Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT06211569
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2024-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Prevalence of Endometriosis and Adenomyosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D062788', 'term': 'Adenomyosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transvaginal pelvic ultrasound', 'timeFrame': 'Up to month 6', 'description': 'Search for endometriosis and adenomyosis on transvaginal pelvic ultrasound and characterisation of lesions.'}], 'secondaryOutcomes': [{'measure': 'Self-questionnaire', 'timeFrame': 'Inclusion', 'description': 'Socio-demographic data'}, {'measure': 'Self-questionnaire', 'timeFrame': 'Inclusion', 'description': 'Medical history'}, {'measure': 'Quality of life assessment (WHO-QOL-BREF)', 'timeFrame': 'Inclusion', 'description': 'Between 26 (Poor quality of life) and 130 (good quality of life)'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Inclusion', 'description': '2 scores between 0 (No anxiety or depression) and 21 (lots of anxiety and depression)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometriosis', 'Adenomyosis', 'Prevalence', 'Elective fertility preservation', 'Transvaginal pelvic ultrasound'], 'conditions': ['Elective Fertility Preservation']}, 'referencesModule': {'references': [{'pmid': '5059589', 'type': 'BACKGROUND', 'citation': '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': '34008384', 'type': 'BACKGROUND', 'citation': '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': '33491057', 'type': 'BACKGROUND', 'citation': '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': '34520877', 'type': 'BACKGROUND', 'citation': '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': '19144942', 'type': 'BACKGROUND', 'citation': 'Bulun SE. Endometriosis. N Engl J Med. 2009 Jan 15;360(3):268-79. doi: 10.1056/NEJMra0804690. No abstract available.'}, {'pmid': '31488888', 'type': 'BACKGROUND', 'citation': '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': '28510724', 'type': 'BACKGROUND', 'citation': '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': '32097456', 'type': 'BACKGROUND', 'citation': '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': '25201608', 'type': 'BACKGROUND', 'citation': 'Di Donato N, Montanari G, Benfenati A, Leonardi D, Bertoldo V, Monti G, Raimondo D, Seracchioli R. Prevalence of adenomyosis in women undergoing surgery for endometriosis. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:289-93. doi: 10.1016/j.ejogrb.2014.08.016. Epub 2014 Aug 15.'}, {'pmid': '5624198', 'type': 'BACKGROUND', 'citation': 'Schwartz JC. Incidence of listeriosis in Pennsylvania livestock. J Am Vet Med Assoc. 1967 Dec 1;151(11):1435-7. No abstract available.'}, {'pmid': '16172113', 'type': 'BACKGROUND', 'citation': 'Fauconnier A, Chapron C. Endometriosis and pelvic pain: epidemiological evidence of the relationship and implications. Hum Reprod Update. 2005 Nov-Dec;11(6):595-606. doi: 10.1093/humupd/dmi029. Epub 2005 Sep 19.'}, {'pmid': '15541453', 'type': 'BACKGROUND', 'citation': 'Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.'}, {'pmid': '9328356', 'type': 'BACKGROUND', 'citation': 'Endo T, Kaneshige M, Nakazato M, Ohmori M, Harii N, Onaya T. Thyroid transcription factor-1 activates the promoter activity of rat thyroid Na+/I- symporter gene. Mol Endocrinol. 1997 Oct;11(11):1747-55. doi: 10.1210/mend.11.11.0012.'}, {'pmid': '22990516', 'type': 'BACKGROUND', 'citation': 'Hudelist G, Fritzer N, Thomas A, Niehues C, Oppelt P, Haas D, Tammaa A, Salzer H. Diagnostic delay for endometriosis in Austria and Germany: causes and possible consequences. Hum Reprod. 2012 Dec;27(12):3412-6. doi: 10.1093/humrep/des316. Epub 2012 Sep 17.'}, {'pmid': '31160242', 'type': 'BACKGROUND', 'citation': 'Khan KN, Fujishita A, Koshiba A, Kuroboshi H, Mori T, Ogi H, Itoh K, Nakashima M, Kitawaki J. Biological differences between intrinsic and extrinsic adenomyosis with coexisting deep infiltrating endometriosis. Reprod Biomed Online. 2019 Aug;39(2):343-353. doi: 10.1016/j.rbmo.2019.03.210. Epub 2019 Mar 27.'}, {'pmid': '15919780', 'type': 'BACKGROUND', 'citation': 'Kunz G, Beil D, Huppert P, Noe M, Kissler S, Leyendecker G. Adenomyosis in endometriosis--prevalence and impact on fertility. Evidence from magnetic resonance imaging. Hum Reprod. 2005 Aug;20(8):2309-16. doi: 10.1093/humrep/dei021. Epub 2005 May 26.'}, {'pmid': '25241270', 'type': 'BACKGROUND', 'citation': 'Leyendecker G, Bilgicyildirim A, Inacker M, Stalf T, Huppert P, Mall G, Bottcher B, Wildt L. Adenomyosis and endometriosis. Re-visiting their association and further insights into the mechanisms of auto-traumatisation. An MRI study. Arch Gynecol Obstet. 2015 Apr;291(4):917-32. doi: 10.1007/s00404-014-3437-8. Epub 2014 Sep 21.'}, {'pmid': '35345070', 'type': 'BACKGROUND', 'citation': 'Moradi Y, Shams-Beyranvand M, Khateri S, Gharahjeh S, Tehrani S, Varse F, Tiyuri A, Najmi Z. A systematic review on the prevalence of endometriosis in women. Indian J Med Res. 2021 Mar;154(3):446-454. doi: 10.4103/ijmr.IJMR_817_18.'}, {'pmid': '27101396', 'type': 'BACKGROUND', 'citation': 'Morassutto C, Monasta L, Ricci G, Barbone F, Ronfani L. Incidence and Estimated Prevalence of Endometriosis and Adenomyosis in Northeast Italy: A Data Linkage Study. PLoS One. 2016 Apr 21;11(4):e0154227. doi: 10.1371/journal.pone.0154227. eCollection 2016.'}, {'pmid': '23001775', 'type': 'BACKGROUND', 'citation': 'Naftalin J, Hoo W, Pateman K, Mavrelos D, Holland T, Jurkovic D. How common is adenomyosis? A prospective study of prevalence using transvaginal ultrasound in a gynaecology clinic. Hum Reprod. 2012 Dec;27(12):3432-9. doi: 10.1093/humrep/des332. Epub 2012 Sep 20.'}, {'pmid': '25728241', 'type': 'BACKGROUND', 'citation': 'Pinzauti S, Lazzeri L, Tosti C, Centini G, Orlandini C, Luisi S, Zupi E, Exacoustos C, Petraglia F. Transvaginal sonographic features of diffuse adenomyosis in 18-30-year-old nulligravid women without endometriosis: association with symptoms. Ultrasound Obstet Gynecol. 2015 Dec;46(6):730-6. doi: 10.1002/uog.14834.'}, {'pmid': '31260048', 'type': 'BACKGROUND', 'citation': 'Shigesi N, Kvaskoff M, Kirtley S, Feng Q, Fang H, Knight JC, Missmer SA, Rahmioglu N, Zondervan KT, Becker CM. The association between endometriosis and autoimmune diseases: a systematic review and meta-analysis. Hum Reprod Update. 2019 Jul 1;25(4):486-503. doi: 10.1093/humupd/dmz014.'}, {'pmid': '25652685', 'type': 'BACKGROUND', 'citation': "Van den Bosch T, Dueholm M, Leone FP, Valentin L, Rasmussen CK, Votino A, Van Schoubroeck D, Landolfo C, Installe AJ, Guerriero S, Exacoustos C, Gordts S, Benacerraf B, D'Hooghe T, De Moor B, Brolmann H, Goldstein S, Epstein E, Bourne T, Timmerman D. Terms, definitions and measurements to describe sonographic features of myometrium and uterine masses: a consensus opinion from the Morphological Uterus Sonographic Assessment (MUSA) group. Ultrasound Obstet Gynecol. 2015 Sep;46(3):284-98. doi: 10.1002/uog.14806. Epub 2015 Aug 10."}, {'pmid': '16563868', 'type': 'BACKGROUND', 'citation': 'Vercellini P, Vigano P, Somigliana E, Daguati R, Abbiati A, Fedele L. Adenomyosis: epidemiological factors. Best Pract Res Clin Obstet Gynaecol. 2006 Aug;20(4):465-77. doi: 10.1016/j.bpobgyn.2006.01.017. Epub 2006 Mar 24.'}, {'pmid': '31954156', 'type': 'BACKGROUND', 'citation': 'Yu O, Schulze-Rath R, Grafton J, Hansen K, Scholes D, Reed SD. Adenomyosis incidence, prevalence and treatment: United States population-based study 2006-2015. Am J Obstet Gynecol. 2020 Jul;223(1):94.e1-94.e10. doi: 10.1016/j.ajog.2020.01.016. Epub 2020 Jan 15.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nAssessing 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.\n\nEndometriosis 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.\n\nTherefore, 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '29 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women of childbearing age, not pregnant, consulting for non-medical oocyte self-preservation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman aged between 29 and 37\n* Consultant for non-medical fertility preservation in the Reproductive Medicine Unit Port Royal, Cochin\n* Informed and not opposed to this research\n* Affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Pregnant women\n* Refusing to take part in the study\n* Under court protection, curatorship or guardianship\n* Women with a known malformation of the genital tract'}, 'identificationModule': {'nctId': 'NCT06211569', 'acronym': 'PrevADEOSE', 'briefTitle': 'Study of the Prevalence of Endometriosis and Adenomyosis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Study of the Prevalence of Endometriosis and Adenomyosis in Women of Childbearing Age Consulting for Non-medical Oocyte Self-preservation', 'orgStudyIdInfo': {'id': 'APHP231461'}, 'secondaryIdInfos': [{'id': '2023-A01474-41', 'type': 'OTHER', 'domain': 'France : Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Women of childbearing age, consulting for elective fertility preservation', 'interventionNames': ['Other: Usual follow-up']}], 'interventions': [{'name': 'Usual follow-up', 'type': 'OTHER', 'description': 'Usual follow-up', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathilde BOURDON, MD', 'role': 'CONTACT', 'email': 'mathilde.bourdon@aphp.fr', 'phone': '00331 58 41 39 20'}, {'name': 'Pietro SANTULLI', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mathilde BOURDON', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gynécologie Obstétrique II et médecine de la reproduction, Hôpital Cochin, Port Royal', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Mathilde BOURDON, MD', 'role': 'CONTACT', 'email': 'mathilde.bourdon@aphp.fr', 'phone': '00331 58 41 39 20'}, {'name': 'Marie Benhammani-Godard', 'role': 'CONTACT', 'email': 'marie.godard@aphp.fr', 'phone': '0033158411190'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}