E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Resveratrol may prevent the incidence of ovarian hyperstimulation syndrome by reducing the expression of VEGF and estradiol, improving the haemoconcentration and ascitis Re |
Resveratrol puede prevenir la aparición de un síndrome de hiperestimulación ovárica mediante la reducción en la expresión de VEGF y estradiol, mejorando la hemoconcentración y el incremento de volumen de líquido ascítico típico de este cuadro clínico. |
|
E.1.1.1 | Medical condition in easily understood language |
Resveratrol may prevent the incidence of ovarian hyperstimulation syndrome |
Resveratrol puede prevenir la aparición de un síndrome de hiperestimulación ovárica. |
|
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 |
Evaluate the effect of resveratrol on VEGF levels |
Evaluar el efecto del resveratrol en los niveles de VEGF |
|
E.2.2 | Secondary objectives of the trial |
Evaluate the effect of resveratrol on haemoconcentration, estradiol levels and ascitis |
Evaluar el efecto del resveratrol en la hemoconcentración, niveles de estradiol y en volumen de líquido ascítico. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Egg donors who meet the following criteria:
1. Number of follicles (>12 mm) > o = 21 in the last scan previous ovum pick-up. 2. Number of retrieved oocytes > o =21. |
Donantes de ovocitos que deben cumplan los siguientes dos criterios:
- Número de folículos (> 12 mm) > o = 21 en la ecografía del día de la inducción de la ovulación - Número de ovocitos recuperados > o = 21. |
|
E.4 | Principal exclusion criteria |
Exclusión criteria for egg donation: >35 years, polycystic ovary syndrome, endometriosis, severe systematic pathology, positive serologies for BHV, CHV o HIV, or altered karyotype. |
Los criterios de exclusión para donación de ovocitos: >35 años, SOP, endometriosis, patología sistémica grave, serologías positivas para VHB, VHC o VIH, cariotipo alterado |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Levels of VEGF |
Niveles séricos de VEGF |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
3, 6 and 9 days after ovulation triggering with GnRH agonist |
A los 3, 6 y 9 días tras la inducción de la ovulación con análogo de la GnRH |
|
E.5.2 | Secondary end point(s) |
Haemococentration, estradiol levels, levels of ascitic fluid, laboratory parameters |
Hemoconcentración, Niveles de estradiol, Volumen de líquido ascítico, Determinaciones bioquímicas |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
3, 6 and 9 days after ovulation triggering with GnRH agonist |
A los 3, 6 y 9 días tras la inducción de la ovulación con análogo de la GnRH |
|
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 | 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 | 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 | 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 | Yes |
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
|
LVLS |
Última visita del sujeto |
|
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 | 3 |
E.8.9.1 | In the Member State concerned days | |