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

Overview

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.

Interventions

• Other Usual follow-up
  Usual follow-up

Primary outcome measures

• Transvaginal pelvic ultrasound [Time frame: Up to month 6]

Secondary outcome measures (4)

• Self-questionnaire [Time frame: Inclusion]
• Self-questionnaire [Time frame: Inclusion]
• Quality of life assessment (WHO-QOL-BREF) [Time frame: Inclusion]
• Hospital Anxiety and Depression Scale (HADS) [Time frame: Inclusion]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

France · 1 center

• Gynécologie Obstétrique II et médecine de la reproduction, Hôpital Cochin, Port Royal — Paris

Publications

• Bird CC, McElin TW, Manalo-Estrella P. The elusive adenomyosis of the uterus--revisited. Am J Obstet Gynecol. 1972 Mar;112(5):583-93. doi: 10.1016/0002-9378(72)90781-8. No abstract available. PMID 5059589
• Bordonne C, Puntonet J, Maitrot-Mantelet L, Bourdon M, Marcellin L, Dion E, Plu-Bureau G, Santulli P, Chapron C. Imaging for evaluation of endometriosis and adenomyosis. Minerva Obstet Gynecol. 2021 Jun;73(3):290-303. doi: 10.23736/S2724-606X.21.04710-9. PMID 34008384
• Bourdon M, Oliveira J, Marcellin L, Santulli P, Bordonne C, Maitrot Mantelet L, Millischer AE, Plu Bureau G, Chapron C. Adenomyosis of the inner and outer myometrium are associated with different clinical profiles. Hum Reprod. 2021 Jan 25;36(2):349-357. doi: 10.1093/humrep/deaa307. PMID 33491057
• Bourdon M, Santulli P, Marcellin L, Maignien C, Maitrot-Mantelet L, Bordonne C, Plu Bureau G, Chapron C. Adenomyosis: An update regarding its diagnosis and clinical features. J Gynecol Obstet Hum Reprod. 2021 Dec;50(10):102228. doi: 10.1016/j.jogoh.2021.102228. Epub 2021 Sep 11. PMID 34520877
• Bulun SE. Endometriosis. N Engl J Med. 2009 Jan 15;360(3):268-79. doi: 10.1056/NEJMra0804690. No abstract available. PMID 19144942
• Chapron C, Marcellin L, Borghese B, Santulli P. Rethinking mechanisms, diagnosis and management of endometriosis. Nat Rev Endocrinol. 2019 Nov;15(11):666-682. doi: 10.1038/s41574-019-0245-z. Epub 2019 Sep 5. PMID 31488888
• Chapron C, Tosti C, Marcellin L, Bourdon M, Lafay-Pillet MC, Millischer AE, Streuli I, Borghese B, Petraglia F, Santulli P. Relationship between the magnetic resonance imaging appearance of adenomyosis and endometriosis phenotypes. Hum Reprod. 2017 Jul 1;32(7):1393-1401. doi: 10.1093/humrep/dex088. PMID 28510724
• Chapron C, Vannuccini S, Santulli P, Abrao MS, Carmona F, Fraser IS, Gordts S, Guo SW, Just PA, Noel JC, Pistofidis G, Van den Bosch T, Petraglia F. Diagnosing adenomyosis: an integrated clinical and imaging approach. Hum Reprod Update. 2020 Apr 15;26(3):392-411. doi: 10.1093/humupd/dmz049. PMID 32097456

Identifiers

NCT: NCT06211569 · APHP231461 · 2023-A01474-41

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗