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EndometriosisNCT07035522

Ozone Therapy for Women With Endometriosis

A study testing Ozone therapy in people with Endometriosis and Ozone Therapy, run by Universidade Federal do Paraná at 1 site in Brazil.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 25 to 45 years, women only
Conditions the study is for
Endometriosis, Ozone Therapy, Thermography
What is being tested?
Ozone therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
18 Jun 2025to 20 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fernanda Luiza Ferraz, Physiotherapist / Therapist contact

55 41 99971-1737

fernandaferraz88@gmail.com

Brazil1 site
  • Clínica Fernanda Ferraz - Fisioterapia Integrativa LTDA

    Curitiba, Paraná, 80240-100

    Fernanda Luiza Ferraz, Physiotherapist / Therapist, 55 41 999711737, fernandaferraz88@gmail.com

Other trials in Brazil

About this study

Official title: Evaluation of the Effects of Ozone Therapy on Endometriosis

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.

Read the 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.

Being tested
Ozone therapy
Keywords
ozone, ozone therapy, ultrasound, thermography
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ozone therapyOther

    Also called thermography, ultrasound

    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

Study groups in NCT07035522
Study groupRoleWhat they receive
Ozone therapy on endometriosisExperimentalThe 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.
Receives: Other: Ozone therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. Thermographic images

    Thermography, a non-invasive imaging technique that detects infrared radiation to map skin surface temperature, will be applied as a tool to assess the physiological response to ozone therapy in endometriosis. Ozone therapy, known for its anti-inflammatory and analgesic properties, may influence local blood flow and immune activity. Thermographic imaging allows visualization of these changes by capturing temperature variations in the abdominal or pelvic regions before (baseline), during (4 and 7th session) and after treatment (10th session). In endometriosis, affected areas often exhibit thermal asymmetry or increased heat due to inflammation. Post-ozone therapy, thermography can reveal reductions in localized hyperthermia, suggesting decreased inflammation and improved circulation. This method provides a visual, quantifiable means to monitor treatment response over time, offering a complementary assessment tool alongside symptom tracking.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2025
  2. Study start18 Jun 2025 (estimated)
  3. Primary completion20 Dec 2025 (estimated)
  4. Study completion20 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07035522
Sponsor's protocol ID
7.499.295
Other IDs
86719325.4.0000.0177
Status last verified
Jun 2025
First submitted
2 Jun 2025
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Ethical or Consent Restrictions: Participants may not have given explicit consent for their data to be shared beyond the original study. Legal or Institutional Policies: Data sharing may be restricted by Brazillian laws.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 28189296
  • 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.

    PubMed 34638893
  • 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.

    PubMed 34048704

Questions about this trial

What is this clinical trial studying?

A study testing Ozone therapy in people with Endometriosis and Ozone Therapy, run by Universidade Federal do Paraná at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fernanda Luiza Ferraz, Physiotherapist / Therapist (55 41 99971-1737, fernandaferraz88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EHP-30 - Endometriosis Health Profile Questionnaire (time frame: EHP-30 will be applied at pre (baseline), through study completion, an average of 2 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07035522, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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