Evaluation of Blastocyst Morphology and Quality in Patients With Embryo Transfer at the Blastocyst Stage

Sponsor
Akdeniz University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05510557
Collaborator
(none)
500
1
11
45.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effect of Blastocyst Morphology and Quality on Obstetric Outcomes in Patients Who Underwent Frozen Embryo Transfer at the Blastocyst Stage: Prospective Cohort Study
    Actual Study Start Date :
    May 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Mar 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Live Birth Rate [9 months]

      pregnancy beyond 24 weeks of gestational age.

    2. Obstetric Complication Rates [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Akdeniz University Antalya Turkey 07700

    Sponsors and Collaborators

    • Akdeniz University

    Investigators

    • Principal Investigator: Şafak Olgan, MD, 1
    • Study Chair: Arif C Özsipahi, MD, 2

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ŞAFAK OLGAN, Associate Professor, Akdeniz University
    ClinicalTrials.gov Identifier:
    NCT05510557
    Other Study ID Numbers:
    • 49849695
    First Posted:
    Aug 22, 2022
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ŞAFAK OLGAN, Associate Professor, Akdeniz University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2022