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

NCT05661539 | Unknown

• 1 other identifier: 49829698
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Keywords

Uterine Artery Doppler Velocimetry; Baseline Uterine Artery Doppler Velocimetry; First Trimester Uterine Artery Doppler Velocimetry

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

Study Arms (3)

non-pregnant

negative b-hCG results 9 days after embryo transfer.

Device: Transvaginal Ultrasonography

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.

Device: Transvaginal Ultrasonography

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.

Device: Transvaginal Ultrasonography

Interventions

Transvaginal Ultrasonography 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.

non-pregnant; pregnant with obstetric complications; pregnant without obstetric complications

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All patients who have artificial endometrial preparation with high-quality blastocysts between May 2022 and December 2022 will be included.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, 07700, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• ŞAFAK OLGAN, MD

  Akdeniz University

  PRINCIPAL INVESTIGATOR

• ARİF ÖZSİPAHİ, MD

  Akdeniz University

  STUDY CHAIR

Central Study Contacts

ŞAFAK OLGAN, MD

CONTACT

00905064068740; safakolgan@gmail.com

ARİF C ÖZSİPAHİ, MD

CONTACT

005068301073; a.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: December 14, 2022
• First Posted: December 22, 2022
• Study Start: June 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: April 15, 2024
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

TU (1)