Infertility, FemaleNCT05661539
Baseline and First Trimester Uterine Artery Doppler Velocimetry to Predict Poor Obstetric Outcomes in IVF
An observational study of Infertility, Female, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Transvaginal Ultrasonography
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 15 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Study population: All patients who have artificial endometrial preparation with high-quality blastocysts between May 2022 and December 2022 will be included.
Who may be able to join
- Exogenous hormone preparation of the endometrial lining
- High embryo quality ((≥2BB) according to Alpha criteria
- Embryo transfer at the blastocyst stage
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Akdeniz University
Antalya, 07700
Şafak Olgan, MD, +905064068740, safakolgan@gmail.com
Arif C Özsipahi, MD, +905068301073, a.canozsipahi@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- Transvaginal Ultrasonography
- Keywords
- Uterine Artery Doppler Velocimetry, Baseline Uterine Artery Doppler Velocimetry, First Trimester Uterine Artery Doppler Velocimetry
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal UltrasonographyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| non-pregnant | negative b-hCG results 9 days after embryo transfer. Receives: Device: Transvaginal Ultrasonography | |
| 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. Receives: Device: Transvaginal Ultrasonography | |
| 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. Receives: Device: Transvaginal Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth Rate
pregnancy beyond 24 weeks of gestational age.
Measured: 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
Measured: 20 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Jun 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion15 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ŞAFAK OLGAN, Akdeniz University
- Investigators
- ŞAFAK OLGAN, MD, Principal investigator, Akdeniz UniversityARİF ÖZSİPAHİ, MD, Study chair, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661539
- Sponsor's protocol ID
- 49829698
- Status last verified
- May 2023
- First submitted
- 14 Dec 2022
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Baseline and First Trimester Uterine Artery Doppler Velocimetry Parameters on Obstetric Outcomes in HRT-FET Cycles: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05661539
- Acronym / sponsor ID
- 49829698
- Conditions
- Infertility, Female
- Keywords
- Uterine Artery Doppler Velocimetry, Baseline Uterine Artery Doppler Velocimetry, First Trimester Uterine Artery Doppler Velocimetry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-pregnant | – | Device: Transvaginal Ultrasonographynegative b-hCG results 9 days after embryo transfer. |
| pregnant with obstetric complications | – | Device: Transvaginal UltrasonographyPatients 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 | – | Device: Transvaginal UltrasonographyPatients 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All patients who have artificial endometrial preparation with high-quality blastocysts between May 2022 and December 2022 will be included.
Key inclusion criteria (3 listed)
- Exogenous hormone preparation of the endometrial lining
- High embryo quality ((≥2BB) according to Alpha criteria
- Embryo transfer at the blastocyst stage
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal UltrasonographyThe 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. | Device | non-pregnant, pregnant with obstetric complications, pregnant without obstetric complications |
Primary outcome
Live Birth Rate
Time frame: 9 months
pregnancy beyond 24 weeks of gestational age.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ŞAFAK OLGAN, MD principal investigator
Akdeniz University
ARİF ÖZSİPAHİ, MD study chair
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ŞAFAK OLGAN, MD (00905064068740, safakolgan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth Rate (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.