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NCT06741748
NA

Direct Warming Frozen Embryo Transfer Outcomes in Assisted Reproductive Technology

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

578

Start Date

2025-09-01

Completion Date

2027-10-31

Last Updated

2025-03-11

Healthy Volunteers

No

Interventions

OTHER

Direct 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.

OTHER

Conventional 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.

Locations (3)

The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong SAR, Hong Kong

The CUHK Medical centre

Shatin,NT, Hong Kong SAR, Hong Kong

The Homerton Hospital

London, London, United Kingdom