Study of the Prevalence of Endometriosis and Adenomyosis (PrevADEOSE)

February 5, 2024 updated by: Assistance Publique - Hôpitaux de Paris

Study of the Prevalence of Endometriosis and Adenomyosis in Women of Childbearing Age Consulting for Non-medical Oocyte Self-preservation

Our study aims to assess the prevalence of adenomyosis and endometriosis in patients consulting for elective fertility preservation through the diagnosis of these pathologies by transvaginal pelvic ultrasound. Imaging data will be compared with clinical data (patient characteristics, clinical symptoms) as well as the assessment of anxiety, depression, and quality of life collected from the women.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Adenomyosis and endometriosis are two heterogeneous benign gynecological pathologies, in terms of the presence of diverse phenotypes and their symptomatic presentation: While some women are entirely asymptomatic, others experience pelvic pain, infertility, or abnormal uterine bleeding.

Assessing the prevalence of these two pathologies is challenging: On the one hand, a significant number of women are asymptomatic and not considered in the calculation; on the other hand, endometriosis and adenomyosis are often underdiagnosed, leading to delayed diagnosis.

Endometriosis and adenomyosis are frequently associated. Improving knowledge about the epidemiology of endometriosis and adenomyosis is crucial as both are major causes of clinical symptoms that adversely affect the quality of life in numerous women. This is a significant issue for women's health due to the associated suffering, numerous surgical interventions, healthcare expenses, and the suggested link with pathologies that may affect other organs. Understanding the disease could lead to improved treatment and the development of preventive strategies.

Therefore, it is urgent to determine the frequency of endometriosis and adenomyosis, as well as the correlation between women's characteristics, especially their clinical symptoms, and different phenotypes. In order to assess the prevalence of adenomyosis and endometriosis in a population of women of reproductive age, the investigators intend to conduct this single-center study focusing on patients consulting for non-medical fertility preservation.

Study Type

Observational

Enrollment (Estimated)

400

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 Backup

Study Locations

  • France
    • Ile De France
      • Paris, Ile De France, France, 75014
        • Gynécologie Obstétrique II et médecine de la reproduction, Hôpital Cochin, Port Royal
        • Contact:
        • Sub-Investigator:
          • Pietro SANTULLI
        • Principal Investigator:
          • Mathilde BOURDON

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women of childbearing age, not pregnant, consulting for non-medical oocyte self-preservation

Description

Inclusion Criteria:

  • Woman aged between 29 and 37
  • Consultant for non-medical fertility preservation in the Reproductive Medicine Unit Port Royal, Cochin
  • Informed and not opposed to this research
  • Affiliated to a social security scheme

Exclusion Criteria:

  • Pregnant women
  • Refusing to take part in the study
  • Under court protection, curatorship or guardianship
  • Women with a known malformation of the genital tract

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
Intervention / Treatment
Patients
Women of childbearing age, consulting for elective fertility preservation
Other: Usual follow-up
Usual follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transvaginal pelvic ultrasound
Time Frame: Up to month 6
Search for endometriosis and adenomyosis on transvaginal pelvic ultrasound and characterisation of lesions.
Up to month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-questionnaire
Time Frame: Inclusion
Socio-demographic data
Inclusion
Self-questionnaire
Time Frame: Inclusion
Medical history
Inclusion
Quality of life assessment (WHO-QOL-BREF)
Time Frame: Inclusion
Between 26 (Poor quality of life) and 130 (good quality of life)
Inclusion
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Inclusion
2 scores between 0 (No anxiety or depression) and 21 (lots of anxiety and depression)
Inclusion

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

February 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP231461
  • 2023-A01474-41 (Other Identifier: France : Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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