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Clinical Trials/NCT05510557
NCT05510557
Recruiting
Not Applicable

The Effect of Blastocyst Morphology and Quality on Obstetric Outcomes in Patients Who Underwent Frozen Embryo Transfer at the Blastocyst Stage: Prospective Cohort Study

Akdeniz University1 site in 1 country500 target enrollmentMay 1, 2022
ConditionsInfertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility
Sponsor
Akdeniz University
Enrollment
500
Locations
1
Primary Endpoint
Live Birth Rate
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Detailed Description

Patients scheduled for thawed blastocyst transfer between May 2022 and December 2022 in Akdeniz University Hospital Center for Reproductive Endocrinology and Assisted Reproduction will be included in the study. Embryos that have reached the Blastocyst stage after the ICSI procedure will be examined by a single experienced embryologist using the ALPHA Istanbul consensus evaluation system. This system includes separating the blastocyst from the zona pellucida - hatching (Grade 1,2,3,4), the size of ICM and arrangement (grade A, B, C), and the number of TE cells and arrangement (grade A, B, C). Among the embryos whose quality is determined, the best quality embryo belonging to the patient will be transferred single, patients who develop pregnancy after the transfer will be called for follow-ups for uterine artery Doppler measurements to evaluate uteroplacental flow between 11and 14 weeks, and their Doppler measurements will be recorded. By contacting the patients with the phone numbers recorded at the time of the first visit, the weeks of birth, baby weight, gender, and complications that developed during the pregnancy (Abortion, Preeclampsia, Eclampsia, Fetal Growth Restriction, Oligohydramnios, Polyhydramnios, Gestational Diabetes Mellitus and Antenatal Bleeding) will be recorded. In case the related relationship can be revealed, the risk situations in terms of complications are determined before the transfer, and it is aimed to increase the number of live births together with the risk-based management in the follow-up and screening programs.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
November 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ŞAFAK OLGAN

Associate Professor

Akdeniz University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Live Birth Rate

Time Frame: 9 months

pregnancy beyond 24 weeks of gestational age.

Obstetric Complication Rates

Time Frame: 20 weeks after embryo transfer

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

Study Sites (1)

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