Thyroid-Stimulating Hormone Levels in Pregnancy and Their Association With Depression, Anxiety, and Sexual Function (TSH-MIND)

November 26, 2025 updated by: Havva Betül Bacak, Gaziosmanpasa Research and Education Hospital

Evaluation of the Effects of Thyroid-Stimulating Hormone (TSH) Levels in Pregnancy on Depression, Anxiety, and Sexual Function

This prospective, single-center, observational cross-sectional study aims to evaluate the relationship between thyroid-stimulating hormone (TSH) levels and psychological as well as sexual health outcomes during pregnancy. Pregnant individuals will undergo psychometric assessment using the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), the Arizona Sexual Experience Scale (ASEX), and the YKK-13 Quality of Life Scale. The study will investigate whether maternal TSH levels are associated with depression, anxiety, sexual function, and overall quality of life scores.

Eligible participants will be pregnant women aged 18-45 years with a singleton pregnancy of at least 6 weeks, who are literate and have provided informed consent. Individuals with a prior psychiatric history, multiple gestation, or existing systemic or endocrine diseases will be excluded. The primary endpoint of the study is to determine the association between TSH levels and psychometric scale scores during pregnancy.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Pregnancy is a period characterized by significant physiological, hormonal, and psychological changes that may influence maternal well-being. Thyroid-stimulating hormone (TSH) plays a central role in endocrine regulation during pregnancy, and alterations in thyroid function have been associated with mood disorders, anxiety symptoms, and changes in sexual function. Despite emerging evidence suggesting a link between thyroid status and maternal mental health, the relationship between TSH levels and psychological outcomes during pregnancy remains insufficiently explored.

This prospective, single-center, observational cross-sectional study aims to systematically evaluate the association between maternal TSH levels and psychometric parameters, including depression, anxiety, sexual function, and quality of life. Participants will be assessed using validated instruments: the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), the Arizona Sexual Experience Scale (ASEX), and the YKK-13 Quality of Life Scale. Blood samples will be collected to measure serum TSH levels, and questionnaire scores will be obtained during routine prenatal follow-up visits.

The study population will consist of pregnant women aged 18-45 years with a singleton pregnancy of at least six weeks' gestation. Individuals with a history of psychiatric disorders, multiple gestations, or systemic/endocrine diseases will be excluded to minimize confounding factors. Data will be analyzed to determine whether variations in TSH levels are correlated with psychometric outcomes, and to better understand the potential role of thyroid function in maternal psychological and sexual health.

The ultimate goal of this research is to provide clinical insight into how thyroid function may influence mental and sexual well-being during pregnancy, thereby supporting early identification and management of at-risk pregnant individuals.

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Gaziosmanpaşa
      • Istanbul, Gaziosmanpaşa, Turkey (Türkiye), 33400
        • Recruiting
        • SBÜ Gaziosmanpaşa Training and Research Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of pregnant women aged 18-45 years who are receiving routine prenatal care at SBÜ Gaziosmanpaşa Training and Research Hospital. Eligible participants will have a singleton pregnancy of at least 6 weeks' gestation, a recent TSH measurement obtained within the past 4 weeks, and sufficient cognitive ability to complete standardized psychometric assessments. Individuals with multiple gestation, diagnosed psychiatric disorders, thyroid disease requiring treatment, major systemic illness, or obstetric complications will be excluded to ensure a homogeneous cohort.

Description

Inclusion Criteria:

Pregnant women aged 18-45 years

Singleton pregnancy

Gestational age ≥ 6 weeks

Literacy and ability to provide informed consent

Availability of a TSH result obtained within the past 4 weeks

Cognitive ability sufficient to complete the psychometric questionnaires (Beck Depression Inventory, Beck Anxiety Inventory, ASEX, and YKK-13 Quality of Life Scale)

Exclusion Criteria:

Multiple pregnancy

Previously diagnosed psychiatric disorder or active use of antidepressant/ anxiolytic medication

Current treatment for thyroid disease

History of thyroid surgery

Major systemic illness or significant obstetric complications

Age under 18 years or inability to provide informed consent

Inability to complete the questionnaires adequately (missing or invalid data)

Rationale:

Multiple pregnancies are excluded because they differ significantly from singleton pregnancies in terms of hormonal profile, obstetric risks, and psychological stress levels. This exclusion aims to ensure a homogeneous study population.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
TSH ≤2.5 Group
Participants in this cohort have serum TSH levels ≤2.5 mIU/L. No intervention will be administered. Participants will undergo psychometric evaluation using the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), the Arizona Sexual Experience Scale (ASEX), and the YKK-13 Quality of Life Scale. The purpose is to assess psychological and sexual function outcomes in relation to normal-range TSH levels.
TSH >2.5 Group
Participants in this cohort have serum TSH levels >2.5 mIU/L. No intervention will be administered. Participants will complete the same psychometric assessments (BDI, BAI, ASEX, YKK-13). This group will allow comparison of psychological, anxiety-related, sexual function, and quality-of-life outcomes associated with elevated TSH levels during pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association Between TSH Levels and Psychometric Scale Scores
Time Frame: At enrollment (single visit).
To evaluate the relationship between maternal TSH levels (≤2.5 mIU/L vs. >2.5 mIU/L) and psychological outcomes measured by the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), the Arizona Sexual Experience Scale (ASEX), and the YKK-13 Quality of Life Scale. The primary endpoint is the difference in psychometric scores between the two TSH groups and the correlation between serum TSH levels and these scores.
At enrollment (single visit).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziosmanpasa Research and Education Hospital

Investigators

  • Principal Investigator: havva betül bacak, md, SBÜ Gaziosmanpaşa Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOPKAD-TSH-DEP-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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