E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with diagnosis of low response (Bologna criteria) and who perform ovarian stimulation for accumulation of vitrified oocytes. |
Pacientes con diagnóstico de baja respuesta (Criterios de Bolonia) y que realizan estimulación ovárica para acumulación de ovocitos vitrificados. |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with diagnosis of low response to ovarian stimulation who perform Assisted Reproduction Techniques. |
Pacientes con diagnóstico de baja respuesta que realizan estimulación ovárica para tecnicas de reproduccion asistida. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016398 |
E.1.2 | Term | Female infertility |
E.1.2 | System Organ Class | 100000004872 |
|
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 efficacy of ovarian stimulation in luteal phase compared to ovarian stimulation in follicular phase in women with low responder criteria. |
Estudiar la eficacia de la estimulación ovárica en fase lútea comparada con la estimulación ovárica en fase folicular en mujeres con criterios de baja respondedora. |
|
E.2.2 | Secondary objectives of the trial |
-Assess whether there are differences between the two groups in terms of duration of stimulation -Study of the differences between the two groups in terms of consumption of gonadotropins and cost of treatment -Assess whether there are differences between the two groups in the rate of cancellation of the stimulation cycle -Assess whether there are differences between the two groups in the rate of oocytes in metaphase II stage -Assess whether there are differences between the two groups in the rate of survival in the thawing and fertilization rate after microinjection. |
-Evaluar si hay diferencias entre ambos grupos en cuanto a duración de la estimulación -Estudio de las diferencias entre ambos grupos en cuanto al consumo de gonadotropinas y coste del tratamiento -Evaluar si hay diferencias entre ambos grupos en la tasa de cancelación del ciclo de estimulación -Evaluar si hay diferencias entre ambos grupos respecto a la tasa de ovocitos en estadio de metafase II -Evaluar si hay diferencias entre ambos grupos en la tasa de supervivencia en la descongelación y tasa de fertilización tras microinyección. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
. Patient Bologna meets the criteria to be diagnosed as low responder. 2. Age under 41 years 3. Regular menstrual cycles between 21 and 35 days. 4. indication of in vitro fertilization 5. Indication of start stimulation with 300 IU of FSH 6. Presence of both ovaries 7. Ability to participate and comply with the study protocol 8. Having signed the written consent form |
1. Paciente que cumple los criterios de Bolonia para ser diagnosticada como baja respondedora. 2. Edad < 41 años 3. Ciclos menstruales regulares entre 21 y 35 días. 4. Indicación de fertilización in vitro 5. Indicación de iniciar la estimulación con 300 UI de FSH 6. Presencia de ambos ovarios 7. Capacidad para participar y cumplir con el protocolo del estudio 8. Haber dado su consentimiento por escrito |
|
E.4 | Principal exclusion criteria |
1. Presence of follicles larger than 10 mm in the randomization visit 2. Endometriosis III / IV 3. Concomitant uterine pathology: adenomyosis, submucosal myomas, Asherman's syndrome ... 4. Concurrent participation in another study |
1. Presencia de folículos mayores de 10 mm en la visita de randomización 2. Endometriosis III/IV 3. Patología uterina concomitante: Adenomiosis, miomas submucosos, síndrome de Asherman? 4. Participación concurrente en otro estudio |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Number of oocytes in metaphase II obtained |
Número de ovocitos en estadio de metafase II obtenidos |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of controlled ovarian hyperstimulation and oocyte maturation |
Final de la hiperestimulación ovárica controlada y la maduración ovocitaria |
|
E.5.2 | Secondary end point(s) |
- Number of oocytes cumulus complexes - Duration of stimulation (days) - Cycle cancellation rate - The LH levels following administration of agonist for final oocyte maturation day - Fertilization rate |
- Numero de complejos cumulo ovocitos obtenidos - Duración de la estimulación (días) - Tasa de cancelación - Niveles de LH el día posterior a la administración del agonista para la maduración final ovocitaria - Tasa de fertilización |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of controlled ovarian hyperstimulation and oocyte maturation |
Final de la hiperestimulación ovárica controlada y la maduración ovocitaria |
|
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 | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
Programa de tratamiento diferente |
Different treatment schedule |
|
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
|
LVLS |
Última visita del último paciente |
|
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 | 14 |
E.8.9.1 | In the Member State concerned days | |