Ozone Therapy for Women With Endometriosis

NCT07035522 | Not Yet Recruiting DMC

• 2 other identifiers: 7.499.29586719325.4.0000.0177
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the action of ozone therapy as an adjuvant treatment in patients with endometriosis. Secondary Objective: To evaluate the efficacy of ozone therapy for pelvic analgesia in women with endometriosis; To compare the imaging diagnostic techniques of transvaginal ultrasound with infrared thermography in the pre-treatment (before), fourth, seventh and post-treatment (10th session) periods; To evaluate the application of the consolidated questionnaire (EHP-30) in the changes in the quality of life of the participants immediately after the intervention.

Conditions

Endometriosis; Ozone Therapy; Thermography

Keywords

ozone; ozone therapy; ultrasound; thermography

Outcome Measures

Primary Outcomes (1)

• EHP-30 - Endometriosis Health Profile Questionnaire

  The EHP-30 (Endometriosis Health Profile-30) is a disease-specific, patient-reported outcome measure designed to assess the health-related quality of life (HRQoL) in individuals with endometriosis on various aspects, including physical, emotional, and social well-being.

  EHP-30 will be applied at pre (baseline), through study completion, an average of 2 months.

Secondary Outcomes (1)

• Thermographic images

  Infra-red images will be captured at pre (baseline), through study completion, an average of 2 months.

Study Arms (1)

Ozone therapy on endometriosis

EXPERIMENTAL

The participants will undergo anamnesis, including clinical and epidemiological aspects for this research, including the capture of thermographic images. The participants will have previously undergone the transvaginal ultrasound examination; These participants will undergo 10 sessions, within the pre-established protocol with ozone. The selected participants will be allocated into two groups: Group A (ozone therapy) and Group B (control group - conventional treatment). Each group will consist of 20 participants. - Group A (Ozone Therapy): The participants in this group will undergo ozone therapy sessions, according to the established protocol, and will receive treatment in the pelvic cavity with an initial injection of ozonated water, followed by an injection of ozone gas. The application of ozone will be done according to standardized and referenced techniques. - Group B (Clinical treatment): The participants in this group will be monitored to compare the results.

Other: Ozone therapy

Interventions

Ozone therapy OTHER

The study also aims to analyze the efficacy of ozone therapy in participants affected by endometriosis, enriching the knowledge base in the field of women's health/gynecology. The expected results will contribute to improving current therapeutic approaches, informing clinical decisions and encouraging future research. Understanding the technique and its clinical applicability will help health professionals to offer personalized and effective treatments. In addition, the insights obtained can direct new investigations, such as the optimization of protocols or the exploration of innovative therapeutic combinations for even more satisfactory results. Based on the literature review and the biochemical properties of both techniques (ozone therapy and clinical approach), it may be possible that one of the approaches demonstrates a statistically superior advantage over the other. In addition, the research aims to investigate whether the quality of life of these participants will improve and i

Also known as: thermography, ultrasound

Ozone therapy on endometriosis

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with a clinical diagnosis of endometriosis (ultrasonography / transvaginal exam)
• years old

You may not qualify if:

• Pregnancy
• G6PD positive
• Addicted
• HIV and hepatitis positive
• Cancer
• Anticoagulant sensitive
• Endometrial surgery history

Sponsors & Collaborators

• Universidade Federal do Paraná: lead
• Philozon Geradores de Ozonio LTDA: collaborator

Study Sites (1)

Clínica Fernanda Ferraz - Fisioterapia Integrativa LTDA

Curitiba, Paraná, 80240-100, Brazil

Location

Related Publications (10)

• Pires MV, de Lima CJ, Carvalho HC, Moreira LH, Fernandes AB. Effectiveness of intravesical ozone in interstitial cystitis by the O'Leary-Sant symptom index. Int Urogynecol J. 2023 Jul;34(7):1437-1446. doi: 10.1007/s00192-022-05383-3. Epub 2022 Oct 15.

  PMID: 36242631 BACKGROUND

• Wei A, Feng H, Jia XM, Tang H, Liao YY, Li BR. Ozone therapy ameliorates inflammation and endometrial injury in rats with pelvic inflammatory disease. Biomed Pharmacother. 2018 Nov;107:1418-1425. doi: 10.1016/j.biopha.2018.07.137. Epub 2018 Sep 1.

  PMID: 30257358 BACKGROUND

• Merhi Z, Garg B, Moseley-LaRue R, Moseley AR, Smith AH, Zhang J. Ozone therapy: a potential therapeutic adjunct for improving female reproductive health. Med Gas Res. 2019 Apr-Jun;9(2):101-105. doi: 10.4103/2045-9912.260652.

  PMID: 31249259 BACKGROUND

• Gupta S, Goldberg JM, Aziz N, Goldberg E, Krajcir N, Agarwal A. Pathogenic mechanisms in endometriosis-associated infertility. Fertil Steril. 2008 Aug;90(2):247-57. doi: 10.1016/j.fertnstert.2008.02.093.

  PMID: 18672121 BACKGROUND

• Nisolle M, Donnez J. Peritoneal endometriosis, ovarian endometriosis, and adenomyotic nodules of the rectovaginal septum are three different entities. Fertil Steril. 1997 Oct;68(4):585-96. doi: 10.1016/s0015-0282(97)00191-x.

  PMID: 9341595 BACKGROUND

• Wright CI, Kroner CI, Draijer R. Non-invasive methods and stimuli for evaluating the skin's microcirculation. J Pharmacol Toxicol Methods. 2006 Jul-Aug;54(1):1-25. doi: 10.1016/j.vascn.2005.09.004. Epub 2005 Oct 25.

  PMID: 16256378 BACKGROUND

• Horne AW, Saunders PTK. SnapShot: Endometriosis. Cell. 2019 Dec 12;179(7):1677-1677.e1. doi: 10.1016/j.cell.2019.11.033. Epub 2019 Dec 12.

  PMID: 31951524 BACKGROUND

• Ahn SH, Singh V, Tayade C. Biomarkers in endometriosis: challenges and opportunities. Fertil Steril. 2017 Mar;107(3):523-532. doi: 10.1016/j.fertnstert.2017.01.009. Epub 2017 Feb 8.

  PMID: 28189296 BACKGROUND

• Smolarz B, Szyllo K, Romanowicz H. Endometriosis: Epidemiology, Classification, Pathogenesis, Treatment and Genetics (Review of Literature). Int J Mol Sci. 2021 Sep 29;22(19):10554. doi: 10.3390/ijms221910554.

  PMID: 34638893 BACKGROUND

• Saunders PTK, Horne AW. Endometriosis: Etiology, pathobiology, and therapeutic prospects. Cell. 2021 May 27;184(11):2807-2824. doi: 10.1016/j.cell.2021.04.041.

  PMID: 34048704 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Interventions

Thermography; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Thermometry; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Henrique Cunha Carvalho, PhD. Dr.

  UTFPR

  STUDY CHAIR

Central Study Contacts

Fernanda Luiza Ferraz, Physiotherapist / Therapist

CONTACT

55 41 99971-1737; fernandaferraz88@gmail.com

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: Evaluation of the effects of ozone therapy on endometriosis

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 25, 2025
• Study Start: June 18, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)