Women's Experience of Premature Ovarian Insufficiency (POI) Diagnosis: Update on Actual Practices and Patient's Follow up

NCT06228547 | Completed

• 1 other identifier: CHUBX 2023/24
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Premature ovarian insufficiency (POI) affects 2,8 to 3,5% of women before the age of 40. Previous foreign studies revealed that only half of POI disclosures occurred during a medical consultation and that the diagnosis was often discussed in less than 5 minutes. As a result, most of patients felt a lack of information, and consequently sought data on the internet. None of these studies were conducted in France. The aim of this study is to analyze current practices related to POI diagnosis and to assess women's satisfaction

Conditions

Premature Ovarian Insufficiency

Keywords

Premature ovarian insufficiency; diagnosis; patient satisfaction; gynecological follow-up; hormone replacement therapy

Outcome Measures

Primary Outcomes (1)

• women's satisfaction

  Women's satisfaction regarding POI disclosure will be evaluated using a standardized questionnaire specifically made for this study. Findings will be presented as a score based on 5 questions assessing patient's experience of POI diagnosis (Healthcare provider adjustments to patient's emotional state, speech clarity, information provided, opportunity to ask questions, relevance of the topics discussed based on the patient's concerns). For each question a score from 1 to 4 will be assigned (Very unsatisfied = 1 ; Unsatisfied = 2 ; Satisfied = 3 ; Very satisfied = 4), resulting in a total score ranging from 5 to 20. Patients scoring from 5 to 8 will be categorized as overall very unsatisfied, 9 to 12 as unsatisfied, 13 to 16 as satisfied, and 17 to 20 as very satisfied

  Baseline

Secondary Outcomes (10)

• Patient's expectations

  Baseline

• gynecological follow-up

  Baseline

• hormone replacement therapy

  Baseline

• interrupted HRT

  Baseline

• bone mineral density evaluation

  Baseline

Study Arms (1)

POI

Woman aged 18 years and older, diagnosed with POI following ESHRE 2016 criteria

Other: Questionnaire

Interventions

Questionnaire OTHER

Standardized questionnaire specifically made for the study. The interview lasts approximately 15 minutes. The form gathers baseline characteristics of the patients such as socio-demographic information, symptoms, lifestyle factors and gynecological history. The questionnaire focuses also on the manner in which the diagnosis was revealed to the patient and their experience of this disclosure. Lastly, the questionnaire includes items issued from French practice guidelines concerning etiological investigations, fertility assessment, osteoporotic and cardiovascular complications, HRT use, and residual symptoms

POI

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Woman aged 18 years and older, diagnosed with POI following ESHRE 2016 criteria

You may qualify if:

• woman aged 18 years and older,
• diagnosed with POI following ESHRE 2016 criteria,
• speaking and reading French language,
• woman's oral consent,
• affiliated or beneficiary of health insurance.

You may not qualify if:

• iatrogenic POI (surgery, radiotherapy, chemotherapy linked),
• chromosomic POI (Turner Syndrome),
• inability for the woman to understand the nature or risks or significance and implications of the study,
• woman under legal protection

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency; Disease; Patient Satisfaction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: July 26, 2023
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)