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

May 20, 2023 updated by: ŞAFAK OLGAN, Akdeniz University

The Effect of Baseline and First Trimester Uterine Artery Doppler Velocimetry Parameters on Obstetric Outcomes in HRT-FET Cycles: Prospective Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Antalya, Turkey, 07700
        • Recruiting
        • Akdeniz University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Şafak Olgan, MD
        • Sub-Investigator:
          • Arif C Özsipahi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non-pregnant
negative b-hCG results 9 days after embryo transfer.
Device: 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.
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
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live Birth Rate
Time Frame: 9 months
pregnancy beyond 24 weeks of gestational age.
9 months
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
20 weeks after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Investigators

  • Principal Investigator: ŞAFAK OLGAN, MD, Akdeniz University
  • Study Chair: ARİF ÖZSİPAHİ, MD, Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

April 15, 2024

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 22, 2022

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 20, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49829698

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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