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

Sponsor
Akdeniz University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05564312
Collaborator
(none)
600
1
14.9
40.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Embryo Transfer Technique on Pregnancy Outcomes in HRT-FET Cycles Using High-Quality Blastocyst Stage Embryos: a Prospective Cohort Study
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Positive β-hCG results [Nine days after each embryo transfer]

    Positive β-hCG results nine days after embryo transfer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
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,

Contacts and Locations

Locations

Site City State Country Postal Code
1 Akdeniz University Antalya Turkey 07700

Sponsors and Collaborators

  • Akdeniz University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ŞAFAK OLGAN, Associate Professor, Akdeniz University
ClinicalTrials.gov Identifier:
NCT05564312
Other Study ID Numbers:
  • 49829699
First Posted:
Oct 3, 2022
Last Update Posted:
Oct 3, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ŞAFAK OLGAN, Associate Professor, Akdeniz University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 3, 2022