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.
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.
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.
Parallel
Direct Warming Method
Other interventionThis 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.
Conventional Multi-step Thawing Method
Other interventionThis 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.
Clinical Pregnancy Rate
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)
Number of participants with a viable intrauterine pregnancy observed on ultrasound at 12 weeks of gestation.
Live Birth Rate (LBR)
Number of participants who deliver a live infant after 24 weeks of gestation.
Cost-Effectiveness
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.
Subgroup Analysis of Warming Medium
Analysis of the clinical differences between brands of warming mediums assessing their impact on embryo survival rate.
Subgroup Analysis of Storage Devices
Analysis of the clinical differences between brands of Storage Devices assessing their impact on embryo survival rate.
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This trial is not recruiting at the moment. You can still explore other options:
