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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05510557
• Other study ID #: 49849695
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: May 2023
• Source: Akdeniz University
• Contact: Safak Olgan, MD
• Phone: +905064068740
• Email: safakolgan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 30, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live Birth Rate	pregnancy beyond 24 weeks of gestational age.	9 months
Primary	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