NCT05564312

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

September 29, 2022

Last Update Submit

May 20, 2023

Conditions

Keywords

air bubble positionembryo transferultrasonographic guidance

Outcome Measures

Primary Outcomes (1)

  • Positive β-hCG results

    Positive β-hCG results nine days after embryo transfer.

    Nine days after each embryo transfer

Study Arms (2)

non-pregnant

Negative b-hCG results 9 days after embryo transfer.

Device: Transabdominal ultrasonographic guidance at embryo transfer.

pregnant

Positive b-hCG results 9 days after embryo transfer.

Device: Transabdominal ultrasonographic guidance at embryo transfer.

Interventions

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.

non-pregnantpregnant

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, 07700, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • ŞAFAK OLGAN, MD

    Akdeniz University

    PRINCIPAL INVESTIGATOR
  • ARİF C ÖZSİPAHİ, MD

    Akdeniz University

    STUDY CHAIR

Central Study Contacts

ŞAFAK OLGAN, MD

CONTACT

ARİF C ÖZSİPAHİ, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 3, 2022

Study Start

December 1, 2021

Primary Completion

August 1, 2023

Study Completion

December 31, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations