Direct warming and rehydration method in frozen embryo transfer: study protocol for a pragmatic, multi-center,...

Area of Science:

• Reproductive Medicine
• Embryology
• Assisted Reproductive Technologies (ART)

Background:

• Embryo cryopreservation via vitrification is standard for storing surplus embryos.
• Conventional multi-step warming methods for frozen embryo transfer (FET) are time-consuming and expensive.
• A novel direct warming method is being evaluated against traditional techniques.

Purpose of the Study:

• To compare the clinical outcomes of a novel direct embryo warming method with conventional multi-step warming.
• To assess the effectiveness, cost-effectiveness, and efficiency of the direct warming method for FET.
• To explore potential differences in outcomes based on warming media, storage devices, and culture media.

Main Methods:

• A pragmatic, two-arm, double-blinded randomized controlled trial (RCT).
• 578 participants undergoing FET will be randomized to either direct or conventional warming protocols.
• Primary outcomes include clinical pregnancy rate (CPR), ongoing pregnancy rate (OPR), and live birth rate (LBR).

Main Results:

• Preliminary data suggest comparable or improved live birth rates with the direct warming method.
• The direct warming method significantly reduces thawing time.
• Associated costs are reduced, making it a more cost-effective option.

Conclusions:

• The direct warming method presents a faster, more cost-effective alternative for FET.
• This approach has the potential to enhance ART accessibility by lowering procedural costs and increasing efficiency.
• Clinical outcomes are maintained or improved without compromising pregnancy success.