Evaluation of Ovarian Reserve and Recurrence Rate After DWLS Diode Laser OMA Vaporization

NCT06219044 | Completed DMC

• 1 other identifier: OMA Diode Laser Vaporization
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrioma; Ovarian Endometriosis; Ovarian Endometrioma

Keywords

endometrioma; laparoscopy; diode laser

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Evaluation of endometrioma recurrence rate

  every 3 months for one year

• Evaluation of pregnancy rate

  every 3 months for one year

Study Arms (1)

symptomatic ovarian endometrioma

EXPERIMENTAL

patients aged between 18 and 40 years with clinical and/or ultrasound diagnosis of symptomatic ovarian endometrioma

Procedure: laparoscopic endometrioma laser vaporization

Interventions

laparoscopic endometrioma laser vaporization PROCEDURE

laser vaporization of ovarian endometrioma using a DWLS diode laser during a laparoscopy

symptomatic ovarian endometrioma

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: ovarian endometrioma
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cagliari: lead
• University of Foggia: collaborator
• Azienda Ospedaliera per l'Emergenza Canizzaro: collaborator

Study Sites (1)

University of Cagliari,Obstetrics and Gynecological Department

Monserrato, Cagliari, 09042, Italy

Location

Related Publications (12)

• Kennedy S, Bergqvist A, Chapron C, D'Hooghe T, Dunselman G, Greb R, Hummelshoj L, Prentice A, Saridogan E; ESHRE Special Interest Group for Endometriosis and Endometrium Guideline Development Group. ESHRE guideline for the diagnosis and treatment of endometriosis. Hum Reprod. 2005 Oct;20(10):2698-704. doi: 10.1093/humrep/dei135. Epub 2005 Jun 24.

  PMID: 15980014 BACKGROUND

• 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.

  PMID: 24435778 BACKGROUND

• 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;2010(11):CD008571. doi: 10.1002/14651858.CD008571.pub2.

  PMID: 21069706 BACKGROUND

• Practice Committee of the American Society for Reproductive Medicine. Endometriosis and infertility: a committee opinion. Fertil Steril. 2012 Sep;98(3):591-8. doi: 10.1016/j.fertnstert.2012.05.031. Epub 2012 Jun 15.

  PMID: 22704630 BACKGROUND

• 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.

  PMID: 19361793 BACKGROUND

• 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.

  PMID: 19393996 BACKGROUND

• Muzii L, Bellati F, Bianchi A, Palaia I, Manci N, Zullo MA, Angioli R, Panici PB. Laparoscopic stripping of endometriomas: a randomized trial on different surgical techniques. Part II: pathological results. Hum Reprod. 2005 Jul;20(7):1987-92. doi: 10.1093/humrep/deh851. Epub 2005 Apr 28.

  PMID: 15860498 BACKGROUND

• 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.

  PMID: 19279046 BACKGROUND

• 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.

  PMID: 31550940 BACKGROUND

• 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.

  PMID: 27894033 BACKGROUND

• 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.

  PMID: 30299482 BACKGROUND

• 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.

  PMID: 26390708 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 23, 2024
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)