[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ovarian-endometrioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ovarian-endometrioma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,64,93,116,145],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100644258","assessment-of-ovarian-reserve-in-the-treatment-of-ovarian-endometrioma-with-cystectomy-or-argon-plasma-coagulation-a-aandomized-clinical-trial-100644258",false,"NCT07666412","Assessment of Ovarian Reserve in the Treatment of Ovarian Endometrioma With Cystectomy or Argon Plasma Coagulation: A Aandomized Clinical Trial","Inclusion Criteria:\n\n* Symptomatic patients (pain and\u002For infertility) affected by ovarian endometriomas (unilateral or bilateral).\n* Age between 18 and 40 years.\n* Ultrasound diagnosis of one or more mono- or bilateral endometriotic cysts, with a maximum overall diameter (per ovary) ≤ 80 mm and at least one cyst diameter ≥ 20 mm.\n* Use of hormonal therapy for at least 1 month prior to surgery.\n* Willingness to undergo follow-up at 40-60 days and 12 months, according to clinical practice.\n* Willingness to receive postoperative hormonal therapy, according to clinical practice, to minimize the risk of recurrence.\n* Written informed consent obtained.\n\nExclusion Criteria:\n\n* History of unilateral ovariectomy\u002Fadnexectomy or hysterectomy.\n* Ultrasound evidence of other non-endometriotic ovarian cysts requiring surgical removal.\n* Atypical endometrioma or ultrasound suspicion of malignancy.\n* Previous surgery on one or both ovaries within 12 months prior to surgery.\n* Known or suspected active oncological disease.\n* Inability to undergo transvaginal ultrasound examination (patients with intact hymen).","FEMALE","18 Years","40 Years",{"count":19,"type":20},146,"ESTIMATED","INTERVENTIONAL",[23],"NA","Endometriosis is a benign, chronic, and often recurrent gynecological disease affecting approximately 10% of women of reproductive age. Among the different manifestations of the disease, ovarian endometrioma represents one of the most common forms, occurring in up to 50% of affected patients. Endometriomas may cause progressive damage to ovarian tissue through both mechanical effects and direct toxic effects related to the inflammatory and oxidative content of the cyst, ultimately leading to a reduction in ovarian reserve.\n\nWhen medical treatment is insufficient or not indicated, surgery represents a therapeutic option. The aim of surgery is to remove the cyst while minimizing the risk of recurrence and preserving as much healthy ovarian tissue as possible. Currently, the most widely used surgical technique is laparoscopic cystectomy performed by stripping the cyst capsule. However, this procedure may result in the inadvertent removal of healthy ovarian tissue and a consequent reduction in ovarian reserve.\n\nIn recent years, ablative surgical techniques have been developed with the aim of reducing damage to the ovarian parenchyma. Among these, Argon Plasma Coagulation (APC) is a technique that uses a high-energy argon plasma jet to vaporize and coagulate superficial tissues. From a histological perspective, APC induces limited-depth tissue necrosis, generally confined to the cyst capsule, potentially reducing the risk of damage to the underlying ovarian tissue. In addition, this technology may offer practical and economic advantages.\n\nSeveral studies suggest that ablative techniques may have a lower impact on ovarian reserve compared with cystectomy, as assessed by antral follicle count and serum anti-Müllerian hormone (AMH) levels, a reliable biomarker of ovarian reserve. However, the available evidence mainly derives from observational studies or studies using ablative technologies different from the one investigated in the present study. Furthermore, the systematic use of ablative techniques remains controversial in clinical practice, partly because of the potential risk of recurrence associated with residual endometriotic tissue.\n\nTo date, no randomized clinical trials have directly compared the impact of APC versus cystectomy on ovarian reserve in patients with ovarian endometrioma. Moreover, data are lacking regarding recurrence risk, post-treatment ovarian ultrasound characteristics following APC ablation, and the histological effects of this technique on endometriotic cysts.\n\nIn light of these considerations, the present randomized clinical trial aims to compare the effect of cystectomy and Argon Plasma Coagulation ablation on the preservation of ovarian reserve in patients undergoing surgical treatment for ovarian endometrioma, while also evaluating ultrasound outcomes and recurrence risk during follow-up.",[26],"Ovarian Endometrioma","NOT_YET_RECRUITING","2026-06-19",{"date":30,"type":31},"2026-06-24","ACTUAL",{"date":33,"type":20},"2026-06-08",{"date":35,"type":20},"2029-12-08",{"name":37,"class":38},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":48,"targetDuration":50,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100643762","histological-evaluation-of-dual-wavelength-diode-laser-ablation-of-ovarian-endometrioma-100643762","NCT07635199","Histological Evaluation of Dual-wavelength Diode Laser Ablation of Ovarian Endometrioma","Histological Evaluation of Ovarian Endometrioma Ablation Using a Dual-wavelength Diode Laser (LEONARDO® DUAL 45): a Pilot Study","DUALENDO","Inclusion Criteria:\n\n* Female participants aged 18 years or older\n* Ultrasound diagnosis of at least one unilateral or bilateral ovarian endometrioma measuring ≥3 cm in maximum diameter\n* Scheduled for laparoscopic surgery (cystectomy or adnexectomy)\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Suspected ovarian malignancy based on preoperative clinical or imaging evaluation\n* Presence of concomitant pelvic disease requiring complex surgical management or potentially interfering with histological assessment (e.g., pelvic inflammatory disease)\n* Medical conditions contraindicating laparoscopic surgery\n* Inability or unwillingness to provide written informed consent",{"count":49,"type":20},30,"6 Months","OBSERVATIONAL","Background: Ovarian endometrioma is the most common manifestation of endometriosis and is associated with chronic pelvic pain, infertility, and reduced ovarian reserve. Surgical treatment options include cystectomy and ablative techniques. Recent evidence suggests that ablative approaches may better preserve ovarian reserve compared with cystectomy while maintaining comparable recurrence and pregnancy rates. However, limited histological data are available regarding the depth of tissue damage induced by ablative techniques and their ability to completely eradicate endometriotic tissue.\n\nObjective: This pilot study aims to histologically evaluate the effects of ex vivo ovarian endometrioma ablation using the LEONARDO® DUAL 45 dual-wavelength diode laser (980 nm and 1470 nm). The study will assess the completeness of endometriotic tissue ablation, the depth of laser-induced necrosis within the endometrioma pseudocapsule, and the extent of thermal injury to the surrounding ovarian tissue.\n\nMethods: Adult women undergoing laparoscopic surgery for unilateral or bilateral ovarian endometriomas ≥3 cm will be prospectively enrolled. Surgical treatment will consist of cystectomy in reproductive-age women and adnexectomy in selected peri- or postmenopausal women according to routine clinical practice. After surgical excision, ex vivo samples of the internal endometrioma wall will undergo laser ablation using two different laser settings. Histological examination will evaluate residual endometrial glands and stroma, depth of necrosis, and thermal damage to adjacent ovarian tissue. Clinical, surgical, and pathological data will also be collected.\n\nStudy Design: Prospective, observational, pilot study involving a medical device. Approximately 30 patients will be enrolled, generating multiple histological specimens for analysis. The study is designed to provide preliminary evidence regarding the histological efficacy and tissue effects of dual-wavelength diode laser ablation of ovarian endometriomas.",[26,54],"Endometriosis","2026-06-03",{"date":57,"type":31},"2026-06-09",{"date":59,"type":20},"2026-06-07",{"date":61,"type":20},"2027-12-30",{"name":63,"class":38},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":15,"minAge":72,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":39},"100609480","selective-removal-of-endometriotic-lesions-using-cusa-clarity-in-ovarian-endometriomas-100609480","NCT07215130","Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas","Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas: A Case-Based Histopathological Study","CUSA-ENDO","Inclusion Criteria:\n\n* Female patients diagnosed with ovarian endometrioma who undergo surgical treatment (cystectomy or adnexectomy) at Kanazawa University Hospital between January 1, 2025, and March 31, 2027.\n* Written informed consent obtained prior to study participation.\n* Age ≥ 20 years at the time of consent.\n* For patients with previously stored endometrioma specimens under a broad consent, additional written consent for participation in this study will be obtained.\n\nExclusion Criteria:\n\n* Patients with suspected malignancy based on preoperative imaging.\n* Patients judged by the attending physician to be unsuitable for participation in this study for any reason.","20 Years",{"count":74,"type":20},10,"This study aims to evaluate the feasibility and tissue selectivity of a novel surgical technology, the Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity, in the management of ovarian endometriomas. Ovarian endometriomas are cysts caused by endometriosis that can damage ovarian reserve when treated by conventional surgery. In this study, ovarian cyst wall specimens are examined ex vivo using different Tissue Select settings of the CUSA device. Histopathological analyses are performed to determine whether endometriotic epithelium can be selectively removed while preserving normal ovarian tissue. The findings may contribute to developing fertility-preserving surgical approaches for women with endometriomas.",[26,54],[54,78,79,80,81,82],"Ovarian Cyst","CUSA Clarity","Ultrasonic Surgical Aspirator","Fertility Preservation","Histopathology","RECRUITING","2025-10-01",{"date":86,"type":31},"2025-10-10",{"date":88,"type":31},"2025-01-30",{"date":90,"type":20},"2028-03-31",{"name":92,"class":38},"Kanazawa University",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":39},"100593324","non-inferiority-trial-comparing-vaginal-ultrasound-guided-ethanol-sclerotherapy-and-laparoscopic-cystectomy-for-the-management-of-ovarian-endometriomas-e-step-100593324","NCT07004959","Non-inferiority Trial Comparing Vaginal Ultrasound-guided Ethanol Sclerotherapy and Laparoscopic Cystectomy for the Management of Ovarian Endometriomas (E-STEP)","Randomised Controlled Non-inferiority Trial Comparing Vaginal Ultrasound-guided Ethanol Sclerotherapy and Laparoscopic Cystectomy for the Management of Ovarian Endometriomas","E-STEP","Inclusion Criteria:\n\n* Patients aged between 18 and 45\n* Endometrioma diagnosed by endovaginal ultrasound or MRI (examinations carried out by a radiologist or gynaecologist) with a typical appearance and whose largest diameter is between 3 and 10 centimetres.\n* Pain (dysmenorrhoea or chronic pelvic pain) with a VAS greater than 30 millimetres, assessed by the question \"Indicate the subjective level of your endometriosis-related pain over the last 4 weeks\".\n\nExclusion Criteria:\n\n* Inability to speak French\n* Refusal to take part in the study\n* Risk factors for impaired ovarian reserve:\n* Ovarian reserve already low (AMH \\\u003C1,5ng\u002Fml or Antral follicle count \\\u003C 7 on the contralateral ovary\n* Bilateral or multiple endometriomas (two or more endometriomas greater than 3 centimetres in diameter).\n* Previous cystectomy\n* Previous major peritoneal surgery causing adhesions.\n* Contraindication to sclerotherapy : allergy to ethanol\n* Contraindications to general anaesthesia\n* Pregnant women, women in labour and nursing mothers","45 Years",{"count":103,"type":20},64,[23],"Endometriosis is a disease that affects between 6 and 10% of women of childbearing age. It is defined by the presence of endometrial tissue outside the uterine cavity, most often in the ovaries or the peritoneal cavity.\n\nThe standard treatment for endometriomas is laparoscopic intraperitoneal cystectomy. This treatment has been shown to be associated with a lower rate of recurrence of painful symptoms than simple cyst drainage, and with higher pregnancy rates. Nevertheless, cystectomy can lead to a reduction in ovarian reserve due to the removal of adjacent healthy ovarian tissue, particularly when there is no cleavage plane between the ovary and the endometrioma.\n\nOther methods have been developed to manage endometriomas while preserving the ovarian reserve. Endometrioma sclerotherapy is one of the most promising techniques for reducing the risk of recurrence while preserving the ovarian reserve. This technique involves injecting a sclerosing agent into the cystic cavity, which has been drained beforehand, in order to create an abrasion of the cystic epithelium, resulting in inflammation and fibrosis that can lead to the permanent destruction of the cyst.\n\nThe aim of the study is to conduct a single-centre randomised controlled non-inferiority trial comparing sclerotherapy and intraperitoneal cystectomy for the treatment of endometriomas.\n\nThe main hypothesis of the study is that sclerotherapy is not inferior to cystectomy in terms of reducing painful symptoms one year after the operation and that it is superior to cystectomy on one or more of the following criteria: preservation of ovarian reserve, operative complications, post-operative pain, patient acceptability\u002Fsatisfaction.\n\nThe number of patients to be included will be 64, calculated to demonstrate non-inferiority between sclerotherapy and cystectomy for the primary endpoint.",[26],"2025-05-26",{"date":109,"type":31},"2025-06-04",{"date":111,"type":31},"2024-11-19",{"date":113,"type":20},"2028-03-19",{"name":115,"class":38},"Assistance Publique Hopitaux De Marseille",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":39},"100503620","phase-4-estetroldrospirenone-to-reduce-the-average-size-of-endometriomas-100503620","NCT05837624","Estetrol\u002FDrospirenone to Reduce the Average Size of Endometriomas","ERASE","Inclusion Criteria:\n\n* Equal to or greater than 18 years old\n* Has at least one ovarian endometrioma, of at least 3 cm\n* Seeking a hormonal treatment for their endometrioma(s)\n\nExclusion criteria:\n\n* Any allergy or contraindication to the study drug\n* Inability to provide informed consent\n* Any hormone use, from the following list, within last 3 months (excluding hormones used for ovarian stimulation for fertility treatments): Estrogen (agonist or antagonist), Progestogen (agonist or antagonist), Androgen (agonist or antagonist), GnRH (agonist or antagonist), Cabergoline",{"count":124,"type":20},21,[126],"PHASE4","Endometriosis, a chronic gynecological disorder associated with pain and infertility, is a common condition affecting approximately one in ten women. Up to 50% of patients with endometriosis have ovarian endometriomas (or \"chocolate cysts\"). These cysts directly impact fertility and ovarian reserve (ie. ability to have children) and can cause additional symptoms in women such as added pain, discomfort, and surgical emergencies (cyst rupture, or more rarely twisting). While endometriomas tend to require surgical excision as a solution, medical management with a variety of medications has been shown to be effective in reducing their size.\n\nMedical management (ie. medications and treatments that don't involve surgery) to reduce cyst size can help relieve symptoms either as a long term solution, before fertility treatments, or temporarily until surgery can be offered. Because the COVID-19 pandemic caused significantly reduced access to surgery and resources, medical management has become important for relief of the overburdened healthcare network.\n\nThe purpose of this study is to see how effective Estetrol\u002Fdrospirenone, a combined oral contraceptive (COC), is in the reduction of ovarian endometriomas after a 3- and 6-month period of treatment.\n\nThis single arm interventional study will recruit women 18 years or older with an ovarian endometrioma of at least 3cm, who are seeking a hormonal treatment for their endometrioma(s). Consenting participants of the study will take Estetrol\u002Fdrospirenone once daily, orally, for a 6 month duration. An ultrasound assessment of ovarian endometrioma(s) will be performed before starting the drug (0 months), and will be repeated at 3-months and 6-months time. At each of these hospital visits (0, 3 \\& 6 months), participants will have their weight and blood pressure measured, and they will complete questionnaires regarding their endometriosis symptoms, incidence of amenorrhea, compliance and incidence of any adverse effects.",[26,129],"Endometrioma",[131,132,54,133,134,135],"Estetrol\u002Fdrospirenone","Nextstellis","volume reduction","ultrasound","Estetrol-drospirenone","2025-04-03",{"date":138,"type":31},"2025-04-06",{"date":140,"type":31},"2024-12-03",{"date":142,"type":20},"2026-12",{"name":144,"class":38},"Andrew Zakhari",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":155,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":4},"100340848","surgery-and-art-for-endometrioma-100340848","NCT03717870","Surgery and ART For Endometrioma","Evaluation of Reproductive Outcomes After Different Management of Ovarian Endometrioma Prior to Assisted Reproduction Technology (ART): Laparoscopic Enucleation Vs Prolonged Pituitary Downregulation With Gonadotropin Releasing Hormone (GnRH)-Agonists","Inclusion Criteria:\n\n* Indication for ART: compromised tubal function, male factor infertility, other treatments have failed and\u002For prolonged infertility of more than 4 years.\n* Age between 18 and 35 years.\n* Ultrasound diagnosis of one ovarian endometriotic cyst with a diameter of 30 mm or more, according to the International Ovarian Tumor Analysis (IOTA)-criteria for reliable diagnosis of endometriomas in premenopausal women.\n\nExclusion Criteria:\n\n* Any comorbidity other than ovarian endometrioma.\n* Deep Infiltrating Endometriosis.\n* Previous ovarian surgery.\n* Bilateral endometriomas.\n* The use of donor oocytes\u002Fsperm.\n* ART with preimplantation genetic testing, as the number of embryos suitable. for transfer or cryopreservation is significantly lower compared to normal ART.","35 Years",{"count":154,"type":20},100,[23],"Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of endometrial-like tissue, glands and stroma outside the uterine cavity. Although endometriosis is classified in four stage (minimal, mild, moderate, severe), from the clinical point of view it is possible to subdivide among peritoneal superficial lesions, ovarian endometriomas and Deep Infiltrating Endometriosis (DIE).\n\nAccording to the European Society for Human Reproduction and Embryology (ESHRE) Guideline on the management of women with endometriosis, it is recommended to clinicians that in infertile women with endometrioma larger than 3 cm, cystectomy should be considered prior to Assisted Reproduction Technology (ART) to improve endometriosis-associated pain or the accessibility of follicles. They further recommend that clinicians counsel women with endometrioma regarding the risks of reduced ovarian function after surgery, the possible loss of the ovary, and consider that the decision to proceed with surgery should be taken carefully if the woman has had previous ovarian surgery.\n\nIn addition, this Guideline suggests that clinicians can prescribe prolonged (3-6 months) pituitary downregulation with Gonadotropin Releasing Hormone-agonists (GnRH-a) prior to ART, in order to increase live birth rate by four-fold.\n\nDespite these recommendations, to date there is not robust evidence to choose between the two strategies prior to ART in order to improve reproductive outcomes.\n\nFor this reason, the aim of the current study will be to compare reproductive outcomes in infertile women affected by ovarian endometrioma, undergoing laparoscopic enucleation or prolonged pituitary downregulation with GnRH-a, prior to ART.",[26,158],"Infertility, Female",[129,160,161,162,163,164],"Infertility","Laparoscopy","GnRH-a","Assisted Reproduction Technology","Reproductive outcomes","2021-04-28",{"date":167,"type":31},"2021-04-29",{"date":169,"type":20},"2023-10",{"date":171,"type":20},"2027-10",{"name":173,"class":38},"Università degli Studi dell'Insubria"]