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Direct Warming Frozen Embryo Transfer Outcomes in Assisted Reproductive Technology

NCT06741748 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 578

Last updated 2025-03-11

No results posted yet for this study

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.

Conditions

  • Frozen Embryo Transfer (FET)
  • Assisted Reproductive Techniques
  • In Vitro Fertilization (IVF)
  • Cryopreservation of Embryos
  • Pregnancy Outcome After in Vitro Fertilization (IVF)

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-10-31
Completion
2027-10-31

Countries

  • Hong Kong
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06741748 on ClinicalTrials.gov