Comparison of Two Different Catheter Withdrawal Technique
Condition: Embryo; Catheter Site Discharge
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Embryo transfer any further manipulation; Embryo transfer with catheter Manipulation
Intervention type(s): Procedure; Procedure
Intervention description(s): The catheter will be pulled back slowly and without rotation with the plunger still pushed forward; catheter rotation during withdrawal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment