Study of the Prevalence of Endometriosis and Adenomyosis

Recruiting

• Conditions: Elective Fertility Preservation
• Interventions: Other: Usual follow-up

• Registration Number: NCT06211569
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-18
• Study Start: 2024-04-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2026-10
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Usual follow-up	Women of childbearing age, consulting for elective fertility preservation

Primary Outcome Measures

Name	Time	Method
Transvaginal pelvic ultrasound	Up to month 6	Search for endometriosis and adenomyosis on transvaginal pelvic ultrasound and characterisation of lesions.

Secondary Outcome Measures

Name	Time	Method
Quality of life assessment (WHO-QOL-BREF)	Inclusion	Between 26 (Poor quality of life) and 130 (good quality of life)
Self-questionnaire	Inclusion	Medical history
Hospital Anxiety and Depression Scale (HADS)	Inclusion	2 scores between 0 (No anxiety or depression) and 21 (lots of anxiety and depression)

Trial Locations

Locations (1)

Gynécologie Obstétrique II et médecine de la reproduction, Hôpital Cochin, Port Royal; 🇫🇷 Paris, Ile De France, France