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Single Step Protocol and Multi-step Warming Protocol for Blastocyst FET

NCT07088640 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 816

Last updated 2025-09-12

No results posted yet for this study

Summary

The multi-step thawing protocol with a reduction of non-permeable cryoprotectant concentrations to reduce osmotic shock caused by the rapid influx of water. Recent studies have shown that a simplified warming protocol by only a thawing solution gave a comparable survival rate but increased pregnancy rate, reduced patients' waiting time, and decreased the workload of embryologists.

Conditions

  • IVF
  • Frozen Embryo Transfer (FET)
  • Embryo Thawing Protocol

Interventions

PROCEDURE

Single-step warming protocol by thawing solution only

Potentially eligible patients' vitrified blastocysts will be thawed by a single-step thawing protocol. For the warming phase, vitrified blastocysts are exposed to the thawing solution of a commercial embryo thawing kit (Irvine Scientific Inc., USA) at 37°C for one minute. Immediately following this, embryos will be rinsed in a 35mm diameter dish of 2ml of pre-equilibrated thawing solution before being placed in culture media in the incubator for at least 2 hours before transfer.

PROCEDURE

Standard warming protocol

For the MS protocol, thawing kits were equilibrated overnight in a 37°C incubator. Warming procedures utilized the kits (Cryotech RtU, Japan). To remove the cryoprotectants, blastocysts were warmed, and cryoprotectants were diluted in a three-step process. The warming process starts with the exposure of blastocysts to thaw solution (TS) with 1M trehalose for one minute at 37°C. Subsequently, the blastocyst will be transferred to a second well containing a dilution solution (DS) of 0.5M trehalose for a two-minute rinse at room temperature. This is followed by two additional three-minute and 30-second rinses in the wash solution (WS) at room temperature. The timeline for standard warming of blastocysts requires a total of 6.5 min. After thawing, embryo will be placed in the incubator at least 2 hours before transfer.

Sponsors & Collaborators

  • Mỹ Đức Hospital

    lead OTHER

Principal Investigators

  • Lan TN Vuong, MD, PhD · University of Medicine and Pharmacy at Ho Chi Minh City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-13
Primary Completion
2026-12-31
Completion
2027-03-01

Countries

  • Vietnam

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 NCT07088640 on ClinicalTrials.gov