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临床试验/NCT03097042
NCT03097042已完成不适用

Comparison of Two Different Catheter Withdrawal Technique During Embryo Transfer

Zeynep Kamil Maternity and Pediatric Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年2月1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
200
试验地点
1
主要终点
Clinical Pregnancy

研究概览

简要总结

The embryologist will oad the embryos into the catheter at the right position, then the catheter will be slowly pushed through the cervical canal, 1-2 cm beneath the fundus 5.5 cm away from the cervical external os.The embryos will be delivered by pushing the plunger of the syringe from the mid-cavitary positioned catheter and keeping the plunger pushed down.

Study Group: The catheter will be pulled back slowly and without rotation with the plunger still pushed forward.

Control Group: The catheter will be pulled back slowly with a 360°rotation with the plunger kept pushed forward.

详细描述

Patients to be included will be those meeting the study criteria who present at Istanbul Zeynep Kamil Training and Research Hospital, In vitro fertilization unit between February 1, 2017 and August, 2017.

The voluntary participants of the study will undergo controlled ovarian stimulation that is routinely performed in our clinic, followed by ovum pick up (OPU) and embryo transfer procedure. Volunteers will be asked to hold the urine 2 hours before the procedure to ensure fullness of the bladder. Identification details will be checked to verify that the names on the embryo containers are correct. The embryos will be examined by the embryologist. The participants will be informed before the procedure about the fertilization rates, number and quality of the developed embryos, the number of embryos to be transferred and the number of embryos planned to be frozen. Patients will undergo the procedure in the lithotomy position.The fullness of the bladder will be verified by inserting a speculum cervix and the vagina will be cleaned with a sterile serum physiological saline solution (SF) sponge, and cervical mucus aspired from the external os gently with a special soft aspirator catheter.

After the cervix is cleaned with culture liquid, a trial transfer will be performed with a sterile catheter. At this stage, only the soft internal catheter will pass through the internal os and the outer sheath will be stopped when it reaches the internal os. The outer sheath of the catheter will be advanced 2 cm into the cervical canal under ultrasound guidance and will be stopped before passing the internal os. Once it is ensured that the soft catheter is inside the endometrial cavity, the embryologist will be informed of the appropriate catheter position. Embryologist will oad the embryos into the catheter at the right position, then the catheter will be slowly pushed through the cervical canal, 1-2 cm beneath the fundus 5.5 cm away from the cervical external os. The embryos will be delivered by pushing the plunger of the syringe from the mid-cavitary positioned catheter and keeping the plunger pushed down. Afterwards, the volunteers will be randomly divided into two groups. Randomization will be ensured by a computer-based programme.

  • 1st Group Volunteers: The catheter will be pulled back slowly and without rotation with the plunger still pushed forward.
  • 2nd GroupVolunteers:The catheter will be pulled back slowly with a 360° rotation with the plunger kept pushed forward. The speculum will remain in the cervix until the embryologist checks the catheter for the presence of any embryos, blood or mucus.

Parameters to be Reviewed: Age, weight, height of the participants, primary/secondary infertility, infertility duration, presence of additional diseases, gravida, parity, abortion history, endometrial thickness on the day of HCG, infertility reasons, baseline and total gonadotropin dose, stimulation period, number of collected oocytes, number of M2 oocytes, quality of transferred embryos, BhCG positivity

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
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Volunteers between the ages 20 to 40 Good quality embryo transfer Easy embryo transfer (use of soft catheter, not using tenaculum), Fresh cycle Single embryo transfer

排除标准

  • •Volunteers younger than 20 and older than 40 years old Volunteers with poor ovarian reserve Low quality embryos Difficult embryo transfer (use of rigid catheter, use of tenaculum, passing of outer catheters heath from cervical os) Frozen cycle Volunteers that receive another transfer of embryos that remain in the catheter after the initial transfer.

研究组 & 干预措施

Study group

Active Comparator

The catheter will be pulled back slowly and without rotation

干预措施: Embryo transfer with catheter Manipulation (Procedure)

Control Group

Active Comparator

The catheter will be pulled back by rotating 360 degrees round itself

干预措施: Embryo transfer any further manipulation (Procedure)

结局指标

主要结局

Clinical Pregnancy

时间窗: 6 months

Detection of the fetal heart rate by ultrasonography

次要结局

  • mucus or blood stained catheter(6 months)

研究者

发起方
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Çiğdem Yayla Abide

MD

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

研究点 (1)

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