E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Women who meet the criteria for infertility Bologna |
Mujeres que cumplen con el criterio de Bolonia de infertilidad. |
|
E.1.1.1 | Medical condition in easily understood language |
Women with low response of your ovaries. |
Mujeres con baja respuesta de su ovarios. |
|
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 |
To investigate the efficiency of OVARTICA STIMULATION CONTROLLED by alpha Corifollitropin, in patients with expected or poor ovarian response undergoing IVF / ICSI. |
Investigar la eficiencia de la EESTIMULACION OVARTICA CONTROLADA mediante corifolitropina alfa, en pacientes con esperada o pobre respuesta ovárica que se someten a FIV/ICSI mediante |
|
E.2.2 | Secondary objectives of the trial |
To investigate the efficiency, effectiveness and safety of the EOC by CFA in patients with expected or poor ovarian response undergoing IVF / ICSI. |
Investigar la eficiencia, efectividad y seguridad de la EOC mediante CFA, en pacientes con esperada o pobre respuesta ovárica que se someten a FIV/ICSI. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients ? 18 years of age. - Patients who have previously signed consent to participate in this study. - Quen pacietnes submit one of the following factors: 1. Have a history of medical or surgical treatment as a risk factor for POR. 2. Have had a poor ovarian response in response to the EOC (previous cycle after conventional stimulation with ? 3 oocytes) 3. Are poor ovarian response wait to have abnormal ovarian reserve test: AMH <1.1 ng / ml (<8 pM) or RFA <7 |
Pacientes ? 18 años de edad. Pacientes que hayan firmado previamente el consentimiento para participar en este estudio. Pacientes que presenten uno de los siguientes factores: 1. Tengan antecedente de tratamiento quirúrgico o médico como factor de riesgo de POR. 2. Hayan tenido una pobre respuesta ovárica en respuesta a la EOC (Ciclo previo, tras estimulación convencional, con ? 3 ovocitos) 3. Se espere una pobre respuesta ovárica por tener test de reserva ovárica anormales: AMH < 1,1 ng/ml (< 8 pM) ó RFA < 7. |
|
E.4 | Principal exclusion criteria |
- Anovulation. - Patient with tubal factor, untreated - Patient with uterine pathology, untreated. - Couples with severe male factor, fresh count <5 million / ml, and azoospermia in which sperm are used of the patient, epididymal or testicular. - Patients with BMI> 28. |
- Anovulación. - Paciente con factor tubárico, no tratado - Paciente con patología uterina, no tratada. - Parejas con factor masculino severo, recuento en fresco < 5 mill/ml, y con azoospermia en la que se utilicen espermatozoides del paciente, epididimarios o testiculares. - Pacientes con IMC > 28. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Tasa de gestación evolutiva /ciclo Número de ovocitos metafase II/paciente |
Evolutionary pregnancy rate / cycle Number of metaphase II oocytes / patient |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
During the pregnancy. |
Durante la gestación. |
|
E.5.2 | Secondary end point(s) |
Rating patient characteristics: age, BMI. ? adverse effects rating ELONVA 150. ? Assessment of the response to the EOC by: - Cancellation fee - Total dose of gonadotropins used. - Required days of stimulation. - Serum oestradiol levels on the day of hCG. - Number of follicles punctured. - Number of oocytes obtained. - Fertilization rate. - Number of viable embryos at 48h after fertilization. Embryo quality. - Number of embryos transferred - Number of frozen embryos. - Implantation rate. - Pregnancy rate / cycle started - Pregnancy rate / oocyte collection - Pregnancy rate / embryo transfer - Abortion rate
? Rating BY predictors markers before stimulation. Relating AMH values ??and RFA with no oocytes retrieved and pregnancy rate evolution. ? Cost-effectiveness evaluation to check for economic differences between the two branches in relation to the number of metaphase II oocytes per patient and evolutionary pregnancy rate per cycle |
? Valoración de las características de las pacientes: edad, IMC. ? Valoración de efectos adversos del ELONVA 150. ? Valoración de la respuesta a la EOC mediante: - tasa de cancelación - dosis total de gonadotropinas empleada. - días necesarios de estimulación. - niveles séricos de estradiol en día de hCG. - número de folículos puncionados. - número de ovocitos obtenidos. - tasa de fecundación. - número de embriones viables a las 48h de la fecundación. Calidad embrionaria. - número de embriones transferidos - número de embriones congelados. - tasa de implantación. - tasa de gestación/ciclo iniciado - tasa de gestación/captación ovocitaria - tasa de gestación/transferencia embrionaria - tasa de aborto
? Valoración de marcadores predictores de POR previos a la estimulación. Relacionando valores de AMH y RFA con nº ovocitos obtenidos y tasa de gestación evolutiva. ? Valoración de coste-efectividad para comprobar si existen diferencias económicas entre ambas ramas en relación al nºde ovocitos metafase II por paciente y a la tasa de gestación evolutiva por ciclo. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
During the pregnancy. |
Durante la gestación. |
|
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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
|
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | |