Prospective Randomized Controlled Trial Comparing Catheter Rotation and no Rotation During Embryo Transfer on Pregnancy Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Clinical Pregnancy Rate
研究概览
简要总结
The goal of this clinical trial was to determine whether rotating the embryo transfer catheter through 360° during its withdrawal improves pregnancy outcomes in women aged 20-35 years undergoing fresh day-3 embryo transfer as part of assisted reproductive treatment. The main questions it aimed to answer were:
Does 360° catheter rotation during withdrawal increase the clinical pregnancy rate, defined as the ultrasound confirmation of an intrauterine gestational sac? Does 360° catheter rotation during withdrawal increase the chemical pregnancy rate, defined by a positive pregnancy test?
Researchers compared embryo transfer with 360° catheter rotation during catheter withdrawal with embryo transfer without catheter rotation to determine whether this technique improves pregnancy outcomes.
Participants were:
Undergoing controlled ovarian stimulation, oocyte retrieval, fertilization, and fresh transfer of two day-3 embryos.
Being randomly assigned to either 360° catheter rotation during withdrawal or standard catheter withdrawal without rotation.
Undergoing pregnancy testing after embryo transfer. Undergoing an ultrasound examination to confirm clinical pregnancy if the pregnancy test was positive.
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 (Participant)
盲法说明
Participants were blinded to their assigned study group. The clinician performing the embryo transfer was not blinded because the assigned catheter withdrawal technique had to be performed during the procedure.
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20-35 years. Body mass index (BMI) less than 40 kg/m². Undergoing fresh day-3 embryo transfer. First embryo transfer cycle. Transfer of two grade A embryos. Willingness to participate and provision of written informed consent.
排除标准
- •Diabetes mellitus, hypertension, thyroid disorders, or other significant systemic diseases.
- •Male-factor infertility. Endometriosis. Uterine-factor infertility, including uterine fibroids, adenomyosis, uterine septum, cesarean scar niche, or endometrial polyps.
- •Difficult embryo transfer. Poor ovarian response.
研究组 & 干预措施
360° Catheter Rotation
During embryo transfer, the catheter was withdrawn using a controlled 360° rotational movement.
干预措施: Embryo Transfer Catheter Withdrawal Technique (Procedure)
No Catheter Rotation
During embryo transfer, the catheter was withdrawn directly without rotational movement.
干预措施: Embryo Transfer Catheter Withdrawal Technique (Procedure)
结局指标
主要结局
Clinical Pregnancy Rate
时间窗: Approximately 4-5 weeks after embryo transfer
The proportion of participants with an intrauterine gestational sac confirmed by transvaginal ultrasound after embryo transfer. Clinical pregnancy rate was calculated as the number of participants with a confirmed clinical pregnancy divided by the total number of participants in each study arm, multiplied by 100.
次要结局
- Chemical Pregnancy Rate(Approximately 14 days after embryo transfer)
研究者
Ahmed Mohamed Elmoustafa Hussein Mahmoud Abdelkarim
Dr
Kafrelsheikh University