E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study is proposed to determine the level of compliance and pharmacoeconomic impact of three protocols for controlled ovarian stimulation in women participating in oocyte donation program |
El estudio está planteado para determinar el grado de cumplimiento y el impacto fármaco-económico de tres protocolos de estimulación ovárica controlada en mujeres que participan en un programa de donación de ovocitos |
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E.1.1.1 | Medical condition in easily understood language |
It is intended to determine the effectiveness, in terms of egg quality, of a long-term gonadotropin versus a conventional dose daily administration of gonadotropin |
Se pretende determinar la eficacia, en términos de calidad ovocitaria, de una gonadotropina de larga duración frente a una pauta convencional con gonadotropinas de administración diaria |
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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 |
Non-inferiority study of corifollitropin alfa regarding a conventional ovarian stimulation protocol with recombinant FSH and / or HP-hMG compared to the number of oocytes retrieved and the number of metaphase II oocytes |
Estudio de no-inferioridad de la corifolitropina alfa respecto a un protocolo de estimulación ovárica convencional con FSH recombinante y/o HP-hMG en relación al número de ovocitos recuperados y a la cantidad de ovocitos metafase II |
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E.2.2 | Secondary objectives of the trial |
- Comparative analysis of the fertilization and implantation rates
- Comparative analysis of the drop-out rate and cycle cancellation rate
- Analysis of the pharmacoeconomic impact related to the administration of a long term gonadotropin (Corifollitropin alfa) versus two daily administration of gonadotropins (FSH and recombinant HP-hMG).
- Assessment of oocyte quality parameters through the following analysis:
- Analysis of the hormonal profile in serum and follicular fluid
- Analysis of apoptosis rate in cumulus cells |
- Análisis comparativo de las tasas de fecundación e implantación
- Análisis comparativo de la tasa de abandono y de la tasa de cancelación de ciclo
- Análisis del impacto fármcao-económico derivado de la administración de una gonadotropina de larga duración (corifolitropina alfa) frente a dos gonadotropinas de administración diaria (FSH recombinante y HP-hMG)
- Evaluación de parámetros de calidad ovocitaria a través de los siguientes análisis:
- Análisis del perfil hormonal en suero y líquido folicular
- Análisis de las tasas de apoptosis en células del cúmulo ovocitario |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women aged 18-35 years who meet the entry criteria for the IVI Donor Program and will be receiving stimulation with gonadotropins.
- Weight <60 kg
- Women with at least 6 antral follicles per ovary
- Will to fit the protocol during the study period
- Woman who gives written consent to participate in Test |
- Mujeres entre 18-35 años que cumplan con los criterios de entrada en el Programa de Donantes de IVI y vayan a recibir estimulación con gonadotropinas.
- Peso <60 kilogramos
- Mujer con al menos 6 folículos antrales por ovario
- Voluntad de ajustarse al protocolo durante el periodo de estudio
- Mujer que otorgue por escrito su consentimiento para participar en el Ensayo |
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E.4 | Principal exclusion criteria |
- Woman with a basal antral follicle count above 20 or below 6
- Women with comorbidities, in the judgment of the investigator, that may interfere with the treatment of ovarian stimulation |
-Mujer con un recuento basal de folículos antrales superior a 20 ó inferior a 6
- Mujeres con patologías asociadas que, a juicio del investigador, puedan interferir en el tratamiento de estimulación ovárica |
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E.5 End points |
E.5.1 | Primary end point(s) |
Degree of oocyte quality, defined as the number of metaphase II oocytes and the percentage of apoptosis in cumulus cells obtained at each stimulation protocols |
Grado de calidad ovocitaria, definido como el número de ovocitos metafase II y el porcentaje de apoptosis en células del cúmulo obtenidos en cada uno de los protocolos de estimulación. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Length of stimulation (days)
- Total dose of gonadotropins (IU)
- Levels of FSH (IU)
- Levels of estradiol (pg / ml)
- Levels of progesterone (ng / ml)
- Fertilization rate
- Number of embryos transferred and cryopreserved
- Pregnancy rate
- Implantation rate
- Abortion rate
- Cancellation rate per cycle initiated
- Ovarian hyperstimulation síndrome rate
- Count of adverse events |
- duración del tratamiento (días de estimulación)
- dosis total de gonadotropinas
- niveles de FSH (UI)
- niveles de estradiol (pg/ml)
- niveles de progesterona (ng/ml)
- tasa de fecundación
- número de embriones transferidos y criopreservados
- tasa de gestación
- tasa de implantación
- tasa de aborto
- tasa de cancelación por ciclo iniciado
- tasa de síndrome de hiper-estimulación ovárica
- recuento acontecimientos adversos |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | Yes |
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) | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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 | 3 |
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 | 4 |
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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The test will be terminated when each patient has completed the follow-up period, or by discontinuation by:
- Completion of the assay protocol
- Loss of tracking (inability to contact the patient)
- Decision of the patient (specify reason)
- Decision of the researcher (gynecologist or nurse)
- Preventing adverse reaction by continuing the patient in the trial
-Death |
El ensayo se dará por finalizado cuando cada paciente haya concluido el periodo de seguimiento, o bien por interrupción del mismo por:
- Finalización del ensayo por protocolo
- Pérdida de seguimiento (incapacidad de contactar con la paciente)
- Decisión de la paciente (especificar el motivo)
- Decisión del investigador (ginecólogo o personal de enfermería)
- Por reacción adversa que impida la continuación de la paciente en el ensayo
-Fallecimiento |
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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 | |
E.8.9.1 | In the Member State concerned days | |