Endometrioma Clinical Trial
— OMAlaserOfficial title:
Ovarian Reserve, Recurrence Rate and Histopathologic Evaluation After DWLS Diode Laser Vaporization of Ovarian Endometriomas: Results From a Prospective, Multicentre, Clinical Trial.
Verified date | January 2024 |
Source | University of Cagliari |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
PURPOSE OF THE STUDY The study aims to evaluate the effectiveness of the Dual Wavelength Laser System (DWLS) diode laser on the treatment of endometrioma (OMA), with ablation and vaporization of the cystic capsule without performing the stripping technique, in terms of ovarian reserve and recurrence rate.
Status | Completed |
Enrollment | 70 |
Est. completion date | September 1, 2023 |
Est. primary completion date | March 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Age between 18 and 40 years old - OMA mono or bilateral = 3 and = 8 cm in diameter - presence of symptoms such as pelvic pain and sterility Exclusion Criteria: - Patients who are unable to provide written informed consent or to follow the procedures provided for by the protocol - Age <18 years and> 40 years - OMA mono or bilateral <3 and> 8 cm in diameter - Asymptomatic patients - Absence of histological confirmation of endometriosis cysts - previous interventions on one or both annexes - Failure to follow-up |
Country | Name | City | State |
---|---|---|---|
Italy | University of Cagliari,Obstetrics and Gynecological Department | Monserrato | Cagliari |
Lead Sponsor | Collaborator |
---|---|
University of Cagliari | Azienda Ospedaliera per l'Emergenza Canizzaro, University of Foggia |
Italy,
Angioni S, Pontis A, Sorrentino F, Nappi L. Bilateral salpingo-oophorectomy and adhesiolysis with single port access laparoscopy and use of diode laser in a BRCA carrier. Eur J Gynaecol Oncol. 2015;36(4):479-81. — View Citation
Benschop L, Farquhar C, van der Poel N, Heineman MJ. Interventions for women with endometrioma prior to assisted reproductive technology. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD008571. doi: 10.1002/14651858.CD008571.pub2. — View Citation
Candiani M, Ottolina J, Posadzka E, Ferrari S, Castellano LM, Tandoi I, Pagliardini L, Nocun A, Jach R. Assessment of ovarian reserve after cystectomy versus 'one-step' laser vaporization in the treatment of ovarian endometrioma: a small randomized clinical trial. Hum Reprod. 2018 Dec 1;33(12):2205-2211. doi: 10.1093/humrep/dey305. — View Citation
Ceccaroni M, Bounous VE, Clarizia R, Mautone D, Mabrouk M. Recurrent endometriosis: a battle against an unknown enemy. Eur J Contracept Reprod Health Care. 2019 Dec;24(6):464-474. doi: 10.1080/13625187.2019.1662391. Epub 2019 Sep 25. — View Citation
Donnez J, Lousse JC, Jadoul P, Donnez O, Squifflet J. Laparoscopic management of endometriomas using a combined technique of excisional (cystectomy) and ablative surgery. Fertil Steril. 2010 Jun;94(1):28-32. doi: 10.1016/j.fertnstert.2009.02.065. Epub 2009 Apr 9. — View Citation
Dunselman GA, Vermeulen N, Becker C, Calhaz-Jorge C, D'Hooghe T, De Bie B, Heikinheimo O, Horne AW, Kiesel L, Nap A, Prentice A, Saridogan E, Soriano D, Nelen W; European Society of Human Reproduction and Embryology. ESHRE guideline: management of women with endometriosis. Hum Reprod. 2014 Mar;29(3):400-12. doi: 10.1093/humrep/det457. Epub 2014 Jan 15. — View Citation
Guo SW. Recurrence of endometriosis and its control. Hum Reprod Update. 2009 Jul-Aug;15(4):441-61. doi: 10.1093/humupd/dmp007. Epub 2009 Mar 11. — View Citation
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Seo JW, Lee DY, Yoon BK, Choi D. The age-related recurrence of endometrioma after conservative surgery. Eur J Obstet Gynecol Reprod Biol. 2017 Jan;208:81-85. doi: 10.1016/j.ejogrb.2016.11.015. Epub 2016 Nov 16. — View Citation
Tsolakidis D, Pados G, Vavilis D, Athanatos D, Tsalikis T, Giannakou A, Tarlatzis BC. The impact on ovarian reserve after laparoscopic ovarian cystectomy versus three-stage management in patients with endometriomas: a prospective randomized study. Fertil Steril. 2010 Jun;94(1):71-7. doi: 10.1016/j.fertnstert.2009.01.138. Epub 2009 Apr 25. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of the ovarian reserve using AntiMullerian Hormone (AMH) assessment. | Blood dosage of AntiMullerian Hormone expressed in nanograms/milliliter (ng/mL) | every 3 months for one year | |
Primary | Evaluation of the ovarian reserve using Antral follicular Count (AFC) | counts of the number of antral follicles present in the ovary during ultrasound scan. The count is presented in Numbers from 0 to any numbers (n°) | every 3 months for one year | |
Primary | Evaluation of the patients' symptoms | assessed using the Visual Analogue Scale (VAS) , from 0 as the minimum to 10 as maximum value. Higher scores mean a worse outcome | every 3 months for one year | |
Secondary | Evaluation of endometrioma recurrence rate | Ultrasound scan Evaluation of OMA recurrence. Assessed using a percentage (%) of patients who present the endometrioma in the ovaries after surgery | every 3 months for one year | |
Secondary | Evaluation of pregnancy rate | Assessed as percentage (%) of patients who achieved pregnancy after surgery | every 3 months for one year |
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