HealthyNCT05347433
Comparison of Fetal Thymus Volumes of Pregnant Women With In Vitro Fertilization (IVF) and Spontaneous Pregnant Women.
An observational study of Healthy, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study was to compare the fetal thymus volumes of 18-24-week pregnant women with In Vitro Fertilization (IVF) and spontaneous pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jul 2019to 1 Aug 2021
- How long will I take part?
- 6 Months
- 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 34 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study group consisted of normal pregnant women who applied to the pregnancy clinic for routine pregnancy follow-ups
Who may be able to join
- pregnant between 18-24 weeks
- had no complaints
- between the ages of 18-35
- conceived with in vitro fertilization or spontaneously
Who cannot join
- history of endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease, and congenital adrenal hyperplasia), systemic diseases (e.g. asthma), collagen disorder, hypercholesterolemia, sickle cell anemia, or neoplasm,
- those who had a history of coronary artery disease, angina, or myocardial infarction, or a history of hypertension, coronary arteritis, and electrocardiographic changes that suggest any known history of vascular, infectious, or inflammatory disease, maternal autoimmune disease,
- use of any drugs other than those used for IVF (e.g. insulin sensitizing drugs, oral contraceptives, antiandrogens, statins, aspirin, and corticosteroids) in the 3 months before the pregnancy,
- multiple pregnancy,
- present cigarette and alcohol use,
- abnormal renal, hepatic, and thyroid function test results;
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- refusing to participate in the study,
- abnormal fetal findings (fetal anomaly, increased nape transparency, first-second trimester screening test disorder),
- cases who did not meet the criteria for pregnancy after the first tube treatment (ICSI-ET) because of normoresponder, unexplained infertility, or male factor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 18-24 Week Pregnant Women With in Vitro Fertilization (IVF) and Pregnant Women With Spontaneous Pregnancy in the Same Week in Terms of Fetal Thymus Volume
The purpose of the study was to compare the fetal thymus volumes of 18-24-week pregnant women with In Vitro Fertilization (IVF) and spontaneous pregnant women.
- Conditions
- Healthy
- Keywords
- Fetal thymus volume, In vitro fertilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tube baby pregnancy group | 18-24-week pregnant women with in vitro fertilization | |
| Spontaneous pregnancy group | 18-24-week pregnant women with spontaneous |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of fetal thymus volume
The thymus is located at the superior part of the fetal rib cage. When the transverse section, which includes three vessel images (Superior Vena Cava, Aorta, Pulmonary Artery) is taken, fetal sternum is observed between the three-vessel view and fetal lungs. It is found as a hypoechoic two-lobe structure in the anterior mediastinum compared to other tissues. The fetal thymus dimensions were evaluated by one single person by using the VOLUSON E-10 ultrasonography, which can make VOCAL measurements with 2D and 3D VOCAL Program in 3-vessel trachea sections.
Measured: 18-24 week pregnant women
Secondary outcomes (1)
frequency of pregnancy complications
The cases were followed up during pregnancy and at delivery week, and frequency of preeclampsia, non-reliable fetal status, Intrauterine growth restriction and neonatal intensive care requirement wererecorded.
Measured: during pregnancy and at delivery week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start9 Jul 2019
- Primary completion31 Jul 2020
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurgül Selin KAYA, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347433
- Sponsor's protocol ID
- 2019/205
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 18-24 Week Pregnant Women With in Vitro Fertilization (IVF) and Pregnant Women With Spontaneous Pregnancy in the Same Week in Terms of Fetal Thymus Volume
- ClinicalTrials.gov ID
- NCT05347433
- Acronym / sponsor ID
- 2019/205
- Conditions
- Healthy
- Keywords
- Fetal thymus volume, In vitro fertilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 26 Apr 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 purpose of the study was to compare the fetal thymus volumes of 18-24-week pregnant women with In Vitro Fertilization (IVF) and spontaneous pregnant women.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tube baby pregnancy group | – | –18-24-week pregnant women with in vitro fertilization |
| Spontaneous pregnancy group | – | –18-24-week pregnant women with spontaneous |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study group consisted of normal pregnant women who applied to the pregnancy clinic for routine pregnancy follow-ups
Key inclusion criteria (4 listed)
- pregnant between 18-24 weeks
- had no complaints
- between the ages of 18-35
- conceived with in vitro fertilization or spontaneously
Key exclusion criteria (9 listed)
- history of endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease, and congenital adrenal hyperplasia), systemic diseases (e.g. asthma), collagen disorder, hypercholesterolemia, sickle cell anemia, or neoplasm,
- those who had a history of coronary artery disease, angina, or myocardial infarction, or a history of hypertension, coronary arteritis, and electrocardiographic changes that suggest any known history of vascular, infectious, or inflammatory disease, maternal autoimmune disease,
- use of any drugs other than those used for IVF (e.g. insulin sensitizing drugs, oral contraceptives, antiandrogens, statins, aspirin, and corticosteroids) in the 3 months before the pregnancy,
- multiple pregnancy,
- present cigarette and alcohol use,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measurement of fetal thymus volume
Time frame: 18-24 week pregnant women
The thymus is located at the superior part of the fetal rib cage. When the transverse section, which includes three vessel images (Superior Vena Cava, Aorta, Pulmonary Artery) is taken, fetal sternum is observed between the three-vessel view and fetal lungs. It is found as a hypoechoic two-lobe structure in the anterior mediastinum compared to other tissues. The fetal thymus dimensions were evaluated by one single person by using the VOLUSON E-10 ultrasonography, which can make VOCAL measurements with 2D and 3D VOCAL Program in 3-vessel trachea sections.
1 secondary outcome
frequency of pregnancy complications
Time frame: during pregnancy and at delivery week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy, run by Karadeniz Technical 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 26 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of fetal thymus volume (time frame: 18-24 week pregnant women). 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 26 Apr 2022.