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.
Conditions
Interventions
Product Name: OZONE
Product Code: OZONE
Pharmaceutical Form: Medicinal gas, compressed
INN or Proposed INN: gas medical ozone
CAS Number
Sponsors
CENTRO GINECOLOGICO GINFER
Eligibility
Sex/Gender
All
Inclusion criteria
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) 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
Exclusion criteria: genetic diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to obtain a higher implantation rate through the modulating action of ozone in the immune system in patients with implementation failures and repeated abortions; Secondary Objective: 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. ; Primary end point(s): The success of this clinical trial achieved high demand expectations, due to the fact that almost 19% of the Spanish population of reproductive age have infertility problems, with a significant percentage of implantation failures. In addition, according to experts, the problems of reproduction increase. Commercially, the interest lies in the possibility of offering a new service within the field of the assisted image, and with it, a claim for patients and a competitive advantage that is very important and that offers a place to the generation of new services clinics associated with reproduction with an innovative tool totally safe and without side effects. ;Timepoint(s) of evaluation of this end point: during two years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The same that primary end points;Timepoint(s) of evaluation of this end point: the same that primary end points | — |
Countries
Spain
Contacts
Public ContactANA FERNANDEZ SAINZ
GINFER
Outcome results
None listed