Comparison of Two Different Catheter Withdrawal Technique
NCT ID: NCT03097042
Last Updated: 2018-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
200 participants
INTERVENTIONAL
2017-02-01
2017-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study group
The catheter will be pulled back slowly and without rotation
Embryo transfer with catheter Manipulation
catheter rotation during withdrawal
Control Group
The catheter will be pulled back by rotating 360 degrees round itself
Embryo transfer any further manipulation
The catheter will be pulled back slowly and without rotation with the plunger still pushed forward
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Embryo transfer any further manipulation
The catheter will be pulled back slowly and without rotation with the plunger still pushed forward
Embryo transfer with catheter Manipulation
catheter rotation during withdrawal
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
20 Years
40 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Çiğdem Yayla Abide
MD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zeynep Kamil Hospital
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yayla Abide C, Ozkaya E, Sanverdi I, Bostanci Ergen E, Kurek Eken M, Devranoglu B, Bilgic BE, Kilicci C, Kayatas Eser S. Prospective Randomized Trial Comparing Embryo Transfers of Cases with and without Catheter Rotation during Its Withdrawal. Gynecol Obstet Invest. 2018;83(4):397-403. doi: 10.1159/000489493. Epub 2018 May 14.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
180/2016
Identifier Type: -
Identifier Source: org_study_id