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

University Hospital of Bordeaux

Status: Completed

Conditions: Premature Ovarian Insufficiency

Treatments: Other: Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT06228547

CHUBX 2023/24

Details and patient eligibility

About

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

Full 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

Enrollment: 101 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

101 participants in 1 patient group

POI

Description:

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

Treatment:

Other: Questionnaire