NCT05474833

Brief Summary

In this prospective study, the possible effects of embryo viability and degree of blastocele re-expansion on pregnancy outcomes before vitrified/thawed blastocyst transfer will be evaluated.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

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

March 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

July 23, 2022

Last Update Submit

May 20, 2023

Conditions

Infertility

Keywords

Embryo morphologyEmbryo re-expansionFrozen- thawed embryo transfer

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    In ultrasonography evaluation three weeks after a positive pregnancy result, a clinical pregnancy will be considered in patients with a fetal heartbeat.

    Three weeks after each positive pregnancy test result

Secondary Outcomes (3)

  • Positive β-hCG results

    Nine days after each embryo transfer

  • The effect of re-expansion degrees and viability of embryos on pregnancy

    Three weeks after each positive pregnancy test result

  • Optimal time between two assessments of expansion

    About 2 hours between thawing and transfer

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients underwent infertility treatment
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women between the ages of 18 and 40 who underwent IVF treatment

You may qualify if:

  • Women aged 18-40 years
  • Frozen- thawed embryo transfer cycles
  • Only the cycles prepared artificially with hormone replacement therapy.
  • Embryos with Day 5 (1CC and higher quality)

You may not qualify if:

  • Embryos at the cleavage stage (D3)
  • Patients for whom embryo viability and expansion were not evaluated single-blindly by two different embryologists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • ŞAFAK OLGAN, 1

    Akdeniz University

    PRINCIPAL INVESTIGATOR

  • ARİF C ÖZSİPAHİ, 2

    Akdeniz University

    STUDY CHAIR

  • SEFA M CEYLAN, 2

    Akdeniz University

    STUDY CHAIR

Central Study Contacts

ŞAFAK OLGAN, 1

CONTACT

00905064068740safakolgan@gmail.com

ARİF C ÖZSİPAHİ, 2

CONTACT

005068301073a.canozsipahi@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

July 23, 2022

First Posted

July 26, 2022

Study Start

March 1, 2022

Primary Completion

December 1, 2023

Study Completion

February 1, 2024

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations

TU(1)