An observational study in Deep Infiltrating Endometriosis, Pelvic Pain, Dysmenorrhea Dyspareunia, sponsored by Başakşehir Çam & Sakura City Hospital. Completed at 2 sites in Turkey (Türkiye). Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Başakşehir Çam & Sakura City Hospital · Observational
Among 81 studies in Dysmenorrhea with a site in Turkey — 19 open to participants now, 23 under way, none of them phase 3. Dysmenorrhea · Turkey.
Among the 81 studies in Dysmenorrhea with a site in Turkey, this one is one of 7 that started in 2022, is one of 9 observational ones, and was the 65th registered.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
Browse Dysmenorrhea studies →19 of the 81 studies in Dysmenorrhea with a site in Turkey are open now. Recruiting first, the newest first:
Tokat Gaziosmanpasa University · Sites in Turkey
Istanbul Medipol University Hospital · Sites in Turkey
Ankara University · Sites in Turkey
Nigde Omer Halisdemir University · Sites in Turkey
Acibadem University · Sites in Turkey
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 57 Dysmenorrhea studies recruiting now, 7 (12%) set no upper age limit and 49 (86%) stop at 75 or younger; 11 take children under 18; 20 take healthy volunteers.
This study: 18 Years to 55 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
81 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 7 started in 2022.
This study's enrollment of 65 is below the median of 107 across 58 observational studies indexed under Dysmenorrhea.
Median enrollment 60 across the 72 interventional studies, 60 across the 9 observational. Of the 52 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 81 has an industry lead sponsor. The 10 most frequent:
Başakşehir Çam & Sakura City Hospital is the lead sponsor of 109 studies on the registry; 36 are open to participants now.
Başakşehir Çam & Sakura City Hospital has 1 study filed under Dysmenorrhea — fewer than ten, so there is no comparison to draw.
3 of the studies in Dysmenorrhea with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07731243Istanbul Medipol University HospitalVibration, Massage, and Myofascial Release in Primary Dysmenorrhea | 2026-11-15 |
| NCT06398990Acibadem UniversityThe Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea | 2026-12 |
| NCT07409337Nigde Omer Halisdemir UniversitySelf-Acupressure for Primary Dysmenorrhea and Premenstrual Symptoms | 2026-12-15 |
Among the 81 studies in Dysmenorrhea with a site in Turkey, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's enrollment of 65 is below the median of 107 across 58 observational studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Başakşehir Çam & Sakura City Hospital is the lead sponsor of 109 studies on the registry; 36 are open to participants now.
Compared within Dysmenorrhea, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pelvic Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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 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 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
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: from 01.02.2022 to june 2025
Plan to share: No — This retrospective, single-cohort study uses de-identified data from routine care and archived tissue. Individual participant data will not be shared publicly.
Ran from Feb 2022 to primary completion in Jun 2025, 40 months.
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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