E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Estimulación del desarrollo de multiples folículos en pacientes femeninas que estan en tratamiento de reproducción asistida.
Stimulation of multifollicular develoment in patients undergoing assisted reproductive treatment |
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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 |
Demostrar la equivalencia entre AFOLIA y Gonal-f®.
To show equivalence between AFOLIA and Gonal-f® |
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E.2.2 | Secondary objectives of the trial |
Comparar los resultados relacionados con el tratamiento y la seguridad entre AFOLIA y Gonal-f®.
To compare therapy related outcomes and safety between AFOLIA and Gonal-f® |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Tener entre 20 y 38 de edad con ciclos normales de menstruación de 25 a 35 días - Primero o segundo ciclo en la presente serie de TRA - IMC >= 18 <= 30 kg/m2 - FSH basal < 10 UI/l (días 2 al 5 del ciclo) - Concentración de E2 < 50pg/ml (< 0.18 nmol/l) el día en que se administra la FSH - Recuento del folículo antral (RFA) >= 10 to <= 25 folículos (suma de ambos ovarios) - Infertilidad debida a cualquiera de los siguientes factores: factor tubárico, endometriosis leve (fase 1 a 2 de la ASRM), factor masculino, infertilidad no explicada - Presencia de ambos ovarios y cavidad uterina normal (confirmados por ultrasonido transvaginal dentro de 6 meses antes de la aleatorización) - Disposición de participar en el estudio y de cumplir con el protocolo del estudio - Consentimiento informado
- Age between 20 and 38 years with regular menstrual cycles of 25-35 days - First or second cycle in the present series of ART - BMI >= 18 <= 30 kg/m2 - Basal FSH < 10 IU/L (cycle day 2-5) - E2 levels < 50pg/mL (< 0.18 nmol/L) at the day of FSH administration - Antral follicle count (AFC) >= 10 to <= 25 follicles (sum of both ovaries) - Infertility due to any of the following factors: tubal factor, mild endometriosis (ASRM stage 1-2), male factor, unexplained infertility - Presence of both ovaries and normal uterine cavity (confirmed by transvaginal ultrasound within 6 months before randomisation) - Willingness to participate in the study and to comply with the study protocol - Informed consent |
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E.4 | Principal exclusion criteria |
- Presencia de un embarazo - Antecedentes de >= 2 ciclos de TRA subsiguientes (FIV y/o IICE) antes del ciclo del estudio sin embarazo clínico - Presencia de una enfermedad sistémica clínicamente importante - Presencia de una enfermedad cardiovascular, hepática, renal o pulmonar crónica - Presencia de un trastorno endócrino no controlado - Antecedentes o presencia de un fuerte síndrome de hiperestimulación ovárica - Presencia de ovarios poliquísticos (OPQ) - Presencia de endometriosis grave (fase 3 ó 4 de la ASRM) e hidrosalpinge - Neoplasia - Sangrado anormal de origen no determinado - Antecedentes de mala reacción al tratamiento con gonadotrofina (definido como menos de 5 ovocitos sacados en un intento anterior) - Infertilidad masculina sin espermatozoides móviles en el eyaculado, necesitando la aspiración de espermatozoides del epidídimo (MESA/TESE/TESA) - Anormalidad endócrina como elevaciones en la concentración de la TSH o prolactina fuera del intervalo de referencia si son clínicamente importantes en la selección - Cualquier tratamiento hormonal dentro de 1 mes antes de comenzar el tratamiento con la FSH (a excepción de levotiroxina) - Antecedentes de drogadicción, alcoholismo o tabaquismo (> 10 cigarros/día) en los últimos 12 meses - Administración de otros productos bajo investigación en el último mes - Resultados clínicamente anormales en la 1ª consulta - PGS/PGD/PBB planificados o incubación asistida - Participación concomitante en otro protocolo de estudio
- Presence of pregnancy - History of >= 2 succeeding ART cycles (IVF and/or ICSI) before the study cycle without clinical pregnancy - Presence of clinically significant systemic disease - Presence of chronic cardiovascular, hepatic, renal or pulmonary disease - Presence of uncontrolled endocrine disorder - Previous history or presence of severe ovarian hyperstimulation syndrome - Presence of polycystic ovaries (PCO) - Presence of severe endometriosis (ASRM stage 3 or stage 4) and hydrosalpinx - Neoplasia - Abnormal bleeding of undetermined origin - History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt) - Male infertility without mobile spermatozoa in the ejaculate, that need testicular of epididymal sperm retrieval (MESA/TESE/TESA) - Endocrine abnormality such as TSH or prolactin level elevations outside the reference range if clinically relevant at screening - Any hormonal treatment within 1 month before the start of the FSH treatment (with the exception of levothyroxin) - History of drug, nicotine or alcohol abuse within the last 12 months (> 10 cigarettes/day) - Administration of other investigational products within the last month - Clinically abnormal findings at Visit 1 - Planned PGS/PGD/PBB or assisted hatching - Concomitant participation in an other study protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparar el número de ovocitos aspirados de pacientes sometidas al tratamiento de TRA con AFOLIA frente a Gonal-f®.
To compare the number of oocytes retrieved from patients undergoing ART treatment with AFOLIA versus Gonal-f® |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
E.8.1.3 | Single blind | Yes |
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.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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El final del ensayo en un Estado Miembro (EM) de la UE se define como el momento en que se considera que suficientes sujetos han sido reclutados y terminaron el ensayo como se indica en la solicitud de reglamentación (aplicación de Ensayos Clínicos (CTA)) y en la solicitud ética del EM. Un bajo índice de reclutamiento (reclutamiento inferior al número previsto en la CTA) por un EM no es una razón para la terminación prematura, sino se considera como una conclusión normal al ensayo en dicho EM. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |