Back to resultsDoes the Embryo Transfer Technique Affect the Success of in Vitro Fertilization?
Primary Purpose
Infertility, Assisted Reproductive Technology, IVF
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Afterload Transfer
Trial followed by transfer
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Patient has given written informed consent
- BMI 18-30 kg/m2
- < 2 previous failed IVF trials
- At least two good quality embryos on the day of transfer
Exclusion Criteria:
- Congenital uterine anomaly
- Untreated endometrial polyp or fibroid distorting uterine cavity
- Presence of hydrosalpinx 4.2 or more prior IVF trial failure
5.Moderate to severe endometriosis 6.Recurrent pregnancy loss history
Sites / Locations
- Acibadem Altunizade Hospital, Unit of ARTRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Afterload transfer
Trial Followed by Transfer
Arm Description
First, an empty catheter passes to the level of the lower uterine segment under ultrasound guidance to a point where the inner catheter enters the endometrial cavity. The inner sheath is removed slowly, leaving the outer sheath just beyond the internal os. After verifying the catheter's position on the TA ultrasound scan, the physician gives the signal to the embryologist to start the embryo loading. The embryologist brings the loaded inner catheter and inserts it into the outer sheath, which is maintained in its position by the physician.
First a trial transfer is performed using both the inner catheter and outer sheath connected together in standard configuration, just before the actual embryo transfer. It is passed up to and just through the the internal os. When it appears that the actual transfer will be possible without great difficulty ,the trial catheter is withdrawn. An embryo transfer catheter is loaded and the actual transfer is performed
Outcomes
Primary Outcome Measures
clinical pregnancy rate
the presence of gestational sac on ultrasound
Secondary Outcome Measures
implantation rate
the number of gestational sacs divided by the number of embryos transferred
Full Information
NCT ID
NCT03756857
First Posted
November 27, 2018
Last Updated
March 21, 2021
Sponsor
Acibadem Kadiköy Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03756857
Brief Title
Does the Embryo Transfer Technique Affect the Success of in Vitro Fertilization?
Official Title
Comparison of IVF Success Rates Between Different Embryo Transfer Techniques: Afterload Technique and Trial Followed by Transfer Technique
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem Kadiköy Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective, open, randomized, parallel, two-arm trial to compare the clinical pregnancy rate between most commonly used two embryo transfer techniques: trial followed by transfer technique and afterloading technique
Detailed Description
Eligible patients will be informed about the possibility of participating in the clinical trial in the beginning of treatment and on the day ET, a signed consent form will be collected from those recipients who confirmed their participation. These patients will be randomized immediately before the ET procedure by sequentially numbered, opaque, sealed envelopes
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Assisted Reproductive Technology, IVF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, open, randomized, parallel, two-arm trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Afterload transfer
Arm Type
Experimental
Arm Description
First, an empty catheter passes to the level of the lower uterine segment under ultrasound guidance to a point where the inner catheter enters the endometrial cavity. The inner sheath is removed slowly, leaving the outer sheath just beyond the internal os. After verifying the catheter's position on the TA ultrasound scan, the physician gives the signal to the embryologist to start the embryo loading. The embryologist brings the loaded inner catheter and inserts it into the outer sheath, which is maintained in its position by the physician.
Arm Title
Trial Followed by Transfer
Arm Type
Experimental
Arm Description
First a trial transfer is performed using both the inner catheter and outer sheath connected together in standard configuration, just before the actual embryo transfer. It is passed up to and just through the the internal os. When it appears that the actual transfer will be possible without great difficulty ,the trial catheter is withdrawn. An embryo transfer catheter is loaded and the actual transfer is performed
Intervention Type
Procedure
Intervention Name(s)
Afterload Transfer
Intervention Description
Embryo transfer is done by using "afterload transfer" method
Intervention Type
Procedure
Intervention Name(s)
Trial followed by transfer
Intervention Description
Embryo transfer is done by using "afterload transfer" method
Primary Outcome Measure Information:
Title
clinical pregnancy rate
Description
the presence of gestational sac on ultrasound
Time Frame
5-6 weeks after embryo transfer
Secondary Outcome Measure Information:
Title
implantation rate
Description
the number of gestational sacs divided by the number of embryos transferred
Time Frame
3-4 weeks after embryo transfer
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient has given written informed consent
BMI 18-30 kg/m2
< 2 previous failed IVF trials
At least two good quality embryos on the day of transfer
Exclusion Criteria:
Congenital uterine anomaly
Untreated endometrial polyp or fibroid distorting uterine cavity
Presence of hydrosalpinx 4.2 or more prior IVF trial failure
5.Moderate to severe endometriosis 6.Recurrent pregnancy loss history
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elif Esra UYAR, MD
Phone
+902166494444
Email
esra.uyar@acibadem.com
Facility Information:
Facility Name
Acibadem Altunizade Hospital, Unit of ART
City
İstanbul
ZIP/Postal Code
34662
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elif Esra Uyar, MD
Phone
+902166494444
Email
esra.uyar@acibadem.com
12. IPD Sharing Statement
Learn more about this trial
Does the Embryo Transfer Technique Affect the Success of in Vitro Fertilization?
We'll reach out to this number within 24 hrs