The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)

Официальное название

Clinical Outcomes of Letrozole-induced Endometrial Preparation Regimens Versus Conventional Endometrial Preparation Regimens Including Natural Cycle, Hormone Replacement Regimens in FET, a Randomized Controlled Study

Обзор

The goal of this single center, non-blinded, randomized controlled clinical trial to comparison of pregnancy outcomes and perinatal outcomes in patients undergoing IVF treatment (including ICSI) with FET with letrozole-induce endothelial preparation protocol versus natural cycles, hormone replacement protocol. The main questions it aims to answer are: * To investigate whether letrozole-induce endothelial preparation is effective in improving the live birth rate and clinical pregnancy rate. * To explore its possible impact on clinically important indicators such as spontaneous abortion rate, implantation cycle cancellation rate, days of endothelial preparation, and number of visits to the clinic. The study subjects were randomized into groups starting at D1-D3 of the menstrual cycle. The study subjects were stratified according to whether their menstrual cycles were regular or not, and were divided into the following endothelial preparation regimens according to the pre-prepared stratified zoned randomized group numbers: (1) regular menstrual cycles (25-35 d): letrozole ovulation-promoting cycles, natural cycles, and hormone-replacement cycles; and (2) irregular menstrual cycles (\<25 d or \>35 d): letrozole ovulation-promoting cycles, hormone-replacement cycle.

Вмешательства

• Препарат Letrozole
  Different endothelial preparations according to groups, see arm descriptions for details

Первичные конечные точки

• Live birth [Срок оценки: 40-42 weeks'estimated gestational age]

Вторичные конечные точки (2)

• Clinical pregnancy [Срок оценки: 5-7 weeks' estimated gestational age]
• embryo implantation [Срок оценки: 14 day after embryo transfer]

Критерии участия

Критерии включения

Women <40 years of age undergoing IVF or ICSI at our reproductive center with a total of ≤3 superovulation cycles , and with ≥2 cleavage embryos or ≥1 blastocyst were cryopreserved. Previous cycles of embryo transfer ≤ 2 and only one transfer cycle with 1-2 embryos per study subject was enrolled.

Критерии исключения

• Patients with chromosomal abnormalities in either spouse, hydrosalpinx, severe endometriosis, adenomyosis, and uterine and uterine cavity organic diseases such as uterine malformations, endometrial polyps, and uterine adhesions;
• patients who underwent pre-implantation genetic diagnosis (PGT);
• patients who underwent ICSI using surgically obtained epididymal or testicular spermatozoa;
• patients with a Body mass index (BMI, = weight/height2 ) > 30 kg/m2;
• patients with recurrent spontaneous abortions;
• patients with sequential embryo transfer.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Yu Xiao — Шанхай

Идентификаторы

NCT: NCT06006091 · InternationalPMCHH-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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