Ozone Therapy for Women With Endometriosis

NCT ID: NCT07035522

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-18
• Study Completion Date: 2025-12-20

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.

Detailed Description

Endometriosis is a chronic gynecological condition characterized by the abnormal presence of endometrial glands and stroma outside the uterus, accompanied by chronic inflammation. It is found mainly in girls and women of reproductive age, and according to data from the World Health Organization, it occurs in approximately 10% of women of reproductive age (190 million) worldwide. Effective management of endometriosis requires rapid diagnosis to allow early multidisciplinary intervention that aligns with the patient's needs and priorities. The etiopathogenesis is not yet well established, but evidence indicates that the combination of genetic, hormonal and immunological factors may contribute to the formation and development of ectopic foci of endometriosis. The clinical picture is quite variable. It may be asymptomatic, refer only to infertility or have symptoms such as severe dysmenorrhea, deep dyspareunia, chronic pelvic pain, ovulatory pain, urinary or perimenstrual evacuation symptoms and chronic fatigue. Uncertainty and delays in diagnosis contribute to disturbances in the emotional system, impacting on quality of life. The objective of this research project is to evaluate the effectiveness of ozone therapy and the assessment by means of diagnostic imaging examinations using transvaginal ultrasound and infrared thermography, before, during and after the intervention, aiming at a comparative investigation of possible evidence of the evolution of patients diagnosed with endometriosis who did not respond to conventional treatments, as well as to apply a consolidated questionnaire that assesses changes in the quality of life of the participants after the intervention. This study is part of an experimental research project and will be carried out in a private clinic, Clínica Fernanda Ferraz - Fisioterapia Integrativa LTDA. The clinic is located at Travessa João Turin, 37, room 603 - Água Verde, Curitiba-PR. The target population of this study will be composed of women between the ages of 25 and 45, with a diagnosis based on a report of endometriosis (all stages will be treated). A convenience sample will be used, recruited through advertisements on social networks. A total of 40 participants will be selected for the study, divided equally into two groups: Group A (ozone therapy) and Group B (control group - conventional clinical treatment). This study will contribute to a deeper understanding of the effects of ozone therapy on endometriosis. It is expected that a statistically significant analysis will be observed that will highlight important differences in imaging in transvaginal ultrasound and thermographic examinations, as well as in symptoms and quality of life. Based on the literature review and the biochemical properties of both techniques (ozone therapy and clinical approach), it is likely that one of the approaches will demonstrate a statistically superior advantage over the other. In addition, the research aims to investigate whether the quality of life of the participants will improve, and in some cases, with potential positive results on infertility.

Conditions

Endometriosis; Ozone Therapy; Thermography

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ozone therapy on endometriosis

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.

Group Type: EXPERIMENTAL

Ozone therapy

Intervention Type: 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

Interventions

Ozone therapy

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

Intervention Type: OTHER

Other Intervention Names

thermography; ultrasound

Eligibility Criteria

Inclusion Criteria

• Women with a clinical diagnosis of endometriosis (ultrasonography / transvaginal exam)
• 25-45 years old

Exclusion Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Philozon Geradores de Ozonio LTDA

INDUSTRY

Sponsor Role: collaborator

Universidade Federal do Paraná

OTHER

Sponsor Role: lead

Responsible Party

Henrique Cunha Carvalho

Evaluation of the effects of ozone therapy on endometriosis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henrique Cunha Carvalho, PhD. Dr.

Role: STUDY_CHAIR

UTFPR

Locations

Clínica Fernanda Ferraz - Fisioterapia Integrativa LTDA

Curitiba, Paraná, Brazil

Countries

Brazil

Central Contacts

Fernanda Luiza Ferraz, Physiotherapist / Therapist

Role: CONTACT

fernandaferraz88@gmail.com

55 41 99971-1737

Facility Contacts

Fernanda Luiza Ferraz, Physiotherapist / Therapist

Role: primary

fernandaferraz88@gmail.com

55 41 999711737

References

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Reference Type: BACKGROUND

PMID: 36242631 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30257358 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 31249259 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18672121 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9341595 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 16256378 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31951524 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28189296 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34638893 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34048704 (View on PubMed)

Other Identifiers

86719325.4.0000.0177

Identifier Type: OTHER

Identifier Source: secondary_id

7.499.295

Identifier Type: -

Identifier Source: org_study_id