Elective Fertility PreservationPrevADEOSENCT06211569
Study of the Prevalence of Endometriosis and Adenomyosis
An observational study of Elective Fertility Preservation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 to 37 years, women only
- Conditions the study is for
- Elective Fertility Preservation
- What is being tested?
- Usual follow-up
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2024to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 37 years
- Women only
- No healthy volunteers
- Adult
Study population: Women of childbearing age, not pregnant, consulting for non-medical oocyte self-preservation
Who may be able to join
- 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
Who cannot join
- Pregnant women
- Refusing to take part in the study
- Under court protection, curatorship or guardianship
- Women with a known malformation of the genital tract
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Gynécologie Obstétrique II et médecine de la reproduction, Hôpital Cochin, Port Royal
Paris, Île-de-France Region, 75014
Mathilde BOURDON, MD, 00331 58 41 39 20, mathilde.bourdon@aphp.fr
Pietro SANTULLI
About this study
Official title: Study of the Prevalence of Endometriosis and Adenomyosis in Women of Childbearing Age Consulting for Non-medical Oocyte Self-preservation
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.
Read the 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.
- Conditions
- Elective Fertility Preservation
- Being tested
- Usual follow-up
- Keywords
- Endometriosis, Adenomyosis, Prevalence, Elective fertility preservation, Transvaginal pelvic ultrasound
- Medical subject headings
- Endometriosis, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual follow-upOther
Usual follow-up
| Study group | Role | What they receive |
|---|---|---|
| Patients | Women of childbearing age, consulting for elective fertility preservation Receives: Other: Usual follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transvaginal pelvic ultrasound
Search for endometriosis and adenomyosis on transvaginal pelvic ultrasound and characterisation of lesions.
Measured: Up to month 6
Secondary outcomes (4)
Self-questionnaire
Socio-demographic data
Measured: Inclusion
Self-questionnaire
Medical history
Measured: Inclusion
Quality of life assessment (WHO-QOL-BREF)
Between 26 (Poor quality of life) and 130 (good quality of life)
Measured: Inclusion
Hospital Anxiety and Depression Scale (HADS)
2 scores between 0 (No anxiety or depression) and 21 (lots of anxiety and depression)
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start4 Apr 2024
- Primary completionJul 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Elective Fertility PreservationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211569
- Sponsor's protocol ID
- APHP231461
- Other IDs
- 2023-A01474-41
- Acronym
- PrevADEOSE
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 5059589Bordonne 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.
PubMed 34008384Bourdon 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.
PubMed 33491057Bourdon 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.
PubMed 34520877Bulun SE. Endometriosis. N Engl J Med. 2009 Jan 15;360(3):268-79. doi: 10.1056/NEJMra0804690. No abstract available.
PubMed 19144942Chapron 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.
PubMed 31488888Chapron 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.
PubMed 28510724Chapron 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.
PubMed 32097456Di 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.
PubMed 25201608Eisenberg VH, Arbib N, Schiff E, Goldenberg M, Seidman DS, Soriano D. Sonographic Signs of Adenomyosis Are Prevalent in Women Undergoing Surgery for Endometriosis and May Suggest a Higher Risk of Infertility. Biomed Res Int. 2017;2017:8967803. doi: 10.1155/2017/8967803. Epub 2017 Sep 18.
PubMed 29098162Fauconnier 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.
PubMed 16172113Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
PubMed 15541453Harmsen MJ, Van den Bosch T, de Leeuw RA, Dueholm M, Exacoustos C, Valentin L, Hehenkamp WJK, Groenman F, De Bruyn C, Rasmussen C, Lazzeri L, Jokubkiene L, Jurkovic D, Naftalin J, Tellum T, Bourne T, Timmerman D, Huirne JAF. Consensus on revised definitions of Morphological Uterus Sonographic Assessment (MUSA) features of adenomyosis: results of modified Delphi procedure. Ultrasound Obstet Gynecol. 2022 Jul;60(1):118-131. doi: 10.1002/uog.24786.
PubMed 34587658Hudelist 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.
PubMed 22990516Khan 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.
PubMed 31160242
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence of Endometriosis and Adenomyosis in Women of Childbearing Age Consulting for Non-medical Oocyte Self-preservation
- ClinicalTrials.gov ID
- NCT06211569
- Acronym / sponsor ID
- PrevADEOSE / APHP231461
- Conditions
- Elective Fertility Preservation
- Keywords
- Endometriosis, Adenomyosis, Prevalence, Elective fertility preservation, Transvaginal pelvic ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Usual follow-upWomen of childbearing age, consulting for elective fertility preservation |
Who may qualify
- Ages
- 29 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women of childbearing age, not pregnant, consulting for non-medical oocyte self-preservation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant women
- Refusing to take part in the study
- Under court protection, curatorship or guardianship
- Women with a known malformation of the genital tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual follow-upUsual follow-up | Other | Patients |
Primary outcome
Transvaginal pelvic ultrasound
Time frame: Up to month 6
Search for endometriosis and adenomyosis on transvaginal pelvic ultrasound and characterisation of lesions.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 5059589Bird 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.
- Background: PubMed 34008384Bordonne 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.
- Background: PubMed 33491057Bourdon 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.
- Background: PubMed 34520877Bourdon 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.
- Background: PubMed 19144942Bulun SE. Endometriosis. N Engl J Med. 2009 Jan 15;360(3):268-79. doi: 10.1056/NEJMra0804690. No abstract available.
- Background: PubMed 31488888Chapron 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.
- Background: PubMed 28510724Chapron 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.
- Background: PubMed 32097456Chapron 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.
- Background: PubMed 25201608Di 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.
- Background: PubMed 29098162Eisenberg VH, Arbib N, Schiff E, Goldenberg M, Seidman DS, Soriano D. Sonographic Signs of Adenomyosis Are Prevalent in Women Undergoing Surgery for Endometriosis and May Suggest a Higher Risk of Infertility. Biomed Res Int. 2017;2017:8967803. doi: 10.1155/2017/8967803. Epub 2017 Sep 18.
- Background: PubMed 16172113Fauconnier 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.
- Background: PubMed 15541453Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elective Fertility Preservation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde BOURDON, MD (00331 58 41 39 20, mathilde.bourdon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transvaginal pelvic ultrasound (time frame: Up to month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06211569, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.