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

Premature Ovarian Insufficiency Clinical Trial

— EMPOIHER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06228547
• Other study ID #: CHUBX 2023/24
• Status: Completed
• Start date: July 26, 2023
• Est. completion date: April 19, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

POI is defined by the association of 1 clinical and 1 biological criterion: amenorrhea or spaniomenorrhea of > 4 months with onset before 40 year of age, and elevated follicle-stimulating hormone (FSH) > 25 IU/L on 2 assays at > 4 weeks' interval, associated with low estradiol level. This condition affects approximately 2% of young women.

POI can first lead to infertility and various symptoms caused by a lack of estrogens. Thus, patients may experience vaso-motor flushes, genitourinary syndrome, sleep disturbance, humor disorder, decrease libido and dyspareunia. After several years, POI can lead to osteoporosis, increased cardiovascular risk, and dementia. The administration of hormone replacement therapy (HRT) can help prevent these complications. Otherwise, POI may result in psychological repercussions such as anxiety, anger, loss of self-esteem, even depression.

Few studies analyzed POI diagnosis and the way it was perceived by patients. Alzubaidi et al. and subsequently Groff et al. reported that only half of POI notifications occurred during a medical consultation. Moreover, 35% of the consultations lasted less than 5 minutes. Thereby, Singer et al. founds that 68% of women felt inadequately informed. The majority of patients sought additional information on the internet.

No recent study focused on the disclosure of POI diagnosis, and none of the existing studies were conducted in France. The purpose of this study is to analyze the circumstances surrounding POI diagnosis and to evaluate women's experience.

In other ways, in 2016, Bachelot et al. emphasized that after more than 5 years after POI diagnosis, only 61,7% of women were undergoing HRT whereas only 6% had no regular follow-up. Moreover, among the treated patients, 42,6% had already stopped HRT for more than 1 year without any medical recommendation. Therefore, this study aims to examine the association between women satisfaction regarding POI disclosure and their compliance to HRT and medical follow-up

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 19, 2024
• Est. primary completion date: April 19, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Insufficiency
• Primary Ovarian Insufficiency

Intervention

Other:
• Questionnaire
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

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient's expectations	Patient's expectations regarding POI disclosure	Baseline
Secondary	gynecological follow-up	Rate of patients having regular gynecological follow-up	Baseline
Secondary	hormone replacement therapy	Percentage of patients undergoing hormone replacement therapy (HRT)	Baseline
Secondary	interrupted HRT	Percentage of patients who interrupted HRT for more than one year	Baseline
Secondary	bone mineral density evaluation	Percentage of patients who ever had a bone mineral density evaluation	Baseline
Secondary	osteoporosis	Prevalence of osteoporosis	Baseline
Secondary	cardiovascular risk factor	Prevalence of patients with cardiovascular risk factor(s).	Baseline
Secondary	side effects when taking HRT	Prevalence of patients experiencing side effects when taking HRT	Baseline
Secondary	residual symptoms of POI	Prevalence of patients with residual symptoms of POI despite HRT	Baseline
Secondary	cervical cancer	Percentage of patients who had cervical cancer screening following current guidelines.	Baseline