Baseline and First Trimester Uterine Artery Doppler Velocimetry to Predict Poor Obstetric Outcomes in IVF

NCT ID: NCT05661539

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-04-15

Brief Summary

The researchers aim to determine how baseline (preconceptional) and first-trimester uterine artery Doppler measurements affect obstetric complications in women undergoing high-quality blastocyst transfer and to determine the correlation between the two Doppler measurements.

Detailed Description

Only patients with high-quality blastocyst-stage embryos will be included in the study. In frozen embryo transfer cycles prepared hormonally, basal bilateral uterine artery Doppler velocimetry will be performed before treatment (preconception) in each patient.

Bilateral uterine artery Doppler velocimetry will be performed during the basal ultrasonography (2-5 days of menstruation). The absence of any uterine artery notches, diastolic or reverse flow will also be noted. In addition, sub-endometrial (arcuate artery) blood flows will be evaluated by Doppler ultrasonography.

For endometrial preparation, estrogen replacement will be given for approximately 12-14 days as a routine In cases with endometrial thickness ≥7mm, progesterone treatment will be started and embryo transfer will be planned on the 6th day of the treatment.

In the pregnant group, measurements will be repeated at the end of the first trimester (11-14 weeks) and uterine artery Doppler velocimetry will be reevaluated. In addition, patients will be followed up until delivery and possible obstetric complications will be recorded.

Baseline and first-trimester uterine artery Doppler ultrasonography findings will be compared with obstetric results. Obstetric outcomes such as birth weight at the end of pregnancy, small-large for gestational age, presence of hypertension, and preterm delivery will be correlated with preconceptional and first-trimester uterine artery Doppler parameters.

Conditions

Infertility, Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

non-pregnant

negative b-hCG results 9 days after embryo transfer.

Transvaginal Ultrasonography

Intervention Type: DEVICE

The amount of resistance and blood flow in the main arteries that provide uterine perfusion will be determined by uterine artery Doppler velocimetry performed on the patients.

pregnant with obstetric complications

Patients with a positive pregnancy result who develop obstetric complications such as preeclampsia, eclampsia, fetal growth restriction, oligohydramnios, polyhydramnios, preterm birth, gestational diabetes mellitus, antenatal bleeding and etc. after the 20th gestational weeks.

Transvaginal Ultrasonography

Intervention Type: DEVICE

The amount of resistance and blood flow in the main arteries that provide uterine perfusion will be determined by uterine artery Doppler velocimetry performed on the patients.

pregnant without obstetric complications

Patients who have positive pregnancy results and do not have any obstetric complications such as preeclampsia, eclampsia, fetal growth restriction, oligohydramnios, polyhydramnios, preterm birth, gestational diabetes mellitus, antenatal bleeding and etc. during pregnancy.

Transvaginal Ultrasonography

Intervention Type: DEVICE

The amount of resistance and blood flow in the main arteries that provide uterine perfusion will be determined by uterine artery Doppler velocimetry performed on the patients.

Interventions

Transvaginal Ultrasonography

The amount of resistance and blood flow in the main arteries that provide uterine perfusion will be determined by uterine artery Doppler velocimetry performed on the patients.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Exogenous hormone preparation of the endometrial lining
• High embryo quality ((≥2BB) according to Alpha criteria
• Embryo transfer at the blastocyst stage

Exclusion Criteria

• Patients whose treatments were canceled for any reason before the embryo transfer procedure
• Patients who underwent embryo transfer in the cleavage stage
• Presence of low-quality (<2BB) blastocysts
• >15% loss of viability of the embryo during embryo thawing,
• Patients with congenital uterine malformations,
• Patients in whom Doppler velocimetry cannot be performed optimally

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

ŞAFAK OLGAN

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ŞAFAK OLGAN, MD

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

ARİF ÖZSİPAHİ, MD

Role: STUDY_CHAIR

Akdeniz University

Locations

Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

ŞAFAK OLGAN, MD

Role: CONTACT

safakolgan@gmail.com

00905064068740

ARİF C ÖZSİPAHİ, MD

Role: CONTACT

a.canozsipahi@hotmail.com

005068301073

Facility Contacts

Şafak Olgan, MD

Role: primary

safakolgan@gmail.com

+905064068740

Arif C Özsipahi, MD

Role: backup

a.canozsipahi@hotmail.com

+905068301073

Other Identifiers

49829698

Identifier Type: -

Identifier Source: org_study_id