Deep Infiltrating Endometriosis, Pelvic Pain, Dysmenorrhea DyspareuniaDIENerveDensNCT07274956
Nerve Fiber Density in DIE Nodules & Pelvic Pain
An observational study of Deep Infiltrating Endometriosis, Pelvic Pain, Dysmenorrhea Dyspareunia, run by Başakşehir Çam & Sakura City Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Deep infiltrating endometriosis (DIE) is a highly symptomatic form of endometriosis linked to severe dysmenorrhea, dyspareunia, dyschezia, dysuria, and chronic pelvic pain. Histologic studies suggest abundant neural elements in DIE nodules, but the relationship between nodule-level nerve fiber density and… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Deep Infiltrating Endometriosis, Pelvic Pain, Dysmenorrhea Dyspareunia
- How many people
- 65 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 27 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged 18-55 with surgically confirmed deep infiltrating endometriosis (DIE) treated at tertiary referral endometriosis centers during the study period. Consecutive, real-world all-comer surgical cases are included after inadequate response to medical therapy, encompassing common DIE sites (rectovaginal septum, uterosacral/cardinal ligaments, parametria, retrocervical/cervicovaginal, bowel, ureter, bladder). All participants have archived FFPE specimens suitable for histopathology/IHC and a documented preoperative pain assessment (e.g., VAS). The cohort is observational, retrospective, with no investigational intervention.
Inclusion Criteria:Female, 18-55 years of age at time of surgery
Surgically treated for deep infiltrating endometriosis (DIE) with curative intent within the study period
Histopathologic confirmation of DIE on resected specimen (e.g., rectovaginal septum, uterosacral/cardinal ligaments, parametria, bowel, ureter, bladder, retrocervical/cervicovaginal sites)
Availability of archived FFPE tissue blocks adequate for H\&E and immunohistochemistry (e.g., SOX10) to quantify nerve fiber density
Documented preoperative pain assessment (e.g., VAS 0-10 for dysmenorrhea, dyspareunia, dyschezia, dysuria, and/or chronic pelvic pain) obtained within ≤3 months prior to index surgery
Accessible clinical data in the medical record (demographics, gynecologic history, prior medical/surgical therapies) sufficient for planned analyses
IRB approval in place; inclusion under written informed consent or IRB waiver applicable to retrospective data/tissue use -
Exclusion Criteria:No surgical resection of DIE (e.g., diagnostic laparoscopy only) or no histopathologic confirmation of DIE
Insufficient biospecimen (no/poor-quality FFPE tissue for H\&E/IHC)
Missing preoperative pain assessment (no VAS data within ≤3 months before index surgery)
Concomitant malignancy of the pelvis/abdominopelvic organs or malignancy treated within the past 5 years
Prior pelvic radiotherapy or major pelvic/nerve ablative surgery that precludes meaningful pain attribution
Acute pelvic infection at time of assessment or surgery (e.g., PID, tubo-ovarian abscess)
Primary pain disorders likely to confound attribution (e.g., interstitial cystitis/bladder pain syndrome, IBS with pain as dominant symptom, centrally mediated chronic pain syndromes) without adequate documentation to separate pain sources
-
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Basaksehir Cam Ve Sakura Sehir Hospital
Istanbul, 34060
Basaksehir Cam ve Sakura City Hospital, Başakşehir Mahallesi G-434 Caddesi No: 2L Başakşehir / İSTANBUL
Istanbul, 34480
About this study
Official title: Is Pelvic Pain Severity Correlated With Nerve Fiber Density Within DIE Nodules?
Deep infiltrating endometriosis (DIE) is a highly symptomatic form of endometriosis linked to severe dysmenorrhea, dyspareunia, dyschezia, dysuria, and chronic pelvic pain. Histologic studies suggest abundant neural elements in DIE nodules, but the relationship between nodule-level nerve fiber density and patient-reported pelvic pain remains insufficiently defined. This retrospective, cross-sectional study with prospective pathology re-review evaluates whether nerve fiber density in surgically excised DIE nodules correlates with pain severity and location. Women aged 18-55 who underwent surgery for DIE after inadequate response to medical therapy are included. Clinical data (demographics, gynecologic history, prior treatments) and standardized pain scores (VAS for pain domains) are abstracted from records. Archived blocks are recut; sections are stained with H\&E and immunolabeled (e.g., SOX-10) to quantify neural profiles and derive a nerve fiber density metric per nodule. Primary endpoint: association between nerve fiber density and pain intensity/localization. Secondary endpoints: relationships with lesion site/depth and other clinicopathologic variables; exploratory discrimination of severe-pain phenotypes. Statistics (χ²/Fisher, t/Mann-Whitney, Kaplan-Meier/Cox if applicable) use two-sided p<0.05. This minimal-risk study uses existing records and archived tissue only; findings may inform counseling, nerve-sparing surgical planning, and future biomarker-driven, response-adapted trials.
Read the detailed description
Deep infiltrating endometriosis (DIE) is a highly symptomatic phenotype of endometriosis that invades retrocervical, parametrial, rectovaginal, bowel, and other pelvic structures, and is frequently associated with severe dysmenorrhea, dyspareunia, dyschezia, dysuria, and chronic pelvic pain. Emerging evidence suggests that DIE nodules harbor abundant nerve fibers and may show perineural involvement, yet the relationship between intranodular nerve fiber density and patient-reported pelvic pain has not been defined with sufficient clinical granularity.
This retrospective, cross-sectional study with prospective pathology re-review investigates whether nerve fiber density within surgically excised DIE nodules correlates with the intensity and localization of pelvic pain. Eligible participants are women (18-55 years) operated for DIE after inadequate response to medical therapy (e.g., nodule excision, nerve-sparing hysterectomy ± salpingo-oophorectomy, ovarian surgery, and/or bowel resection when indicated). Demographic characteristics, obstetric/gynecologic history, prior surgeries and medical treatments, and standardized pain assessments (visual analogue scale [VAS] scores for dysmenorrhea, dyspareunia, dyschezia, dysuria, and chronic pelvic pain) are abstracted from the hospital information system.
All resected specimens are routinely fixed in buffered formalin and processed for histopathology. For this study, archived blocks from endometriotic foci are recut (3-µm sections) and stained with hematoxylin-eosin and immunohistochemically labeled with SOX-10 to visualize neural elements. Under ×200 magnification, the number of SOX-10-positive neural profiles within endometriotic foci is quantified, and mean nerve fiber counts (per evaluated field/area) are calculated to derive a nerve fiber density metric for each nodule. The primary endpoint is the association between nodule-level nerve fiber density and pain severity/localization. Secondary endpoints include associations with clinicopathologic variables (lesion site and depth, parametrial/rectovaginal/bowel involvement), and exploratory analyses of indices that may discriminate patients with severe pain.
Statistics will be performed with SPSS (v23). Categorical variables are summarized as n (%) and compared with χ² or Fisher's exact tests; continuous variables as mean ± SD (or median [min-max]) and compared with Student's t-test or Mann-Whitney U test as appropriate; within-group paired comparisons may use the Wilcoxon test. Two-sided p < 0.05 denotes statistical significance. Because this is a retrospective audit with predefined time frame and all-comer surgical inclusions, no formal sample size calculation is planned.
Risks/Benefits: This is minimal-risk research using archived pathology and existing clinical records; no additional procedures or changes to care are required. Results may clarify whether tissue-level neural metrics in DIE nodules reflect the patient's pain phenotype, potentially informing counseling, surgical planning (e.g., nerve-sparing strategies), and the development of response biomarkers for future prospective studies.
- Keywords
- Deep infiltrating endometriosis; Pelvic pain; Dysmenorrhea; Dyspareunia; Nerve fiber density; SOX10
- Medical subject headings
- Pelvic Pain, Dysmenorrhea, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DIE Nodule Pathology Cohort | Women (18-55 years) with surgically confirmed deep infiltrating endometriosis (DIE) who underwent standard-of-care resection (e.g., nodule excision, nerve-sparing hysterectomy ± salpingo-oophorectomy, and/or segmental bowel surgery when indicated). This is an observational, retrospective cohort; no investigational intervention is administered. The exposure of interest is nodule-level nerve fiber density, quantified on archived FFPE blocks by histopathology and immunohistochemistry (e.g., SOX10). Clinical data (demographics, gynecologic history, prior treatments) and patient-reported pain scores (VAS for dysmenorrhea, dyspareunia, dyschezia, dysuria, chronic pelvic pain) are abstracted from records. Primary analyses assess the association between nerve fiber density and pelvic pain severity/localization; secondary analyses explore relationships with lesion site/depth and other clinicopathologic features. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between nodule-level nerve fiber density and pelvic pain severity
Nerve fiber density (SOX10-positive neural profiles per high-power field on FFPE sections of DIE nodules) will be quantified and averaged per nodule. Pelvic pain severity will be extracted from patient-reported visual analogue scale (VAS, 0-10) scores for relevant domains (e.g., dysmenorrhea, dyspareunia, dyschezia, dysuria, chronic pelvic pain). The primary analysis tests the association between nerve fiber density and VAS severity (Spearman correlation and multivariable linear regression adjusting for age, lesion site/depth, and prior treatments). Higher nerve fiber density is hypothesized to correlate with higher VAS pain scores.
Measured: from 01.02.2022 to june 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Feb 2022
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Deep Infiltrating Endometriosis, Pelvic Pain, Dysmenorrhea DyspareuniaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Baris KAYA, Başakşehir Çam & Sakura City Hospital
- Investigators
- baris kaya, associate professor, Principal investigator, Basaksehir Cam ve Sakura Sehir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274956
- Sponsor's protocol ID
- 2025-214
- Other IDs
- The authors BK and SHA
- Acronym
- DIENerveDens
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This retrospective, single-cohort study uses de-identified data from routine care and archived tissue. Individual participant data will not be shared publicly.
Publications
Zomer MT, Kondo W, Cavalcanti TCS, Von Linsigen R, Ferreira LRG, Carranco RC, Trippia CH, Kulak J Jr. Assessment of Nerve Fiber Density and Expression of Hormonal Receptors Within Rectosigmoid Endometriosis Nodules. J Minim Invasive Gynecol. 2022 Feb;29(2):265-273. doi: 10.1016/j.jmig.2021.08.008. Epub 2021 Aug 17.
PubMed 34411730Tokushige N, Markham R, Russell P, Fraser IS. Nerve fibres in peritoneal endometriosis. Hum Reprod. 2006 Nov;21(11):3001-7. doi: 10.1093/humrep/del260. Epub 2006 Sep 1.
PubMed 16950827McKinnon B, Bersinger NA, Wotzkow C, Mueller MD. Endometriosis-associated nerve fibers, peritoneal fluid cytokine concentrations, and pain in endometriotic lesions from different locations. Fertil Steril. 2012 Feb;97(2):373-80. doi: 10.1016/j.fertnstert.2011.11.011. Epub 2011 Dec 10.
PubMed 22154765Wang G, Tokushige N, Markham R, Fraser IS. Rich innervation of deep infiltrating endometriosis. Hum Reprod. 2009 Apr;24(4):827-34. doi: 10.1093/humrep/den464. Epub 2009 Jan 16.
PubMed 19151028Yan D, Liu X, Guo SW. Neuropeptides Substance P and Calcitonin Gene Related Peptide Accelerate the Development and Fibrogenesis of Endometriosis. Sci Rep. 2019 Feb 25;9(1):2698. doi: 10.1038/s41598-019-39170-w.
PubMed 30804432Mabrouk M, Raimondo D, Arena A, Iodice R, Altieri M, Sutherland N, Salucci P, Moro E, Seracchioli R. Parametrial Endometriosis: The Occult Condition that Makes the Hard Harder. J Minim Invasive Gynecol. 2019 Jul-Aug;26(5):871-876. doi: 10.1016/j.jmig.2018.08.022. Epub 2018 Aug 31.
PubMed 30176361Koninckx PR, Meuleman C, Demeyere S, Lesaffre E, Cornillie FJ. Suggestive evidence that pelvic endometriosis is a progressive disease, whereas deeply infiltrating endometriosis is associated with pelvic pain. Fertil Steril. 1991 Apr;55(4):759-65. doi: 10.1016/s0015-0282(16)54244-7.
PubMed 2010001
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Pelvic Pain Severity Correlated With Nerve Fiber Density Within DIE Nodules?
- ClinicalTrials.gov ID
- NCT07274956
- Acronym / sponsor ID
- DIENerveDens / 2025-214
- Keywords
- Deep infiltrating endometriosis; Pelvic pain; Dysmenorrhea; Dyspareunia; Nerve fiber density; SOX10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 10 Dec 2025 (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.
Deep infiltrating endometriosis (DIE) is a highly symptomatic form of endometriosis linked to severe dysmenorrhea, dyspareunia, dyschezia, dysuria, and chronic pelvic pain. Histologic studies suggest abundant neural elements in DIE nodules, but the relationship between nodule-level nerve fiber density and patient-reported pelvic pain remains insufficiently defined. This retrospective, cross-sectional study with prospective pathology re-review evaluates whether nerve fiber density in surgically excised DIE nodules correlates with pain severity and location. Women aged 18-55 who underwent surgery for DIE after inadequate response to medical therapy are included. Clinical data (demographics, gynecologic history, prior treatments) and standardized pain scores (VAS for pain domains) are abstracted from records. Archived blocks are recut; sections are stained with H\&E and immunolabeled (e.g., SOX-10) to quantify neural profiles and derive a nerve fiber density metric per nodule. Primary endpoint: association between nerve fiber density and pain intensity/localization. Secondary endpoints: relationships with lesion site/depth and other clinicopathologic variables; exploratory discrimination of severe-pain phenotypes. Statistics (χ²/Fisher, t/Mann-Whitney, Kaplan-Meier/Cox if applicable) use two-sided p<0.05. This minimal-risk study uses existing records and archived tissue only; findings may inform counseling, nerve-sparing surgical planning, and future biomarker-driven, response-adapted trials.
Detailed description
Deep infiltrating endometriosis (DIE) is a highly symptomatic phenotype of endometriosis that invades retrocervical, parametrial, rectovaginal, bowel, and other pelvic structures, and is frequently associated with severe dysmenorrhea, dyspareunia, dyschezia, dysuria, and chronic pelvic pain. Emerging evidence suggests that DIE nodules harbor abundant nerve fibers and may show perineural involvement, yet the relationship between intranodular nerve fiber density and patient-reported pelvic pain has not been defined with sufficient clinical granularity.
This retrospective, cross-sectional study with prospective pathology re-review investigates whether nerve fiber density within surgically excised DIE nodules correlates with the intensity and localization of pelvic pain. Eligible participants are women (18-55 years) operated for DIE after inadequate response to medical therapy (e.g., nodule excision, nerve-sparing hysterectomy ± salpingo-oophorectomy, ovarian surgery, and/or bowel resection when indicated). Demographic characteristics, obstetric/gynecologic history, prior surgeries and medical treatments, and standardized pain assessments (visual analogue scale [VAS] scores for dysmenorrhea, dyspareunia, dyschezia, dysuria, and chronic pelvic pain) are abstracted from the hospital information system.
All resected specimens are routinely fixed in buffered formalin and processed for histopathology. For this study, archived blocks from endometriotic foci are recut (3-µm sections) and stained with hematoxylin-eosin and immunohistochemically labeled with SOX-10 to visualize neural elements. Under ×200 magnification, the number of SOX-10-positive neural profiles within endometriotic foci is quantified, and mean nerve fiber counts (per evaluated field/area) are calculated to derive a nerve fiber density metric for each nodule. The primary endpoint is the association between nodule-level nerve fiber density and pain severity/localization. Secondary endpoints include associations with clinicopathologic variables (lesion site and depth, parametrial/rectovaginal/bowel involvement), and exploratory analyses of indices that may discriminate patients with severe pain.
Statistics will be performed with SPSS (v23). Categorical variables are summarized as n (%) and compared with χ² or Fisher's exact tests; continuous variables as mean ± SD (or median [min-max]) and compared with Student's t-test or Mann-Whitney U test as appropriate; within-group paired comparisons may use the Wilcoxon test. Two-sided p < 0.05 denotes statistical significance. Because this is a retrospective audit with predefined time frame and all-comer surgical inclusions, no formal sample size calculation is planned.
Risks/Benefits: This is minimal-risk research using archived pathology and existing clinical records; no additional procedures or changes to care are required. Results may clarify whether tissue-level neural metrics in DIE nodules reflect the patient's pain phenotype, potentially informing counseling, surgical planning (e.g., nerve-sparing strategies), and the development of response biomarkers for future prospective studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DIE Nodule Pathology Cohort | – | –Women (18-55 years) with surgically confirmed deep infiltrating endometriosis (DIE) who underwent standard-of-care resection (e.g., nodule excision, nerve-sparing hysterectomy ± salpingo-oophorectomy, and/or segmental bowel surgery when indicated). This is an observational, retrospective cohort; no investigational intervention is administered. The exposure of interest is nodule-level nerve fiber density, quantified on archived FFPE blocks by histopathology and immunohistochemistry (e.g., SOX10). Clinical data (demographics, gynecologic history, prior treatments) and patient-reported pain scores (VAS for dysmenorrhea, dyspareunia, dyschezia, dysuria, chronic pelvic pain) are abstracted from records. Primary analyses assess the association between nerve fiber density and pelvic pain severity/localization; secondary analyses explore relationships with lesion site/depth and other clinicopathologic features. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged 18-55 with surgically confirmed deep infiltrating endometriosis (DIE) treated at tertiary referral endometriosis centers during the study period. Consecutive, real-world all-comer surgical cases are included after inadequate response to medical therapy, encompassing common DIE sites (rectovaginal septum, uterosacral/cardinal ligaments, parametria, retrocervical/cervicovaginal, bowel, ureter, bladder). All participants have archived FFPE specimens suitable for histopathology/IHC and a documented preoperative pain assessment (e.g., VAS). The cohort is observational, retrospective, with no investigational intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between nodule-level nerve fiber density and pelvic pain severity
Time frame: from 01.02.2022 to june 2025
Nerve fiber density (SOX10-positive neural profiles per high-power field on FFPE sections of DIE nodules) will be quantified and averaged per nodule. Pelvic pain severity will be extracted from patient-reported visual analogue scale (VAS, 0-10) scores for relevant domains (e.g., dysmenorrhea, dyspareunia, dyschezia, dysuria, chronic pelvic pain). The primary analysis tests the association between nerve fiber density and VAS severity (Spearman correlation and multivariable linear regression adjusting for age, lesion site/depth, and prior treatments). Higher nerve fiber density is hypothesized to correlate with higher VAS pain scores.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Background: PubMed 34411730Zomer MT, Kondo W, Cavalcanti TCS, Von Linsigen R, Ferreira LRG, Carranco RC, Trippia CH, Kulak J Jr. Assessment of Nerve Fiber Density and Expression of Hormonal Receptors Within Rectosigmoid Endometriosis Nodules. J Minim Invasive Gynecol. 2022 Feb;29(2):265-273. doi: 10.1016/j.jmig.2021.08.008. Epub 2021 Aug 17.
- Background: PubMed 16950827Tokushige N, Markham R, Russell P, Fraser IS. Nerve fibres in peritoneal endometriosis. Hum Reprod. 2006 Nov;21(11):3001-7. doi: 10.1093/humrep/del260. Epub 2006 Sep 1.
- Background: PubMed 22154765McKinnon B, Bersinger NA, Wotzkow C, Mueller MD. Endometriosis-associated nerve fibers, peritoneal fluid cytokine concentrations, and pain in endometriotic lesions from different locations. Fertil Steril. 2012 Feb;97(2):373-80. doi: 10.1016/j.fertnstert.2011.11.011. Epub 2011 Dec 10.
- Background: PubMed 19151028Wang G, Tokushige N, Markham R, Fraser IS. Rich innervation of deep infiltrating endometriosis. Hum Reprod. 2009 Apr;24(4):827-34. doi: 10.1093/humrep/den464. Epub 2009 Jan 16.
- Background: PubMed 30804432Yan D, Liu X, Guo SW. Neuropeptides Substance P and Calcitonin Gene Related Peptide Accelerate the Development and Fibrogenesis of Endometriosis. Sci Rep. 2019 Feb 25;9(1):2698. doi: 10.1038/s41598-019-39170-w.
- Background: PubMed 30176361Mabrouk M, Raimondo D, Arena A, Iodice R, Altieri M, Sutherland N, Salucci P, Moro E, Seracchioli R. Parametrial Endometriosis: The Occult Condition that Makes the Hard Harder. J Minim Invasive Gynecol. 2019 Jul-Aug;26(5):871-876. doi: 10.1016/j.jmig.2018.08.022. Epub 2018 Aug 31.
- Background: PubMed 2010001Koninckx PR, Meuleman C, Demeyere S, Lesaffre E, Cornillie FJ. Suggestive evidence that pelvic endometriosis is a progressive disease, whereas deeply infiltrating endometriosis is associated with pelvic pain. Fertil Steril. 1991 Apr;55(4):759-65. doi: 10.1016/s0015-0282(16)54244-7.
- Individual participant dataSharing planned: No. This retrospective, single-cohort study uses de-identified data from routine care and archived tissue. Individual participant data will not be shared publicly.
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. This study is not recruiting at the moment.
baris kaya, associate professor principal investigator
Basaksehir Cam ve Sakura Sehir Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Infiltrating Endometriosis, Pelvic Pain, Dysmenorrhea Dyspareunia, run by Başakşehir Çam & Sakura City Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between nodule-level nerve fiber density and pelvic pain severity (time frame: from 01.02.2022 to june 2025). 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 NCT07274956, which also lists 7 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 10 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.