Evolution of Endometriosis Lesions Followed by Ultrasound and Quality of Life of Patients: Factors That Influence Disease Progression in a Prospective Cohort

NCT07282990 | Not Yet Recruiting DMC

• 1 other identifier: IIBSP-ECE-2024-127
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective cohort study is to determine the factors that influence the progression of endometriosis and the quality of life of patients. The main questions it aims to answer are:

1. 1.Is endometriosis a progressive disease?
2. 2.Is the progression of lesions visualized by ultrasound dependent on the medical treatment received?
3. 3.Does the clinical progression of patients correlate with the progression of lesions visualized on transvaginal ultrasound?
4. 4.Is ultrasound follow-up necessary for patients?
5. 5.Could clinical follow-up alone be safe for selected patients?

Conditions

Endometriosis

Keywords

Endometriosis; Ultrasound; QoL; Progression; Ovarian reserve

Outcome Measures

Primary Outcomes (2)

• Ultrasound-assessed progression of endometriosic lesions at recruitment, 6, 12 and 24 months

  * Ultrasound data used: * Number of lesions (endometriomas and DIE lesions). * Size (assessed in mm; 3 diameters) and characteristics of endometriomas and DIE lesions (described according to IDEA criteria). * Presence or absence of hydronephrosis, adhesions, and hydrosalpinx. * Ultrasound classification according to Enzian Clssification. Outcome variable: PROGRESSION, STABILITY or REGRESSION. This result will be defined as follows: * PROGRESSION: Increase of \> 5mm in the maximum lesion measurement and/or appearance of new lesions and/or increase of 1 point in any item of the Enzian classification. * STABILITY: increase/decrease \<5mm in the maximum lesion measurement and same number of identified lesions and no changes in the score of any item of the Enzian classification. * REGRESSION: decrease \> 5mm in the maximum lesion measurement and/or disappearence of any of the previously described lesions and/or decrease of 1 point in any item of the Enzian classification.

  From enrollment to the end of follow-up at 24 months

• Evolution of clinical presentation at recruitment, 6, 12 and 24 months

  * Symptoms: numeric pain rating scale (zero is equivalent to no pain and 10 indicates the worst possible pain) * Dysmenorrhea * Chronic pelvic pain * Dyschezia * Dyspareunia * Dysuria * Subjective evolution according to patient impressions: Likert scale ("significant improvement" / "moderate improvement" / "stability" / "mild worsening" / "significant worsening")

  From enrollment to the end of follow-up at 24 months

Secondary Outcomes (2)

• Evolution of Ovarian Reserve at recruitment, 6, 12 and 24 months

  From enrollment to the end of follow-up at 24 months

• Evolution of Quality of Life (QoL) at recruitment, 6, 12 and 24 monts

  From enrollment to the end of follow-up at 24 months

Study Arms (1)

Women diagnosed with endometriosis, referred for treatment and/or follow-up to Reference Unit

The study population consists of adult women (18 years or older) with a confirmed diagnosis of endometriosis based on transvaginal ultrasound showing clearly visible and measurable lesions (endometriomas or deep endometriotic lesions suitable for evaluation and follow-up), who are referred for a first consultation at the Endometriosis Reference Unit in Hospital Sant Pau. Patients must not have an expected indication for surgical intervention within the next two years, ensuring stable monitoring of disease progression and treatment effects.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who are referred to Hospital de la Santa Creu i Sant Pau (Barcelona) due to a clinical or sonographic suspicion of endometriosis.

You may qualify if:

• Women with a confirmed diagnosis of endometriosis, based on ultrasound criteria. Diagnosis must be confirmed by transvaginal ultrasound with evidence of visible and measurable endometriotic lesions.
• Patients over 18 years of age. This criterion ensures that participants can provide informed consent and are of reproductive age, when the effects of endometriosis and its treatments are relevant to the study.
• A transvaginal ultrasound performed prior to enrollment showing endometriotic lesions (either endometriomas or deep lesions) with sufficient dimensions and characteristics for evaluation and follow-up.
• Patients who do not have an indication for scheduled surgery within the next two years. This ensures that the effects of treatment and the progression of the disease can be evaluated throughout the study follow-up period.
• Signed informed consent from the patient, indicating that she has understood the purpose of the study, the procedures involved, and the potential risks.

You may not qualify if:

• Patients with an indication for scheduled surgical treatment within the next two years. This includes patients requiring surgery for the removal of endometriotic lesions or to address related complications.
• Patients who are unwilling to undergo follow-up transvaginal ultrasound at scheduled visits (6 months, 1 year, 2 years). Ultrasound is essential for assessing disease progression and the impact of treatment.
• Patients who are unwilling to participate in the study after receiving all the information and providing their informed consent. Voluntary participation is crucial for the ethics of the study.
• Patients with intellectual disabilities or conditions that impair their understanding of the study terms and procedures, which could affect their ability to provide valid informed consent.
• Patients who are pregnant or breastfeeding at the time of enrollment. These conditions can influence the course of endometriosis and the response to treatment, and could complicate disease monitoring.
• Patients with serious concurrent illnesses or medical conditions that may interfere with the assessment of endometriosis, its progression, or the impact of treatment (e.g., severe chronic inflammatory diseases or cancer).
• Patients receiving concurrent treatments not permitted by the study protocol (e.g., experimental treatments for endometriosis or related conditions) that may interfere with the interpretation of the results.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Location

Related Publications (15)

• Vannuccini S, Clemenza S, Rossi M, Petraglia F. Hormonal treatments for endometriosis: The endocrine background. Rev Endocr Metab Disord. 2022 Jun;23(3):333-355. doi: 10.1007/s11154-021-09666-w. Epub 2021 Aug 17.

  PMID: 34405378 BACKGROUND

• Brown J, Crawford TJ, Datta S, Prentice A. Oral contraceptives for pain associated with endometriosis. Cochrane Database Syst Rev. 2018 May 22;5(5):CD001019. doi: 10.1002/14651858.CD001019.pub3.

  PMID: 29786828 BACKGROUND

• Vercellini P, Crosignani P, Somigliana E, Vigano P, Frattaruolo MP, Fedele L. 'Waiting for Godot': a commonsense approach to the medical treatment of endometriosis. Hum Reprod. 2011 Jan;26(1):3-13. doi: 10.1093/humrep/deq302. Epub 2010 Nov 11.

  PMID: 21071490 BACKGROUND

• Becker CM, Bokor A, Heikinheimo O, Horne A, Jansen F, Kiesel L, King K, Kvaskoff M, Nap A, Petersen K, Saridogan E, Tomassetti C, van Hanegem N, Vulliemoz N, Vermeulen N; ESHRE Endometriosis Guideline Group. ESHRE guideline: endometriosis. Hum Reprod Open. 2022 Feb 26;2022(2):hoac009. doi: 10.1093/hropen/hoac009. eCollection 2022.

  PMID: 35350465 BACKGROUND

• National Guideline Alliance (UK). Endometriosis: diagnosis and management. London: National Institute for Health and Care Excellence (NICE); 2017 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK453273/

  PMID: 29787038 BACKGROUND

• Koninckx PR, Fernandes R, Ussia A, Schindler L, Wattiez A, Al-Suwaidi S, Amro B, Al-Maamari B, Hakim Z, Tahlak M. Pathogenesis Based Diagnosis and Treatment of Endometriosis. Front Endocrinol (Lausanne). 2021 Nov 25;12:745548. doi: 10.3389/fendo.2021.745548. eCollection 2021.

  PMID: 34899597 BACKGROUND

• de Ziegler D, Borghese B, Chapron C. Endometriosis and infertility: pathophysiology and management. Lancet. 2010 Aug 28;376(9742):730-8. doi: 10.1016/S0140-6736(10)60490-4.

  PMID: 20801404 BACKGROUND

• Perello MF, Martinez-Zamora MA, Torres X, Munros J, Balasch Cortina J, Carmona F. Endometriotic Pain Is Associated with Adenomyosis but Not with the Compartments Affected by Deep Infiltrating Endometriosis. Gynecol Obstet Invest. 2017;82(3):240-246. doi: 10.1159/000447633. Epub 2016 Oct 7.

  PMID: 27710968 BACKGROUND

• Chamie LP, Ribeiro DMFR, Tiferes DA, Macedo Neto AC, Serafini PC. Atypical Sites of Deeply Infiltrative Endometriosis: Clinical Characteristics and Imaging Findings. Radiographics. 2018 Jan-Feb;38(1):309-328. doi: 10.1148/rg.2018170093.

  PMID: 29320327 BACKGROUND

• Koninckx PR, Ussia A, Adamyan L, Wattiez A, Donnez J. Deep endometriosis: definition, diagnosis, and treatment. Fertil Steril. 2012 Sep;98(3):564-71. doi: 10.1016/j.fertnstert.2012.07.1061.

  PMID: 22938769 BACKGROUND

• Koninckx PR, Ussia A, Adamyan L, Tahlak M, Keckstein J, Wattiez A, Martin DC. The epidemiology of endometriosis is poorly known as the pathophysiology and diagnosis are unclear. Best Pract Res Clin Obstet Gynaecol. 2021 Mar;71:14-26. doi: 10.1016/j.bpobgyn.2020.08.005. Epub 2020 Sep 1.

  PMID: 32978068 BACKGROUND

• 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 BACKGROUND

• De Graaff AA, D'Hooghe TM, Dunselman GA, Dirksen CD, Hummelshoj L; WERF EndoCost Consortium; Simoens S. The significant effect of endometriosis on physical, mental and social wellbeing: results from an international cross-sectional survey. Hum Reprod. 2013 Oct;28(10):2677-85. doi: 10.1093/humrep/det284. Epub 2013 Jul 11.

  PMID: 23847114 BACKGROUND

• Keckstein J, Saridogan E, Ulrich UA, Sillem M, Oppelt P, Schweppe KW, Krentel H, Janschek E, Exacoustos C, Malzoni M, Mueller M, Roman H, Condous G, Forman A, Jansen FW, Bokor A, Simedrea V, Hudelist G. The #Enzian classification: A comprehensive non-invasive and surgical description system for endometriosis. Acta Obstet Gynecol Scand. 2021 Jul;100(7):1165-1175. doi: 10.1111/aogs.14099. Epub 2021 Mar 19.

  PMID: 33483970 BACKGROUND

• Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.

  PMID: 15541453 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood (serum and plasma), urine. Endometriosic tissue if surgical exeresis is performed.

MeSH Terms

Conditions

Endometriosis; Disease Progression

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rocío Luna Guibourg, MD, PhD

CONTACT

+34935537041; rluna@santpau.cat

Aina Delgado-Morell, MD

CONTACT

+34935537041; adelgadom@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 15, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available beginning 6-12 months after publication of the primary results and will remain accessible for at least 5 years.
• Access Criteria: Data will be shared with qualified researchers upon reasonable request sent to study IP. Access will require a data-sharing agreement ensuring appropriate use, data protection, and compliance with ethical standards.

Locations

ES (1)