A Pragmatic, Multi-centre, Double-blinded, Two-arm Randomized Controlled Trial on a Direct Warming Frozen Embryo Transfer in Assisted Reproductive Technologies Treatment Outcome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 578
- 试验地点
- 3
- 主要终点
- Clinical Pregnancy Rate
研究概览
简要总结
The goal of this clinical trial is to evaluate whether the direct warming method for frozen embryo transfers (FET) can improve live birth and pregnancy outcomes in women aged 18-45 undergoing IVF treatments. The main questions it aims to answer are:
- Does the direct warming method achieve a similar or higher clinical success rate for FET compared to the conventional multi-step method?
- Is the direct warming method more cost-effective than the conventional method?
Researchers will compare the direct warming method to the conventional multi-step method to see if the former leads to better pregnancy outcomes and reduced procedural time.
Participants will:
- Undergo either the one-step or conventional embryo thawing procedure.
- Complete standard clinical follow-ups for pregnancy, including ultrasound scans and pregnancy tests.
详细描述
This clinical trial explores a novel direct warming method for frozen embryo transfer (FET), aimed at improving both clinical and operational outcomes in assisted reproductive technologies (ART). The method was designed to simplify and accelerate the embryo thawing process, reducing the time needed for thawing while eliminating the use of cryoprotectants commonly required in conventional thawing methods. This innovation has the potential to offer a more efficient and cost-effective alternative to standard FET procedures.
The primary focus of this trial is to compare the clinical effectiveness of the direct warming method against the conventional multi-step thawing process. In particular, the study seeks to determine whether the new method yields comparable or superior outcomes in terms of clinical pregnancy rate (CPR), ongoing pregnancy rate (OPR), and live birth rate (LBR), while also assessing its overall cost-effectiveness.
Study Design and Technical Details
This study employs a randomized controlled design, with participants being allocated into either the intervention group (direct warming method) or the control group (conventional multi-step thawing). The direct warming method streamlines the thawing process to just 3 minutes, in contrast to the conventional method, which requires multiple stages and takes approximately 20 minutes. By using only an embryo culture medium without cryoprotectants, the direct warming method reduces both complexity and potential risks associated with handling and cryoprotectant toxicity.
Key Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
In this trial, participants and outcomes assessors will be masked to ensure unbiased results. The embryologists performing the thawing procedures will not be masked, as they are directly involved in applying the assigned thawing method (either the direct warming method or the conventional multi-step method). Additionally, the research staff responsible for enrolling participants will also remain blinded to group assignments to maintain allocation concealment. However, participants who are determined not to be pregnant after embryo transfer may be informed of their group assignment at that time. However, if a pregnancy is confirmed, participants will not be informed of their group assignment until after delivery or in the event of pregnancy loss.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Plan to undergo single embryo transfer (SET) during the FET cycle.
- •Age between 18 and 45 years.
- •Patients with at least one high-quality blastocyst available for transfer.
- •Patients who have provided informed consent to participate in the study.
排除标准
- •Patients with repeated implantation failure (RIF) or recurrent miscarriage (RM).
- •Patients with known uterine anomalies or significant uterine pathology (e.g., fibroids, polyps).
- •Patients who are unwilling or unable to provide informed consent.
结局指标
主要结局
Clinical Pregnancy Rate
时间窗: 6-8 weeks post embryo transfer
Number of participants with at least one intrauterine gestational sac observed on ultrasound at 6-8 weeks of gestation following embryo transfer.
Ongoing Pregnancy Rate (OPR)
时间窗: 12 weeks post embryo transfer
Number of participants with a viable intrauterine pregnancy observed on ultrasound at 12 weeks of gestation.
Live Birth Rate (LBR)
时间窗: At delivery, approximately 9 months post embryo transfer
Number of participants who deliver a live infant after 24 weeks of gestation.
Cost-Effectiveness
时间窗: At the end of the study, approximately 4 years.
A comparative analysis of the total costs, including costs of consumables (e.g., warming mediums, storage devices) and staff labor hours, associated with the direct warming method compared to the conventional multi-step thawing method. Costs will be measured in USD and analyzed at the end of the study period.
次要结局
- Subgroup Analysis of Warming Medium(Throughout the study period, approximately 4 years.)
- Subgroup Analysis of Storage Devices(Throughout the study period, approximately 4 years.)
研究者
Yiu Leung David Chan
Assistant Professor
Chinese University of Hong Kong