E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type.
Less than 5 mm Endometrio despite 10 days with standard doses of estrogen therapy (6mg / 24h) |
-Mujeres en ciclo de recepción de ovocitos ajenos o de embriones (propios/ajenos), en tratamientos de tipo ciclo sustituido.
-Endometrio inferior a 5mm a pesar de 10 días con dosis estándar de estrogenoterapia (6mg/24h) |
|
E.1.1.1 | Medical condition in easily understood language |
Women in assisted reproduction treatment they receive own or donated embryos and presenting an endometrial development less than 5 mm despite having received treatment with estrogen therapy |
Mujeres en tratamiento de TRA que reciban embriones propios o donados que presenten un desarrollo endometrial inferior a 5 mm a pesar de haber recibido un tratamiento con estrogenoterapia |
|
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 |
knowing the clinical value of using the PRGF-Endoret therapy and endometrial level applications to improve endometrial thickness endometrial preparations for embryo transfer. |
conocer el valor clínico del uso de la Terapia PRGF-ENDORET y sus aplicaciones a nivel del endometrio para mejorar el grosor endometrial en las preparaciones endometriales para transferencia embrionaria. |
|
E.2.2 | Secondary objectives of the trial |
1. To evaluate the growth of endometrial thickness from the end of usual procedure stimulation until the end of use of the platelet plasma.
2. Analyze the impact of using platelet plasma on rates of implantation and pregnancy. |
1. Evaluar el crecimiento del grosor endometrial desde el final del procedimiento de estimulación habitual hasta el final del uso del plasma plaquetario.
2. Analizar el impacto del uso de plasma plaquetario sobre las tasas de implantación y gestación. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type.
- Less than 5mm despite 10 days with standard doses of estrogen therapy (6mg / 24h) Endometrio |
-Mujeres en ciclo de recepción de ovocitos ajenos o de embriones (propios/ajenos), en tratamientos de tipo ciclo sustituido.
-Endometrio inferior a 5mm a pesar de 10 días con dosis estándar de estrogenoterapia (6mg/24h) |
|
E.4 | Principal exclusion criteria |
- History of pelvic inflammatory disease
- Risk of infection |
-Antecedentes de Enfermedad inflamatoria pélvica
-Riesgo de infección |
|
E.5 End points |
E.5.1 | Primary end point(s) |
It is to find at least one difference 2mm increased endometrial wall |
Se quiere encontrar al menos, una diferencia de 2mm en el aumento de la pared endometrial |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
- Recruitment Period: June to October 2016
- Estimated to last patient treatment Date: January 2017
- End of the study Date: May 2017 |
-Periodo de reclutamiento: Junio a Octubre 2016
-Fecha estimada de fin de tratamiento del último paciente: Enero 2017
-Fecha fin del estudio: Mayo 2017 |
|
E.5.2 | Secondary end point(s) |
ASSESSMENT OF THE RATE OF IMPLEMENTATION
Apply a bilateral Student t test comparison of the average rate of implementation in IVI over the past 4 years.
ASSESSMENT OF PREGNANCY RATE
Similarly, we apply a test of Fisher on a 2x2 design based on the results of gestation. It will be used as contrast group data IVI Bilbao in the last 4 years. |
VALORACIÓN DE LA TASA DE IMPLANCIÓN
Aplicaremos una prueba t-Student bilateral de comparación sobre la tasa media de implantación en IVI durante los 4 últimos años.
VALORACIÓN DE LA TASA DE GESTACIÓN
De forma análoga, aplicaremos una prueba de Fisher sobre un diseño 2x2 basado en los resultados de gestación. Se utilizará como grupo de contraste los datos de IVI Bilbao en los últimos 4 años. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Recruitment Period: June to October 2016
- Estimated to last patient treatment Date: January 2017
- End of the study Date: May 2017 |
-Periodo de reclutamiento: Junio a Octubre 2016
-Fecha estimada de fin de tratamiento del último paciente: Enero 2017
-Fecha fin del estudio: Mayo 2017 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
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) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Prospectivo observacional |
prospective observational |
|
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 | Yes |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |