Comparison of Two Different Catheter Withdrawal Technique
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2017
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedFirst Posted
Study publicly available on registry
March 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2017
CompletedJanuary 31, 2018
January 1, 2018
6 months
January 24, 2017
January 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Pregnancy
Detection of the fetal heart rate by ultrasonography
6 months
Secondary Outcomes (1)
mucus or blood stained catheter
6 months
Study Arms (2)
Study group
ACTIVE COMPARATORThe catheter will be pulled back slowly and without rotation
Control Group
ACTIVE COMPARATORThe catheter will be pulled back by rotating 360 degrees round itself
Interventions
The catheter will be pulled back slowly and without rotation with the plunger still pushed forward
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zeynep Kamil Hospital
Istanbul, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 29758560DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 24, 2017
First Posted
March 31, 2017
Study Start
February 1, 2017
Primary Completion
August 1, 2017
Study Completion
August 31, 2017
Last Updated
January 31, 2018
Record last verified: 2018-01