Does the Embryo Transfer Technique Affect the Success of in Vitro Fertilization?

Comparison of IVF Success Rates Between Different Embryo Transfer Techniques: Afterload Technique and Trial Followed by Transfer Technique

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

Study Overview

• Status: Recruiting
• Conditions: Infertility; IVF; Assisted Reproductive Technology
• Intervention / Treatment: Procedure: Afterload Transfer; Procedure: Trial followed by transfer

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

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elif Esra Uyar, MD; Phone Number: +902166494444; Email: esra.uyar@acibadem.com

Study Locations

• Turkey
  • İstanbul, Turkey, 34662
    • Recruiting
    • Acibadem Altunizade Hospital, Unit of ART
    • Contact: Elif Esra Uyar, MD; Phone Number: +902166494444; Email: esra.uyar@acibadem.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Patient has given written informed consent
2. BMI 18-30 kg/m2
3. < 2 previous failed IVF trials
4. At least two good quality embryos on the day of transfer

Exclusion Criteria:

1. Congenital uterine anomaly
2. Untreated endometrial polyp or fibroid distorting uterine cavity
3. Presence of hydrosalpinx 4.2 or more prior IVF trial failure

5.Moderate to severe endometriosis 6.Recurrent pregnancy loss history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Afterload transfer; 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.	Procedure: Afterload Transfer; Embryo transfer is done by using "afterload transfer" method
Experimental: Trial Followed by Transfer; 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	Procedure: Trial followed by transfer; Embryo transfer is done by using "afterload transfer" method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	the presence of gestational sac on ultrasound	5-6 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implantation rate	the number of gestational sacs divided by the number of embryos transferred	3-4 weeks after embryo transfer

Collaborators and Investigators

• Sponsor: Acibadem Kadiköy Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 21, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: AcibademKD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No