A clinical tryal of the utility of ozone in patients with implantation failures

Phase 1

• Conditions: Evaluate the action of ozone in the regulation, concentration and activation of uterine NK. Quantify the cytokines present in the uterine decidua pre and post ozone exposure in the uterus. Quantify the NK present in the uterine decidua pre and post ozone exposure in the uterus.; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2017-004669-28-ES
• Lead Sponsor: CENTRO GINECOLOGICO GINFER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

Patients who come to the reproduction unit who have previously undergone at least one cycle of IVF with their own oocytes or with donation of oocytes without achieving NRV and will make a deferred transfer, either from their own vitrified embryos or from donated embryos.
• Age between 18 and 40 years
• BMI (Body Mass Index) <18 or> 32 kg / m2
• Current serologies (performed less than 6 months in advance) with full analysis battery
• Immunological analysis prior to treatment, quantification of NK in blood, IL-12, IL-15 and IL-18

In the previous cycle / years, the patient suffered

• Repeated implementation failures (at least two transfers or failed transferences)
• Suspected uterine factor compromised
• Repeated miscarriages (at least two abortions)
• Biochemical pregnancies (at least two pregnancy tests between 10-20 mUI / ml in blood)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

genetic diseases

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified