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

May 7, 2024 updated by: University Hospital, Bordeaux
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bordeaux, France
        • CHU Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
POI
Woman aged 18 years and older, diagnosed with POI following ESHRE 2016 criteria
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
women's satisfaction
Time Frame: Baseline
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient's expectations
Time Frame: Baseline
Patient's expectations regarding POI disclosure
Baseline
gynecological follow-up
Time Frame: Baseline
Rate of patients having regular gynecological follow-up
Baseline
hormone replacement therapy
Time Frame: Baseline
Percentage of patients undergoing hormone replacement therapy (HRT)
Baseline
interrupted HRT
Time Frame: Baseline
Percentage of patients who interrupted HRT for more than one year
Baseline
bone mineral density evaluation
Time Frame: Baseline
Percentage of patients who ever had a bone mineral density evaluation
Baseline
osteoporosis
Time Frame: Baseline
Prevalence of osteoporosis
Baseline
cardiovascular risk factor
Time Frame: Baseline
Prevalence of patients with cardiovascular risk factor(s).
Baseline
side effects when taking HRT
Time Frame: Baseline
Prevalence of patients experiencing side effects when taking HRT
Baseline
residual symptoms of POI
Time Frame: Baseline
Prevalence of patients with residual symptoms of POI despite HRT
Baseline
cervical cancer
Time Frame: Baseline
Percentage of patients who had cervical cancer screening following current guidelines.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2023/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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