E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
Evaluar la acción del ozono en la regulación, concentración y activación de las NK uterinas. Cuantificar las citoquinas presentes en la decidua uterina pre y post exposición de ozono en el útero. Cuantificar las NK presentes en la decidua uterina pre y post exposición de ozono en el útero. Establecer una relación entre las citoquinas presentes y los efectos moduladores y reguladores que producen sobre las NK uterinas. |
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E.1.1.1 | Medical condition in easily understood language |
Evaluate the action of ozone gas in the humna endometrium |
Evaluar la acción del ozono en el endometrio humano |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
El objetivo de este ensayo es conseguir una mayor tasa de implantación mediante la acción moduladora del ozono en el sistema inmune en pacientes con fallos de implantación y abortos repetidos |
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E.2.2 | Secondary objectives of the trial |
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. |
Evaluar la acción del ozono en la regulación, concentración y activación de las NK uterinas. Cuantificar las citoquinas presentes en la decidua uterina pre y post exposición de ozono en el útero. Cuantificar las NK presentes en la decidua uterina pre y post exposición de ozono en el útero. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
Pacientes que acuden a la unidad de reproducción que previamente se han sometido a al menos a un ciclo de FIV con ovocitos propios o con donación de ovocitos sin lograr RNV y van a realizar una transferencia en diferido, bien de embriones vitrificados propios o de embriones donados. • Edad comprendida entre 18 y 40 años • IMC (Índice de Masa Corporal) <18 o >32 kg/m2 • Serologías vigentes (realizadas con menos de 6 meses de antelación) con batería de análisis completa • Analítica inmunológica previa al tratamiento, cuantificación de NK en sangre, IL-12, IL-15 e IL-18
En el ciclo/os anteriores la paciente ha sufrido
• Fallos repetidos de implantación (al menos dos transferencias o criotransferencias fallidas) • Sospecha de factor uterino comprometido • Abortos repetidos (al menos dos abortos) • Embarazos bioquímicos (al menos dos pruebas de embarazo entre 10-20 mUI/ml en sangre ) |
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E.4 | Principal exclusion criteria |
genetic diseases |
Problemas genéticos previos |
|
E.5 End points |
E.5.1 | 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. |
El éxito del presente ensayo clínico permitirá generar unas elevadas expectativas de demanda, debido a que casi un 19% de la población española en edad reproductiva tiene problemas de infertilidad, con un importante porcentaje de fallos de implantación. Además, según los expertos, los problemas de reproducción van en aumento. Comercialmente, el interés radica en la posibilidad de ofrecer un nuevo servicio dentro del campo de la reproducción asistida, y con ello, un reclamo para los potenciales pacientes y una ventaja competitiva muy importante ya que dará lugar a la generación de nuevos servicios clínicos asociados a la reproducción con una innovadora herramienta totalmente segura y sin efectos secundarios. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
during two years |
Alrededor de dos años |
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E.5.2 | Secondary end point(s) |
The same that primary end points |
Los mismos puntos que los puntos iniciales |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
the same that primary end points |
Los mismos puntos que los puntos iniciales |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last visit of the pacient will be a embrions transfer |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |