E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Oocyte donation |
Donación de ovocitos |
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E.1.1.1 | Medical condition in easily understood language |
Oocyte donation |
Donación de ovocitos |
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E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
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 study the efficiency of the use of a single injection of CFA for ovarian stimulation, initiating administration late and without further contribution of FSH activity after the 7th day of stimulation compared to conventional EOC using CFA (administration of the drug 5 days after cesar hormonal contraceptive and supplementation with FSH daily administration from the 8th day of stimulation). |
Estudiar la eficiencia de la utilización de una inyección única de CFA para la estimulación ovárica iniciando la administración de forma tardía y sin más aporte de actividad de FSH tras el 7º día de estimulación comparado con la EOC convencional utilizando CFA (administración del fármaco 5 días después de cesar el anticonceptivo hormonal y suplementación con FSH de administración diaria a partir del 8º día de estimulación). |
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E.2.2 | Secondary objectives of the trial |
• Evaluate the duration of the treatment of the different protocols • Evaluate the total cost of treatment • Evaluate the economic cost by number of oocyte obtained. |
• Evaluar la duración del tratamiento de los distintos protocolos • Evaluar el coste total del tratamiento • Evaluar el coste económico por numero de ovocito obtenido. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. To be considered fit to enter the Bernabeu Institute oocyte donation program (Annex I) 2. Age between 18 and 32 years 3. BMI> 18 and <30 4. Antral follicle count> 12 (adding both ovaries) 5. Presence of both ovaries 6. Ability to participate and comply with the study protocol 7. Having given written consent 8. Not having received treatment with ovulation stimulators in the 3 months prior to the start of the stimulation. |
1. Ser considerada apta para entrar en el programa de donación de ovocitos del Instituto Bernabeu (anexo I) 2. Edad entre 18 y 32 años 3. IMC >18 y <30 4. Recuento de folículos antrales >12 (sumando ambos ovarios) 5. Presencia de ambos ovarios 6. Capacidad para participar y cumplir con el protocolo del estudio 7. Haber dado su consentimiento por escrito 8. No haber recibido tratamiento con estimuladores de la ovulación en los 3 meses previos al inicio de la estimulación. |
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E.4 | Principal exclusion criteria |
1. Diagnosis of endometriosis at any stage 2. AFC> 20 3. SOP 4. Concurrent participation in another study |
1. Diagnóstico de endometriosis en cualquier estadio 2. AFC >20 3. SOP 4. Participación concurrente en otro estudio |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of oocytes |
Número de ovocitos |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the patient study |
Al final del estudio de cada paciente |
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E.5.2 | Secondary end point(s) |
• Number of Cumulus-Ovocyte Complex obtained • Duration of stimulation (days) • Total cost of treatment • Cost of oocyte treatment collected in metaphase stage II |
• Numero de Complejo Cúmulo-Ovocito obtenidos • Duración de la estimulación (días) • Coste total del tratamiento • Coste del tratamiento por ovocito recogidos en estadio de metafase II |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of the patient study |
Al final del estudio de cada paciente |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
The efficacy of the treatment administered at the usual time of clinical practice will be compared with the efficacy of administering it at another time and reducing the dose. |
Se comparará la eficacia del tratamiento administrado de la forma y en el momento habitual de la práctica clínica con la eficacia de administrarlo en otro momento y solamente una única dosis. |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 |
Una sola inyección de 150 microgramos del tratamiento de forma tardía |
A single injection of 150 micrograms late treatment |
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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.8.5 | 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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |