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

Infertility Clinical Trial

Official title:

The Effect of Baseline Bilateral Uterine Artery Doppler Velocimetry on Obstetric Outcomes in Hormonally Prepared Vitrified-Warmed Blastocyst Transfer Cycles: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05526014
• Other study ID #: 49849696
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: May 2023
• Source: Akdeniz University
• Contact: SAFAK OLGAN, MD
• Phone: 00905064068740
• Email: safakolgan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

In hormonally prepared frozen embryo transfer cycles, basal bilateral uterine artery Doppler velocimetry will be performed before treatment (pre-conceptional) in each patient. Only patients who have high-quality blastocyst stage embryos will be included in the study. Since the implantation potential of the specified embryos is high, possible embryo-induced implantation failure would be minimized.

Bilateral uterine artery Doppler velocimetry will be performed during the basal ultrasonography (on the 2-5th day of menstruation). Any uterine artery notch, absent diastolic or reverse flow also will be recorded. 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.

A pregnancy test will be performed 9 days after embryo transfer. Pregnant patients will be called for ultrasonography control 3 weeks later to determine fetal heartbeat. Additionally, the patients will be followed till labor and any obstetric complications will be recorded.

Uterine artery Doppler ultrasonography findings in patients with and without pregnancy will be compared. Additionally, in the group in which pregnancy was achieved, obstetric results including birth weight, small-large for gestational age, presence of hypertension, and preterm labor will be correlated with baseline (pre-conceptional) uterine artery Doppler parameters.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 15, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live Birth Rate	pregnancy beyond 24 weeks of gestational age.	9 months
Primary	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	Positive ß-hCG results	Positive ß-hCG results nine days after embryo transfer.	Nine days after each embryo transfer