Comparison of Fetal Thymus Volumes of Pregnant Women With In Vitro Fertilization (IVF) and Spontaneous Pregnant Women.

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05347433
• Other study ID #: 2019/205
• Status: Completed
• Start date: July 9, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: April 2022
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 1, 2021
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

Inclusion Criteria:

• pregnant between 18-24 weeks

• had no complaints

• between the ages of 18-35

• conceived with in vitro fertilization or spontaneously

Exclusion Criteria:

• 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;

• 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

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18-24 week pregnant women
Secondary	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.	during pregnancy and at delivery week