E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with predictive indicators of low ovarian response (according to Poseidon criteria) and who undergo double ovarian stimulation (Dual Stim). |
Pacientes con indicadores predictivos de baja respuesta ovárica (según criterios Poseidon) y que realizan estimulación ovárica doble (Dual Stim). |
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E.1.1.1 | Medical condition in easily understood language |
Baja respuesta ovárica durante el tratamiento de FIV. |
Baja respuesta ovárica durante el tratamiento de FIV. |
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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 efficacy of Double Trigger (Ovitrelle® + Decapeptyl®) vs. hCG-rec (Ovitrelle®) or aGnRG (Decapeptyl®) isolated in terms of number of total and mature oocytes obtained in the second cycle of a Dual Stim sequence. |
Comparar la eficacia de Doble Trigger (Ovitrelle® + Decapeptyl®) vs. hCG-rec (Ovitrelle®) o aGnRG (Decapeptyl®) aislados en términos de número de ovocitos totales y maduros obtenidos en el segundo ciclo de una secuencia Dual Stim. |
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E.2.2 | Secondary objectives of the trial |
- To analyze the number of total and mature oocytes obtained in the 1st and 2nd cycle of the Dual Stim sequence. - To analyze the number of blastocysts per patient. - To analyze the number of blastocysts vitrified per patient after the 1st and 2nd stimulation. - To analyze the implantation rate, clinical pregnancy, clinical miscarriage and biochemical miscarriage. - To analyze the newborn rate. |
- Analizar el número de ovocitos totales y MII obtenidos en el 1º y 2º ciclo de la secuencia Dual Stim - Analizar el número de blastocistos por paciente - Analizar el número de blastocistos vitrificados por paciente tras la 1ª y 2ª estimulación - Analizar la tasa de implantación, embarazo clínico, aborto clínico y aborto bioquímico. - Analizar la tasa de recién nacido |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age: less than or equal to 43 years old 2. Body Mass Index (BMI): < 32 3. Presence of both ovaries 4. Indication for Dual Stim protocol 5. Compliance with the criteria to undergo IVF treatment. 6. Clinical history, history and physical examination without alterations. 7. AMH and RFA results according to group 3 or 4 of the Poseidon classification and not older than 6 months before the signature of the consent. 8. Ability to participate and comply with the study protocol. 9. To have given written consent 10. Normal karyotype and fragile X |
1. Edad: menos o igual a 43 años 2. Índice de Masa Corporal (IMC): < 32 3. Presencia de ambos ovarios 4. Indicación de pauta Dual Stim 5. Cumplimiento de los criterios para someterse en el tratamiento 6. Historia clínica, antecedentes y exploración física sin alteraciones 7. Resultado de AMH y RFA de acuerdo con el grupo 3 o 4 de clasificación Poseidon y no mayor a 6 meses antes de firma del consentimiento 8. Capacidad para participar y cumplir con el protocolo del estudio 9. Haber dado su consentimiento por escrito 10. Cariotipo y X frágil normal. |
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E.4 | Principal exclusion criteria |
1. Non-compliance with instructions and/or non-formalization of consents or legal requirements for IVF. 2. Concurrent participation in another study |
1. No cumplimiento de instrucciones y/o no formalización de consentimientos o requisitos legales para FIV. 2. Participación concurrente en otro estudio |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare the number of total oocytes and MII in patients with probable low ovarian response (Poseidon classification group 3 and 4) obtained in the 2nd cycle of a Dual Stim sequence applying in this Dual Trigger (aGnRH and hCG-rec together) vs. aGnRH or hCG-rec alone. |
Comparar el número de los ovocitos totales y MII en pacientes con probable baja respuesta ovárica (grupo 3 y 4 de clasificación Poseidón) obtenidos en el 2º ciclo de una secuencia de Dual Stim aplicando en esta Doble Trigger (aGnRH y hCG-rec juntos) vs. aGnRH o hCG-rec solos |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Egg collection of the second ovarian stimulation in the Dual Stim protocol. |
Recogida de óvulos enla segunda estimulación ovárica en el protocolo Dual Stim. |
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E.5.2 | Secondary end point(s) |
1. To analyze the number of total oocytes and MII obtained in the 1st and 2nd cycle of the Dual Stim sequence. 2. To analyze the number of blastocysts per patient. 3. To analyze the number of blastocysts vitrified per patient after the 1st and 2nd stimulation. 4. To analyze the implantation rate, clinical pregnancy, clinical miscarriage and biochemical miscarriage. 5. To analyze the newborn rate |
1. Analizar el número de ovocitos totales y MII obtenidos en el 1º y 2º ciclo de la secuencia Dual Stim 2. Analizar el número de blastocistos por paciente 3. Analizar el número de blastocistos vitrificados por paciente tras la 1ª y 2ª estimulación 4. Analizar la tasa de implantación, embarazo clínico, aborto clínico y aborto bioquímico. 5. Analizar la tasa de recién nacido |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Egg collection of the second ovarian stimulation in the Dual Stim protocol. 2, 3. Five to six days after the second egg collection. 4. up till 9 months after the second egg collection. 5. From 9 to 12 months after the second egg collection. |
1. Recogida de óvulos de la segunda estimulación ovárica en el protocolo Dual Stim. 2, 3. De cinco a seis días después de la segunda recogida de óvulos. 4. Hasta 9 meses después de la segunda recogida de óvulos. 5. De 9 a 12 meses después de la segunda recogida de óvulos. |
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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 | 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 | No |
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 | 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) | No |
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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End of the trial considered the day when the last patient undergoes her second egg collection in the Dual Stim IVF protocol. |
El final del ensayo se considera el día en que la última paciente se somete a la segunda recogida de óvulos en el protocolo de Dual Stim. |
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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 | |