Randomized Controlled Trial Comparing Hyaluronan-enriched Embryo Transfer Medium Versus Control for Frozen-thawed Embryo Transfer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 2
- 主要终点
- Live-birth rate per embryo transfer procedure
研究概览
简要总结
This is a randomized-controlled trial evaluating the effect of the use of hyaluronan (HA)-enriched embryo transfer medium on the live birth rate in women undergoing frozen-thawed embryo transfer. For half of the women, hyaluronan-enriched medium will be used as embryo transfer medium. For the other half of women, a control will be used.
详细描述
Women being scheduled for FET will be assessed for eligibility. Eligible women will be recruited for the study and each woman will only be included in the study with one FET cycle. Informed written consent will be obtained. Their baseline characteristics will be collected.
Women with regular ovulatory cycles will undergo the standard procedures of blood taking to identify the day of luteinizing hormone (LH) surge. Women with irregular cycles will either receive clomiphene or letrozole followed by detection of the LH surge, or undergo hormone replacement therapy (HRT) cycle with oral oestradiol 6 mg daily for 14 days for endometrial priming followed by the addition of vaginal micronized progesterone 100 mg three times daily. HRT cycle may also be used for scheduling purposes.
Embryo transfer will be performed 3 or 4 days (for cleavage-stage embryos) or 6 or 7 days (for blastocysts) after the LH surge. For women in HRT cycles, FET will be scheduled on the 4th or 5th day (for cleavage-stage embryos) or the 7th or 8th day (for blastocysts) of starting vaginal progesterone. They will continue oral oestradiol and vaginal progesterone after FET up to 12 weeks of gestation.
Randomization:
One day before scheduled FET, recruited women will be randomized into one of the following two groups: (1) HA group and (2) control group according to a computer-generated randomization list prepared by a designated research nurse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women panning to replacing early cleavage embryos or blastocysts after thawing.
排除标准
- •Frozen early cleavage embryos thawed and cultured to blastocysts prior to transfer as requested by the patient
- •Preimplantation genetic diagnosis treatment
- •Use of donor oocytes or donor embryos
- •Endometrial thickness <8mm on the day of the luteinizing hormone surge or after two weeks of estrogen in hormonal replacement cycles
- •Hydrosalpinx shown on pelvic scanning and not surgically treated
研究组 & 干预措施
HA group
One the day of frozen-thawed embryo transfer, frozen embryos will be thawed and incubated for at least 10 minutes in embryo transfer medium. For women allocated to the HA group, EmbryoGlue (Vitrolife), a hyaluronan-enriched embryo transfer medium, will be used as embryo transfer medium. EmbryoGlue contains a higher concentration of hyaluronan than the control medium.
干预措施: EmbryoGlue (Vitrolife) (Other)
Control group
For women allocated to the control group, the usual transfer medium used in the study centers will be used and will serve as control. The main difference between the two media is that EmbryoGlue contains a higher concentration of HA.
干预措施: Control medium (Other)
结局指标
主要结局
Live-birth rate per embryo transfer procedure
时间窗: 1 year
次要结局
- implantation rate(8 weeks)
- adverse events(12 weeks)
- on-going pregnancy rate(8 weeks)
- obstetric complications(1 year)
- pregnancy rate(4 weeks)
- clinical pregnancy rate(4 weeks)
研究者
Dr. YUNG Shuk Fei Sofie
Clinical Assistant Professor
The University of Hong Kong