Clinical trial NCT06211569: Study of the Prevalence of Endometriosis and Adenomyosis
Official title: Study of the Prevalence of Endometriosis and Adenomyosis in Women of Childbearing Age Consulting for Non-medical Oocyte Self-preservation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Elective Fertility Preservation
Keywords: Endometriosis
Adenomyosis
Prevalence
Elective fertility preservation
Transvaginal pelvic ultrasound
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 400
Sex: FEMALE
Minimum age (years): 29
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women of childbearing age, not pregnant, consulting for non-medical oocyte self-preservation

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.

Eligibility criteria: 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

Primary outcomes:
measure: Transvaginal pelvic ultrasound
timeFrame: Up to month 6
Secondary outcomes:
measure: Self-questionnaire
timeFrame: Inclusion
measure: Self-questionnaire
timeFrame: Inclusion
measure: Quality of life assessment (WHO-QOL-BREF)
timeFrame: Inclusion
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Gynécologie Obstétrique II et médecine de la reproduction, Hôpital Cochin, Port Royal
state: Ile De France
Study officials:
References:
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