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Completed

NCT Number: NCT05347433

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

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.

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Key information

Conditions

Age range

18 year–34 year

Sex eligibility

Female

Study type

Observational

Primary location

Karadeniz Technical University

Trabzon, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. frequency of pregnancy complications

    Time frame: during pregnancy and at delivery week

    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.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 26, 2022
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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