Assisted Reproductive Techniques, Cryopreservation of Embryos, Frozen Embryo Transfer (FET), In Vitro Fertilization (IVF), Pregnancy Outcome After in Vitro Fertilization (IVF)
Conditions
Keywords
Direct Warming Method, Frozen Embryo Transfer, Assisted Reproductive Technologies, Cryopreservation, Cost-effectiveness in ART, Embryo Warming, In Vitro Fertilization
Brief summary
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.
Detailed description
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.
Interventions
OTHERDirect Warming Method
This intervention involves thawing vitrified blastocysts using a simplified, one-step direct warming method. The blastocyst is placed in a pre-warmed embryo culture medium for approximately one minute, then transferred directly into the embryo culture medium within a time-lapse system until ready for uterine transfer. The total thawing process takes approximately three minutes, reducing the duration and complexity of the procedure compared to conventional methods.
OTHERConventional Multi-step Thawing Method
This intervention involves thawing vitrified blastocysts using a standard, multi-step process. The procedure includes sequential exposure of the blastocyst to different thawing solutions containing varying concentrations of cryoprotectants, followed by its transfer into an embryo culture medium in a time-lapse system. The overall process takes approximately 10-30 minutes.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
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.
Intervention model description
This study uses a parallel assignment model where participants are randomized into two groups: one group will receive the novel direct warming method, and the other group will undergo the conventional multi-step thawing method. Both groups will be followed to compare clinical outcomes such as pregnancy rates, live birth rates, and cost-effectiveness.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy Rate | 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) | 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) | At delivery, approximately 9 months post embryo transfer | Number of participants who deliver a live infant after 24 weeks of gestation. |
| Cost-Effectiveness | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subgroup Analysis of Warming Medium | Throughout the study period, approximately 4 years. | Analysis of the clinical differences between brands of warming mediums assessing their impact on embryo survival rate. |
| Subgroup Analysis of Storage Devices | Throughout the study period, approximately 4 years. | Analysis of the clinical differences between brands of Storage Devices assessing their impact on embryo survival rate. |
Countries
Hong Kong, United Kingdom
Contacts
Primary ContactYiu Leung D Chan, DPhil
Backup ContactWaner Wu, MPhil
Outcome results
None listed