Ozone Therapy for Women With Endometriosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ozone therapy.
- Who it may be relevant to
- Registry conditions: Endometriosis, Ozone Therapy, Thermography. Basic parameters: 25 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of the Effects of Ozone Therapy on Endometriosis
Overview
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.
Interventions
- Other 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 dir
Primary outcome measures
- EHP-30 - Endometriosis Health Profile Questionnaire [Time frame: EHP-30 will be applied at pre (baseline), through study completion, an average of 2 months.]
Secondary outcome measures (1)
- Thermographic images [Time frame: Infra-red images will be captured at pre (baseline), through study completion, an average of 2 months.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Clínica Fernanda Ferraz - Fisioterapia Integrativa LTDA — Curitiba
Publications
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07035522 · 7.499.295 · 86719325.4.0000.0177