Chinese University of Hong Kong
Yiu Leung David Chan
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.
Frozen Embryo Transfer (FET)
Assisted Reproductive Techniques
In Vitro Fertilization (IVF)
Cryopreservation of Embryos
Pregnancy Outcome After in Vitro Fertilization (IVF)
Direct Warming Method
Conventional Multi-step Thawing Method
NA
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 * Primary Objective: To evaluate the clinical efficacy of the direct warming method in achieving comparable or higher success rates for FET as compared to conventional multi-step thawing. * Secondary Objective: To assess the cost-effectiveness of the direct warming method by comparing the consumable and time costs across different centers. Expected Impact and Innovation The direct warming method challenges the traditional multi-step thawing approach, offering a faster and simpler alternative without compromising clinical outcomes. By minimizing the need for cryoprotectants and reducing the complexity of the thawing process, the new method is expected to enhance the overall efficiency of FET procedures while maintaining or improving pregnancy success rates. Additionally, the cost and time savings associated with the direct warming method may make it a viable option for IVF clinics worldwide, driving standardization and consistency across clinical settings.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 578 participants |
| Masking : | DOUBLE |
| Masking Description : | 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. |
| Primary Purpose : | TREATMENT |
| Official Title : | A Pragmatic, Multi-centre, Double-blinded, Two-arm Randomized Controlled Trial on a Direct Warming Frozen Embryo Transfer in Assisted Reproductive Technologies Treatment Outcome |
| Actual Study Start Date : | 2025-09-01 |
| Estimated Primary Completion Date : | 2026-10-31 |
| Estimated Study Completion Date : | 2027-10-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 45 Years |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
The Chinese University of Hong Kong
Shatin, New Territories, Hong Kong SAR, Hong Kong,
Not yet recruiting
The CUHK Medical centre
Shin, NT, Hong Kong SAR, Hong Kong,
Not yet recruiting
The Homerton Hospital
London, United Kingdom,