E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study is a randomized controlled, superiority trial comparing the number of MII oocytes following final follicle maturation with dual trigger (250 μg rhCG + 0.2mg Triptorelin) or GnRH-a trigger (0.2mg Triptorelin) in women undergoing elective fertility preservation. |
Este estudio es un estudio controlado aleatorizado de superioridad para comparar el número de ovocitos MII tras maduración folicular con doble descarga (250 μg rhCG + 0.2mg Triptorelin) o descarga con GnRH-a (0.2mg Triptorelin) en mujeres que realizan preservación de fertilidad social |
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E.1.1.1 | Medical condition in easily understood language |
To compare the number of mature oocytes (MII) retrieved after dual trigger and GnRH-a trigger in patients undergoing elective fertility preservation in a progestin-primed ovarian stimulation protocol. |
Comparar el número de ovocitos MII recuperados tras doble descarga y descarga simple con GnRH-a en pacientes que siguen preservación social en un protocolo de estimulación ovárica controlada |
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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 compare the number of mature oocytes (MII) retrieved after dual trigger and GnRH-a trigger in patients undergoing elective fertility preservation in a progestin-primed ovarian stimulation protocol. |
Comparar el número de ovocitos MII recuperados tras doble descarga y descarga simple con GnRH-a en pacientes que siguen preservación social en un protocolo de estimulación ovárica controlada |
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E.2.2 | Secondary objectives of the trial |
To compare the dual trigger and GnRH-a trigger regarding: 1. Total number of oocytes retrieved 2. Endocrine profile on the day after trigger (FSH, LH, Estradiol, progesterone) 3. Incidence of OHSS |
Comparar la doble descarga y la descarga con GnRH-a en relación a: Número total de ovocitos recuperados , perfil endocrinológico el día después de la descarga (FSH, LH, Estradiol, y Progesterona), y la indecencia de hiperestimulación ovárica |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• AFC < 20 • Anti-Mullerian hormone (AMH) ≤ 3ng/ml (AMH result of up to one year will be valid) • Age ≤ 40 years • BMI > 18 and < 30 kg/m2 • Willing to participate in the study |
• AFC < 20 • Anti-Mullerian hormone (AMH) ≤ 3ng/ml (AMH hasta un año antes) • Age ≤ 40 years • BMI > 18 and < 30 kg/m2 • Dispuesta a participar en el estudio |
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E.4 | Principal exclusion criteria |
• Medically indicated fertility preservation • AFC ≥ 20 • Polycystic ovarian syndrome (PCOS) according to the Rotterdam criteria • FSH ≥ 20 • History of untreated autoimmune, endocrine or metabolic disorders • Contraindication for hormonal treatment • Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment). |
• Indicación de preservación de fertilidad médica • AFC ≥ 20 • Síndrome de ovario poliquístico (Roterdam criteria) • FSH ≥ 20 • Historia de enfermedad autoinmune, endocrina o metabólica no controlada • Contraindicación de tratamiento hormonal
• Historia reciente de enfermedad severa que requiere tratamiento crónico que pudiera interferir con la seguridad del paciente o con el desarrollo del ensayo |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare the number of MII oocytes retrieved after final oocyte maturation with dual trigger and GnRH-a trigger in patients undergoing elective fertility preservation. |
Comparar el número de ovocitos MII recuperados tras doble descarga y descarga simple con GnRH-a en pacientes que siguen preservación social en un protocolo de estimulación ovárica controlada |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
About 34-36 hours thereafter oocyte pick-up will be performed. |
34-36 horas tras la descarga se realizará la punción folicular |
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E.5.2 | Secondary end point(s) |
1. Total number of oocytes retrieved 2. Endocrine profile on the day after trigger (FSH, LH, estradiol, progesterone) 3. Incidence of OHSS |
1. Número total de ovocitos recuperados 2. Perfil endocrino respecto (FSH, LH, estradiol, progesterona) 3. Incidencia de hiperestimulación ovárica |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Total number of oocytes retrieved:About 34-36 hours thereafter oocyte pick-up will be performed. Endocrine profile on the day after trigger Incidence of OHSS: Untul 7 days after oocyte pick-up |
Número de Ovocitos recuperados:34-36 horas tras la descarga se realizará la punción folicular Perfil endocrino: el día despues de la descarga Incidencia de hiperestimulación ovárica. Hasta 7 días tras la punción |
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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 | 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) | 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) | 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
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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 | |
E.8.9.1 | In the Member State concerned months | 19 |
E.8.9.1 | In the Member State concerned days | |