Thyroid Disorders Complicating PregnancyTSH-MINDNCT07272213
Thyroid-Stimulating Hormone Levels in Pregnancy and Their Association With Depression, Anxiety, and Sexual Function
An observational study of Thyroid Disorders Complicating Pregnancy and Maternal Depression in Pregnancy, Unspecified Trimester, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thyroid Disorders Complicating Pregnancy, Maternal Depression in Pregnancy, Unspecified Trimester, Anxiety Disorder, Unspecified
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 1 Dec 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
SBÜ Gaziosmanpaşa Training and Research Hospital
Istanbul, Gaziosmanpaşa, 33400
havva betül bacak, md, +905333610088, hbbacak90@gmail.com
fatih irice, md, 5055434973, fatihirice@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Disorders Complicating Pregnancy, Maternal Depression in Pregnancy, Unspecified Trimester, Anxiety Disorder, Unspecified, Sexual Dysfunction, Unspecified
- Keywords
- Thyroid disorders complicating pregnancy, Maternal depression in pregnancy, unspecified trimester, Anxiety disorder, unspecified, Sexual dysfunction, unspecified
- Medical subject headings
- Anxiety Disorders, Sexual Dysfunction, Physiological
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Association Between TSH Levels and Psychometric Scale Scores
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.
Measured: At enrollment (single visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Nov 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Disorders Complicating PregnancyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Havva Betül Bacak, Gaziosmanpasa Research and Education Hospital
- Investigators
- havva betül bacak, md, Principal investigator, SBÜ Gaziosmanpaşa Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272213
- Sponsor's protocol ID
- GOPKAD-TSH-DEP-2025
- Acronym
- TSH-MIND
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Thyroid-Stimulating Hormone (TSH) Levels in Pregnancy on Depression, Anxiety, and Sexual Function
- ClinicalTrials.gov ID
- NCT07272213
- Acronym / sponsor ID
- TSH-MIND / GOPKAD-TSH-DEP-2025
- Conditions
- Thyroid Disorders Complicating Pregnancy, Maternal Depression in Pregnancy, Unspecified Trimester, Anxiety Disorder, Unspecified, Sexual Dysfunction, Unspecified
- Keywords
- Thyroid disorders complicating pregnancy, Maternal depression in pregnancy, unspecified trimester, Anxiety disorder, unspecified, Sexual dysfunction, unspecified
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Dec 2025 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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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.
havva betül bacak, md principal investigator
SBÜ Gaziosmanpaşa Training and Research Hospital
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 Thyroid Disorders Complicating Pregnancy and Maternal Depression in Pregnancy, Unspecified Trimester, run by Gaziosmanpasa Research and Education Hospital 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 6 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: looking for participants now, as of the sponsor's last update on 9 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact havva betül bacak, md (+905333610088, hbbacak90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between TSH Levels and Psychometric Scale Scores (time frame: At enrollment (single visit).). 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 9 Dec 2025.