The Effect of Embryo Transfer Technique on Pregnancy Outcomes in HRT-FET Cycles

The Effect of Embryo Transfer Technique on Pregnancy Outcomes in HRT-FET Cycles Using High-Quality Blastocyst Stage Embryos: a Prospective Cohort Study

The positions of the air bubble and the tip of catheter will be measured by transabdominal utrasonography among patients who have undergone high-quality frozen blastocyst transfer. The aim of this study is to compare pregnancy rates according to air bubble's final location in endometrial cavity. It is expected that the ET technique will be improved and live birth rates will increase by determining the optimal position of the embryo in the endometrial cavity during ET in patients who have achieved pregnancy.

Study Overview

• Status: Recruiting
• Conditions: Infertility
• Intervention / Treatment: Device: Transabdominal ultrasonographic guidance at embryo transfer.

Detailed Description

Only patients who have high-quality blastocyst stage embryos will be included in the study. Since the implantation potential of high-quality embryos is high, possible embryo-induced implantation failure will be minimized. The positions of the air bubble and the catheter in the endometrial cavity in patients with and without pregnancy will be compared.

In patients participating in the study, the transfer catheter will be loaded using a "three drop technique," in which the drop of medium containing the embryo(s) is/are separated from a preceding and a following drop of the medium by an air bubble.

In hormonally prepared frozen embryo cycles, during embryo transfer in each patient, endometrial thickness, uterine cavity dimensions, distance of transfer catheter to the fundus, distance of released air bubble to the fundus, and distance of air bubble to side walls will be systematically measured and recorded under the guidance of transabdominal ultrasonography.

If the position of the embryo in the endometrial cavity is determined during ET in patients who have achieved pregnancy, an ET technique can be defined that predicts the optimum for the physician who will perform the transfer. Therefore, an increase in implantation and pregnancy rates can be achieved.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: ŞAFAK OLGAN, MD; Phone Number: 00905064068740; Email: safakolgan@gmail.com
• Study Contact Backup: Name: ARİF C ÖZSİPAHİ, MD; Phone Number: 005068301073; Email: a.canozsipahi@hotmail.com

Study Locations

• Turkey
  • Antalya, Turkey, 07700
    • Recruiting
    • Akdeniz University
    • Contact: Şafak Olgan, MD; Phone Number: +905064068740; Email: safakolgan@gmail.com
    • Contact: Arif C Özsipahi, MD; Phone Number: +905068301073; Email: a.canozsipahi@hotmail.com
    • Principal Investigator: Şafak Olgan, MD
    • Sub-Investigator: Arif C Özsipahi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

All patients who have artificial endometrial preparation with high-quality blastocysts between December 2021 and December 2022 will be included.

Description

Inclusion Criteria:

• Exogenous hormone preparation of the endometrial lining
• High embryo quality ((≥2BB) according to Alpha criteria
• Embryo transfer at the blastocyst stage

Exclusion Criteria:

• Patients whose treatments were canceled for any reason before the embryo transfer procedure
• Patients who underwent embryo transfer in the cleavage stage
• Presence of low-quality (<2BB) blastocysts
• >15% loss of viability of the embryo during embryo thawing,
• Patients with congenital uterine malformations,

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-pregnant; Negative b-hCG results 9 days after embryo transfer.	Device: Transabdominal ultrasonographic guidance at embryo transfer.; During embryo transfer in each patient, endometrial thickness, uterine cavity dimensions, distance of transfer catheter to the fundus, distance of released air bubble to the fundus, and distance of air bubble to side walls will be systematically measured and recorded under the guidance of transabdominal ultrasonography.
pregnant; Positive b-hCG results 9 days after embryo transfer.	Device: Transabdominal ultrasonographic guidance at embryo transfer.; During embryo transfer in each patient, endometrial thickness, uterine cavity dimensions, distance of transfer catheter to the fundus, distance of released air bubble to the fundus, and distance of air bubble to side walls will be systematically measured and recorded under the guidance of transabdominal ultrasonography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive β-hCG results	Positive β-hCG results nine days after embryo transfer.	Nine days after each embryo transfer

Collaborators and Investigators

• Sponsor: Akdeniz University
• Investigators: Principal Investigator: ŞAFAK OLGAN, MD, Akdeniz University; Study Chair: ARİF C ÖZSİPAHİ, MD, Akdeniz University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 20, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: embryo transfer; air bubble position; ultrasonographic guidance
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 49829699

Drug and device information, study documents

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