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临床试验/NCT03292770
NCT03292770已完成不适用

EFFICACY STUDY OF THE UTILIZATION OF A FLUSHING CATHETER FOR REMOVAL OF CERVICAL MUCUS BEFORE AN EMBRYO TRANSFER: A RANDOMIZED PILOT CONTROLLED TRIAL

Institut Universitari Dexeus1 个研究点 分布在 1 个国家目标入组 1,118 人开始时间: 2017年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,118
试验地点
1
主要终点
Clinical Pregnancy Rate

研究概览

简要总结

Despite these revolutionary changes in the laboratory, little has changed with the process of embryo transfer (ET). A study to prospectively evaluate the role of cervical mucus removal prior to embryo transfer on pregnancy rates in ART will be undertaken.

详细描述

ET involves placing the embryo(s) obtained before assisted reproduction technology (ART) into the uterus via a catheter advanced through the cervical canal. Yet this is the final, and in some respects the most critical, process in the sequential events that encompass an ART cycle. If an embryo cannot be delivered to the uterine cavity atraumatically and in a location for optimal implantation, the steps of ovarian hyperstimulation, oocyte retrieval, embryo culture, and embryo selection will have no benefit. Contamination of the catheter with blood may be a marker for difficult ET and has also been linked to poor ET outcomes. When retrospectively assessing outcomes, Goudas et al. (1) demonstrated a clinical pregnancy rate of 50% with no blood, and this rate fell by half when a small amount of blood was noted on the catheter tip. Pregnancy rates fell even further, to 10%, when there was a significant amount of blood (1). Similarly, in a preliminary study, blood or mucus on the tip was associated with a significantly lower pregnancy outcome (2). Blood and mucus were associated with an increased risk for unsuccessful transfers with odds ratios of 1.9 and 1.8, respectively. Although all these data suggest a possible role of cervical mucus in embryo transfer, there is no clinical evidence on the effect of removal of cervical mucus on the outcome of IVF/ICSI. In view of this uncertainty, a study to prospectively evaluate the role of cervical mucus removal prior to embryo transfer on pregnancy rates in ART will be undertaken. It is hypothesized that removal of cervical mucus will achieve higher clinical pregnancy rates.

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
Double (Participant, Outcomes Assessor)

盲法说明

All included patients will be blinded of the procedure.

入排标准

年龄范围
— 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •IVF or OD patients with supernumerary embryos (oocyte's age will be considered as patient's age).
  • •Normal transvaginal ultrasound at screening, without evidence of clinically significant abnormality consistent with finding adequate for ART with respect to uterus and adnexa
  • •Single embryo transfer
  • •Embryo transfer at the blastocyst stage
  • •Embryo with a morphological classification of ≥3BB

排除标准

  • •Preimplantation genetic diagnosis and/or screening

研究组 & 干预措施

Control Group

No Intervention

Embryo transfer will be performed as per clinic's routine protocol, where cervical mucus is gently removed with a cotton swab. No manipulation of the cervical canal is executed.

Flushing Group

Experimental

A catheter will be used to perform a flushing of the cervical canal with culture media. The Flushing Catheter has a flared proximal end that is designed to affix to a standard Luer slip syringe and a pre-curved distal closed end, with a biseled opening on the side, 2mm from the tip, in which liquid flushes towards the outside of the cervical canal.

Device: Cook Flushing Catheter J-IUIC-352200 (3.5fr 20cm flushing catheter with positioner closed end) (CEE approval).

干预措施: Flushing Catheter (Device)

结局指标

主要结局

Clinical Pregnancy Rate

时间窗: 20 days after embryo transfer

Defined as the proportion of patients with a gestational sac seen 20 days after embryo transfer

次要结局

  • Biochemical Pregnancy Rate(9 days after embryo transfer)
  • Early Pregnancy Loss Rate(20 days after embryo transfer)

研究者

发起方
Institut Universitari Dexeus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jorge Rodriguez-Purata

Dr. Jorge Rodriguez-Purata

Institut Universitari Dexeus

研究点 (1)

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