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

Sponsor
Akdeniz University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05661539
Collaborator
(none)
500
1
13.4
37.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transvaginal Ultrasonography

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Baseline and First Trimester Uterine Artery Doppler Velocimetry Parameters on Obstetric Outcomes in HRT-FET Cycles: Prospective Cohort Study
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Jul 15, 2023

Arms and Interventions

Arm 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.

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
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

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, Akdeniz University
  • Study Chair: ARİF ÖZSİPAHİ, MD, Akdeniz University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ŞAFAK OLGAN, Associate Professor, Akdeniz University
ClinicalTrials.gov Identifier:
NCT05661539
Other Study ID Numbers:
  • 49829698
First Posted:
Dec 22, 2022
Last Update Posted:
Feb 1, 2023
Last Verified:
Jan 1, 2023
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 Feb 1, 2023