NCT05510557

Brief Summary

In this prospective study, the investigators aim to investigate the role of trophectoderm cells and inner cell mass cells on pregnancy outcomes in blastocyst transferred in-vitro fertilization pregnancy. The investigators will support findings with bilateral uterine artery Doppler measurements to be made between the 11th and 14th weeks of 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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 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

May 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

August 19, 2022

Last Update Submit

May 20, 2023

Conditions

Infertility

Keywords

Embryo MorphologyFrozen - thawed embryo transfer

Outcome Measures

Primary Outcomes (2)

  • Live Birth Rate

    pregnancy beyond 24 weeks of gestational age.

    9 months

  • Obstetric Complication Rates

    Conditions such as preeclampsia, eclampsia, fetal growth restriction, oligohydramnios, polyhydramnios, preterm birth, gestational diabetes mellitus, antenatal bleeding and etc. that develop during pregnancy

    20 weeks after embryo transfer

Eligibility Criteria

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

All patients aged 18-40 years who underwent a single freeze-thaw transfer on the 5th day in Akdeniz University Hospital Center for Reproductive Endocrinology and Assisted Reproduction between May 2022 and December 2022 will be included in the study.

You may qualify if:

  • Exogenous hormone preparation of the endometrial lining
  • Single embryo transfer
  • Embryo transfer at the blastocyst stage

You may not qualify if:

  • Double embryo transfer
  • Patients who underwent embryo transfer at the cleavage stage
  • \>15% loss of embryo viability during embryo thawing
  • Patients whose data could not be accessed after follow-up or delivery

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

    1

    PRINCIPAL INVESTIGATOR

  • Arif C Özsipahi, MD

    2

    STUDY CHAIR

Central Study Contacts

Şafak Olgan, MD

CONTACT

+905064068740safakolgan@gmail.com

Arif C Özsipahi, MD

CONTACT

+905068301073a.canozsipahi@hotmail.com

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

August 19, 2022

First Posted

August 22, 2022

Study Start

May 1, 2022

Primary Completion

July 31, 2023

Study Completion

November 30, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations

TU(1)