The Effect of Baseline Bilateral Uterine Artery Doppler Velocimetry on Obstetric Outcomes in HRT-FET Cycles

NCT05526014 | Unknown

• 1 other identifier: 49849696
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers aim to determine how baseline (pre-conceptional) uterine perfusion characteristics affect implantation rates and obstetric complications in women who underwent high-quality blastocyst transfer.

Conditions

Infertility

Keywords

Uterine artery Doppler velocimetry; Frozen - thawed embryo transfer

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

  24th gestational weeks till delivery

Secondary Outcomes (1)

• Positive β-hCG results

  Nine days after each embryo transfer

Study Arms (3)

non-pregnant

negative b-hCG results 9 days after embryo transfer.

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.

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• 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. All included patients will have bilateral uterine artery Doppler velocimetry on 2-5 days of their menstrual cycle by transvaginal ultrasonography.

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

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• ŞAFAK OLGAN, MD

  Akdeniz University

  PRINCIPAL INVESTIGATOR

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: August 31, 2022
• First Posted: September 2, 2022
• Study Start: May 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 15, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

TU (1)