E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Estimulación ovárica controlada para reproducción asistida |
Estimulación ovárica controlada para reproducción asistida |
|
E.1.1.1 | Medical condition in easily understood language |
Infertilidad en mujeres de edad reproductiva avanzada |
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E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003539 |
E.1.2 | Term | Assisted fertilisation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
Determinar la eficacia de la administración de lutropina alfa al objetivar un folículo ?14 mm Ø, frente a la no administración de la misma, en mujeres con edad reproductiva avanzada incluidas en un protocolo de estimulación ovárica de supresión con un antagonista de la GnRH para ICSI-TE, en cuanto al número total de ovocitos y de metafase II recuperados. |
|
E.2.2 | Secondary objectives of the trial |
Verificar la seguridad de añadir lutropina alfa al tratamiento con r-hFSH en ésta población, atendiendo a la incidencia del síndrome de hiperestimulación ovárica (SHO), acontecimientos adversos y signos/síntomas de irritación local. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Mujeres estériles, en edad fértil y que desean quedarse embarazadas. 2. Esterilidad que justifica el tratamiento mediante ICSI-TE. 3. Edad reproductiva avanzada, definida como una edad igual o superior a 35 años. 4. Ciclos menstruales espontáneos regulares de 25-35 días. 5. Mujeres incluidas en un protocolo con antagonista de la GnRH. |
|
E.4 | Principal exclusion criteria |
1. Historia de HIV, HBV/HCV. 2. Presencia de enfermedad sistémica de relevancia clínica, tumor hipotalámico o hipofisario, cáncer ovárico, uterino o de mama, anomalía hormonal o médica, bioquímica o hematológica, que a juicio del investigador pueda interferir con el tratamiento con gonadotrofinas. 3. Más de 3 ciclos previos de reproducción asistida. 4. Disponer de embriones congelados de ciclos previos con la misma jeringa. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Variable principal: número total de ovocitos y en metafase II y la razón resultante de ambos. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Los ovocitos se recuperan a las 34-38h tras la administración de la rhCG |
Los ovocitos se recuperan a las 34-38h tras la administración de la rhCG |
|
E.5.2 | Secondary end point(s) |
Ovocitos fertilizados, número de embriones y calidad, tasa de implantación |
Ovocitos fertilizados, número de embriones y calidad, tasa de implantación |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Tras fertilizacion in vitro |
|
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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Information not present in EudraCT |
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
|
Última visita de la última paciente. |
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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 | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |