【ChiCTR2600133941】One-step Rehydration Thawing Method in Frozen Embryo Transfer: A pragmatic randomized controlled clinical trial (ORT-FET-RCT)

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基本信息

登记号

ChiCTR2600133941

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2026-10-09

临床申请受理号

靶点

适应症

Frozen embryo transfer

试验通俗题目

One-step Rehydration Thawing Method in Frozen Embryo Transfer: A pragmatic randomized controlled clinical trial (ORT-FET-RCT)

试验专业题目

One-step Rehydration Thawing Method in Frozen Embryo Transfer: A pragmatic randomized controlled clinical trial (ORT-FET-RCT)

申办单位信息

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联系人邮编

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临床试验信息

试验目的

The primary objective is to evaluate the clinical outcomes and cost-effectiveness of the novel direct warming method compared to the conventional multi-step warming method for FET in terms of clinical pregnancy rate (CPR), ongoing pregnancy rate (OPR), live birth rate (LBR), miscarriage rate and time efficiency, cost-effectiveness. The secondary objective is to evaluate the impact of technical variations (warming media, storage devices, and culture media) on clinical outcomes between the direct warming method and the conventional multi-step method.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

A stratified randomization approach will be used to ensure balanced distribution of participants across treatment groups based on age, a key factor influencing embryo warming and transfer outcomes. Participants will be stratified into three age groups: <30 years, 30-34 years, and ≥35 years. Within each age stratum, participants will be randomly assigned to one of two study groups (conventional warming or direct warming) using a computerized randomization process in SPSS. Random numbers will be generated for each participant, and participants will be assigned to the intervention or control group based on these random numbers, ensuring even distribution across groups within each age stratum. In the case of an odd number of participants in any stratum, the remaining participant will be randomly assigned to one of the two groups. This method ensures that participants are randomized within each stratum, achieving a balance in age distribution across the treatment groups.

盲法

These envelopes will be prepared in advance and will only be opened by the embryologist responsible for embryo handling. The research staff/nurse/clinician responsible for enrolling participants will not be aware of group assignments, ensuring allocation concealment until the interventions are carried out. After the embryo transfer, if it is determined that the patient is not pregnant, their group assignment may be disclosed to them. However, if pregnancy is confirmed, the group assignment will remain concealed, and the patient will not be informed until a live birth occurs, or in the event of a miscarriage or elective termination. This approach ensures allocation concealment throughout the pregnancy, minimizing bias and maintaining the integrity of the trial.

试验项目经费来源

Hong Kong Health and Medical Fund (Ref18190321), Hong Kong Research Matching Grant (RMG01-8601386)

试验范围

目标入组人数

289

实际入组人数

第一例入组时间

2025-10-01

试验终止时间

2027-10-31

是否属于一致性

入选标准

Patients undergoing FET cycle and plan for a single embryo transfer.；

排除标准

Patients with repeated implantation failure (RIF), recurrent miscarriage (RM), uterus anomaly, and embryo retention during transfer will be excluded, blastocysts with a grade C morphology either in inner cell mass or trophectoderm.；

研究者信息

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试验机构

The Chinese University of Hong Kong

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