The Impact of Laser-Assisted Hatching on Pregnancy Outcomes After Vitrified-Warmed Embryo Transfer in Advanced-age Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 916
- 主要终点
- Live birth rate
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of laser assisted hatching (LAH) on pregnancy outcomes, with live birth rate as the primary outcome, in advanced age infertile women aged ≥35 years who are undergoing non-donor IVF/ICSI cycles and planning vitrified-warmed embryo transfer. It also aims to monitor the safety of LAH and assess various secondary pregnancy and neonatal outcomes. The main questions it aims to answer are:
Does laser assisted hatching improve the live birth rate in advanced age women undergoing vitrified-warmed embryo transfer? Does laser assisted hatching affect secondary outcomes including implantation rate, biochemical pregnancy rate, clinical pregnancy rate, ectopic pregnancy rate, ongoing pregnancy rate, miscarriage rate, multiple pregnancy rate, preterm birth rate, and rates of obstetric and neonatal complications as well as congenital anomalies? Researchers will compare the Laser Assisted Hatching (LAH) Group to the Control Group (without LAH) to see if LAH can improve pregnancy outcomes in the study population.
Participants will:
- Be randomly assigned to either the LAH Group or the Control Group at a 1:1 ratio, stratified by age (<40 years/≥40 years) and embryo stage (cleavage stage/blastocyst) using stratified block randomization.
- Undergo the first or second frozen-thawed embryo transfer cycle, with transferred embryos meeting the quality criteria (cleavage-stage embryos: Grade I, Grade II, or CP and above; blastocysts: 4BC/CB and above).
- Receive embryo vitrification and warming after routine fertilization and culture; LAH Group will undergo LAH (thinning zona pellucida for cleavage-stage embryos, removing 1/4-1/3 of zona pellucida circumference for blastocysts) in G2 medium after embryo thawing, while Control Group will not receive assisted hatching.
- Have endometrial preparation by natural, ovulatory, or hormone replacement cycles as appropriate, and 1-2 viable embryos will be transferred under ultrasound guidance within 3 hours after thawing, followed by routine luteal support after transfer.
- Complete follow-up at multiple time points: 12-15 days after embryo transfer (serum β-hCG test), 28 days after embryo transfer (transvaginal ultrasound), 12 weeks of gestation (ultrasound), 28 weeks of gestation (ultrasound), and 1 month after delivery (collection of delivery and neonatal information).
- Provide demographic, clinical, and embryological baseline data, as well as various outcome data during the study period.
- Undergo regular monitoring of vital signs, laboratory test results, and adverse events, with key prevention and control of specific risks related to LAH such as embryo damage and multiple pregnancy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1: Female age ≥ 35 years
- •2: First or second vitrified-warmed embryo transfer cycle
- •3: Quality of embryos for transfer meeting the criteria: Grade I, II, CP or above (cleavage-stage embryos); Grade 4BC/CB or above (blastocysts)
- •4: Provide written informed consent
排除标准
- •1: Use of donor oocytes or sperm, or planned preimplantation genetic testing (PGT)
- •2: Severe immune or chromosomal abnormalities
- •3: Uterine cavity abnormalities (i.e., adenomyosis, submucous uterine fibroids, hydrosalpinx, uterine septum, and endometrial polyps)
- •4: Embryos with an abnormal zona pellucida
- •5: Complicated with severe underlying diseases (e.g., uncontrolled hypertension/diabetes mellitus, active malignant tumors)
- •6: A history of recurrent implantation failure (≥2 cycles) or recurrent miscarriage (≥2 episodes)
结局指标
主要结局
Live birth rate
时间窗: From enrollment to the delivery (≥28 weeks of gestation)
Live birth rate is defined as the proportion of all enrolled participants who achieved a live birth, defined as the delivery of a live infant at ≥28 weeks of gestation with any signs of life (e.g., heartbeat, respiration).
次要结局
- Ongoing pregnancy rate(From enrollment to 12 weeks of gestation)
- Miscarriage rate(From enrollment to 28 weeks of gestation)
- Biochemical pregnancy rate(From enrollment to 12 days (blastocyst), 14 days (D3), or 15 days (D2) after embryo transfer)
- Ectopic pregnancy rate(From enrollment to 28 days after embryo transfer)
- Neonatal complication rate(From enrollment to 1 month after delivery)
- Macrosomia rate(From enrollment to the delivery)
- Low birth weight rate(From enrollment to the delivery)
- Clinical pregnancy rate(From enrollment to 28 days after embryo transfer)
- Preterm birth rate(From enrollment to the delivery)
- Implantation rate(From enrollment to 28 days after embryo transfer)
- Congenital malformation rate(From enrollment to 1 month after delivery)
- Multiple pregnancy rate(From enrollment to 28 days after embryo transfer)