at approximately 35 days ± 7 days after embryo transfer).]
• Ongoing Pregnancy Rate per embryo transfer, confirmed by ultrasound after 12 weeks of gestation. [Срок оценки: From the day of embryo transfer until the confirmation of fetal viability at or after 12 weeks of gestation (typically up to 14 weeks of gestation).]

Критерии участия

Критерии включения

• Patients with unexplained recurrent implantation failure (RIF) meeting the diagnostic criteria for RIF: adult women under 40 years old who have failed to achieve clinical pregnancy after 3 embryo transfer cycles; or after transferring at least 3 high-quality embryos.

Definition of high-quality embryos: Day 3 embryos (with a cell count ≥7 and fragmentation rate <10%) and blastocysts (≥3BB).

• Female BMI: 18.5-25 kg/m².
• Endometrial thickness ≥7 mm during the embryo transfer cycle.
• Women planning to undergo frozen-thawed embryo transfer (FET) of blastocysts following in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
• Signed informed consent form.

Критерии исключения

• Known causes of embryo implantation failure, such as infections, reproductive tract malformations, uterine cavity factors, adenomyosis or endometriosis, autoimmune system diseases (diagnosed by immunology department), hydrosalpinx, etc.
• Couples with chromosomal abnormalities (excluding chromosomal polymorphisms) or familial genetic disorders in either or both partners.
• Women with a history of recurrent miscarriage.
• Women with contraindications to pregnancy or assisted reproductive technology.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07363018 · 20251123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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