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

NCT ID: NCT05526014

Last Updated: 2023-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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non-pregnant

negative b-hCG results 9 days after embryo transfer.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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ŞAFAK OLGAN

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ŞAFAK OLGAN, MD

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Locations

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Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ŞAFAK OLGAN, MD

Role: CONTACT

00905064068740

ARİF C ÖZSİPAHİ, MD

Role: CONTACT

005068301073

Facility Contacts

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Şafak Olgan, MD

Role: primary

+905064068740

Arif C Özsipahi, MD

Role: backup

+905068301073

Other Identifiers

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49849696

Identifier Type: -

Identifier Source: org_study_id

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