NCT07295093

Brief Summary

Menopause is defined as the permanent cessation of menstrual cycles due to ovarian follicle depletion, typically occurring after age 50, and is associated with decreased estrogen levels. Primary ovarian insufficiency (POI) involves early ovarian dysfunction before age 40, with infertility as a key concern. Both menopause and POI may contribute to psychological symptoms, including anxiety and depression, influenced by sociodemographic and health factors. While literature reports anxiety in middle-aged women, data on its association with menopausal timing are limited. This study aims to compare women with POI and those undergoing natural menopause after age 40, assessing the relationship between age at menopause, anxiety, and depression, as well as the impact of fertility expectations on psychological well-being in POI patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

December 4, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

MenopausePrimary Ovarian Insufficiency (Poi)Anxietydepression

Outcome Measures

Primary Outcomes (2)

  • Beck Anxıety Inventory (BAI), Anxiety level

    Anxiety severity measured by the Beck Anxiety Inventory (BAI) during routine clinic visit.

    Baseline (single assessment at enrollment during routine clinic visit).

  • State-Trait Anxiety Scale (STAI) 1-2, Anxiety level

    Anxiety severity measured by the State-Trait Anxiety Inventory (STAI) forms 1 and 2 during routine clinic visit.

    Baseline (single assessment at enrollment during routine clinic visit).

Study Arms (2)

Menopause group

Patients over 40 years of age who have undergone menopause and who visited our hospital's obstetrics and gynecology outpatient clinic for routine check-ups, without any additional diseases or complaints.

Other: Beck Anxıety Inventory (BAI)Other: State-Trait Anxiety Scale (STAI) 1-2

Primary ovarian insufficiency (POI) group

Patients who experienced menopause before the age of 40 and who visited our hospital's obstetrics and gynecology outpatient clinic for routine check-ups, without any additional diseases or complaints.

Other: Beck Anxıety Inventory (BAI)Other: State-Trait Anxiety Scale (STAI) 1-2

Interventions

Beck Anxıety Inventory (BAI) Description: The scale will be self-administered and completed by the patient during the routine outpatient clinic visit.

Also known as: State-Trait Anxiety Scale (STAI) 1-2
Menopause groupPrimary ovarian insufficiency (POI) group

State-Trait Anxiety Scale (STAI) 1-2 Description: The scale will be self-administered and completed by the patient during the routine outpatient clinic visit.

Menopause groupPrimary ovarian insufficiency (POI) group

Eligibility Criteria

Age24 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligible: Female participants only. This study specifically includes women who have undergone menopause, as well as women diagnosed with primary ovarian insufficiency (POI). Not Eligible: Male participants and individuals who do not identify as female.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 136 participants were included in the study, of whom 83 were in the menopause group and 53 in the primary ovarian insufficiency group.

You may qualify if:

  • Healthy women over 24 years of age who visited our hospital for routine outpatient check-ups, had been diagnosed with menopause, and had no history of psychiatric disorders before menopause.

You may not qualify if:

  • Cardiovascular diseases including hypertension
  • Type 1 or type 2 diabetes mellitus
  • Morbid obesity
  • Primary adrenal insufficiency
  • Uterine fibroids
  • Thyroid dysfunctions including Hashimoto thyroiditis and Grave's disease
  • Hepatic dysfunctions
  • Renal insufficiency
  • Genetic disorders in chromosome constitution or karyotype analysis including monosomy X, trisomy X and gene mutations as BMP15, FMR I, POFIB, and GDF9
  • Neurologic diseases
  • Psychiatric disorders
  • Autoimmune diseases or syndromes including Addison's disease, autoimmune syndromes, scleroderma, Sjogren's syndrome, myasthenia gravis, inflammatory bowel diseases, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and familial Mediterranean fever
  • History of any malignancy
  • History of exposure to chemotherapeutic agents or radiotherapy
  • Individuals with a history of chronic or regular medication use that could cause anxiety or depression symptoms
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Not Valid, 06100, Turkey (Türkiye)

Location

Related Publications (5)

  • Bromberger JT, Meyer PM, Kravitz HM, Sommer B, Cordal A, Powell L, Ganz PA, Sutton-Tyrrell K. Psychologic distress and natural menopause: a multiethnic community study. Am J Public Health. 2001 Sep;91(9):1435-42. doi: 10.2105/ajph.91.9.1435.

    PMID: 11527777BACKGROUND
  • Zollner YF, Acquadro C, Schaefer M. Literature review of instruments to assess health-related quality of life during and after menopause. Qual Life Res. 2005 Mar;14(2):309-27. doi: 10.1007/s11136-004-0688-z.

    PMID: 15892422BACKGROUND
  • Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.

    PMID: 22588767BACKGROUND
  • Bryant C, Judd FK, Hickey M. Anxiety during the menopausal transition: a systematic review. J Affect Disord. 2012 Jul;139(2):141-8. doi: 10.1016/j.jad.2011.06.055. Epub 2011 Jul 23.

    PMID: 21783260BACKGROUND
  • Grigolon RB, Ceolin G, Deng Y, Bambokian A, Koning E, Fabe J, Lima M, Gerchman F, Soares CN, Brietzke E, Gomes FA. Effects of nutritional interventions on the severity of depressive and anxiety symptoms of women in the menopausal transition and menopause: a systematic review, meta-analysis, and meta-regression. Menopause. 2023 Jan 1;30(1):95-107. doi: 10.1097/GME.0000000000002098. Epub 2022 Nov 7.

    PMID: 36576445BACKGROUND

MeSH Terms

Conditions

Primary Ovarian InsufficiencyAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Merve Didem Eşkin Tanrıverdi

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 19, 2025

Study Start

December 15, 2024

Primary Completion

August 5, 2025

Study Completion

September 15, 2025

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

IPD are available which may be shared in necessary conditions.

Locations