Clinical trial NCT06228547: Women's Experience of Premature Ovarian Insufficiency (POI) Diagnosis: Update on Actual Practices and Patient's Follow up
Official title: Women's Experience of Premature Ovarian Insufficiency (POI) Diagnosis: Update on Actual Practices and Patient's Follow up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Ovarian Insufficiency
Keywords: Premature ovarian insufficiency
diagnosis
patient satisfaction
gynecological follow-up
hormone replacement therapy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman aged 18 years and older, diagnosed with POI following ESHRE 2016 criteria

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: women's satisfaction
timeFrame: Baseline
Secondary outcomes:
measure: Patient's expectations
timeFrame: Baseline
measure: gynecological follow-up
timeFrame: Baseline
measure: hormone replacement therapy
timeFrame: Baseline
measure: interrupted HRT
timeFrame: Baseline
measure: bone mineral density evaluation
timeFrame: Baseline
measure: osteoporosis
timeFrame: Baseline
measure: cardiovascular risk factor
timeFrame: Baseline
measure: side effects when taking HRT
timeFrame: Baseline
measure: residual symptoms of POI
timeFrame: Baseline
measure: cervical cancer
timeFrame: Baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References: