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

NCT ID: NCT05564312

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-12-31

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.

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.

Conditions

Infertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

non-pregnant

Negative b-hCG results 9 days after embryo transfer.

Transabdominal ultrasonographic guidance at embryo transfer.

Intervention Type: DEVICE

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.

Transabdominal ultrasonographic guidance at embryo transfer.

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

ŞAFAK OLGAN

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ŞAFAK OLGAN, MD

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

ARİF C ÖZSİPAHİ, MD

Role: STUDY_CHAIR

Akdeniz University

Locations

Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

ŞAFAK OLGAN, MD

Role: CONTACT

safakolgan@gmail.com

00905064068740

ARİF C ÖZSİPAHİ, MD

Role: CONTACT

a.canozsipahi@hotmail.com

005068301073

Facility Contacts

Şafak Olgan, MD

Role: primary

safakolgan@gmail.com

+905064068740

Arif C Özsipahi, MD

Role: backup

a.canozsipahi@hotmail.com

+905068301073

Other Identifiers

49829699

Identifier Type: -

Identifier Source: org_study_id