E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 |
Identify the optimal time interval between administration of the GnRH analogue triptorelin acetate and needle aspiration of oocytes |
Determinar el intervalo de tiempo óptimo entre la administración del análogo de la GnRH Acetato de Triptorelina y la punción-aspiración de los ovocitos |
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E.2.2 | Secondary objectives of the trial |
Identify the time necessary for the maturation of the oocyte after administration of triptorelin. Comparing the time interval between protocols optimum hCG and GnRHa. Evaluate the results achieved with the protocols of ovulation induction with GnRHa in IVF treatments and compare them with those obtained with the induction of ovulation with hCG. Assess overall response achieved with the protocol of ovulation induction with GnRHa. Evaluate and compare the sonographic criteria for ovulation induction in ultrasound in 2 and 3 dimensions. Compare and EGF hormone levels between follicles containing mature and immature oocytes induced cycles between GnRHa and hCG |
Determinar el tiempo necesario para lograr la maduración del ovocito tras la administración de la Triptorelina. Comparar el intervalo de tiempo de tiempo óptimo entre los protocolos con hCG y con GnRHa. Evaluar los resultados alcanzados con los protocolos de inducción de la ovulación con GnRHa en los tratamientos de FIV y compararlos con los obtenidos con la inducción de la ovulación con hCG. Evaluar la respuesta global alcanzada con los protocolo de inducción de la ovulación con GnRHa. Evaluar y comparar los criterios ecográficos de inducción de la ovulación en ecografía en 2 y 3 dimensiones. Comparar los niveles hormonales y de EGF entre folículos que contienen ovocitos maduros e inmaduros entre ciclos inducidos con GnRHa y hCG |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age less than or equal to 37 years. Sterility of tubal origin, unknown or treatable male factor IVF / ICSI using ejaculated semen (including frozen semen donor). Blood levels of basal FSH <10 mIU / ml on day 3 of the menstrual cycle. Serum AMH> 5 and <45 pmol / l Number of antral follicles> 6 and <24 between both ovaries |
Edad menor o igual a 37 años. Esterilidad de origen tubárico, origen desconocido o factor masculino susceptible de tratamiento mediante FIV/ICSI empleando semen de eyaculado (incluido semen congelado de donante). Concentración sanguínea de FSH basal < 10 mUI/ml en día 3 de ciclo menstrual. Concentración sérica de AMH >5 y <45 pmol/l Número de folículos antrales > 6 y <24 entre ambos ovarios |
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E.4 | Principal exclusion criteria |
Diagnosis of endometriosis severe (Grade III-IV). Diagnosis of SDM. polycystic ovaries (defined according to the Rotterdam criteria). History of low response in ovarian stimulation cycles prior defined as presence of less than 4 follicles greater than 16 mm or canceled cycle. All those patients who do not voluntarily give their express written consent Known allergy to the drug |
Diagnóstico de endometriosis severa (Grado III-IV). Diagnóstico de Sdm. de ovarios poliquísticos (definido acorde a los Criterios de Rotterdam). Historia de baja respuesta en ciclos previos de estimulación ovárica definido como presencia de menos de 4 folículos mayores de 16 mm o ciclo cancelado. Todas aquellas pacientes que de forma voluntaria no den su consentimiento expreso por escrito. Alergia conocida al fármaco. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of oocytes at metaphase II |
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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) |
Evaluate the results achieved with the protocols of ovulation induction with GnRHa in IVF treatments, regarding pregnancy rates achieved. Investigate the relationship between LH levels achieved after administration of triptorelin acetate and the rate of mature oocytes obtained in follicular puncture. Compare and EGF hormone levels between follicles containing mature and immature oocytes between GnRHa induced cycles. |
Evaluar los resultados alcanzados con los protocolos de inducción de la ovulación con GnRHa en los tratamientos de FIV, en lo referente a tasa de gestación alcanzada. Investigar la relación entre los niveles de LH alcanzados tras la administración de acetato de triptorelina y la tasa de ovocitos maduros obtenidos en la punción folicular. Comparar los niveles hormonales y de EGF entre folículos que contienen ovocitos maduros e inmaduros entre ciclos inducidos con GnRHa. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
It will determine the pregnancy rate after completing the monitoring of patients, when pregnancy is confirmed clinical trial completion, Transference 30-35 days after the embryo (ET + time 30-35). The determination of serum LH levels were performed at 12 postdesencadenamiento ovulation. The collection and processing of follicular fluid will practice at the time of the follicular puncture and aspiration of fluid from the follicles (described in the graph as time P). |
Se determinará la tasa de gestación tras completar el seguimiento de las pacientes, cuando se confirme gestación clínica a la finalización del ensayo, 30-35 días tras la trasnferencia embrionaria (momento ET + 30- 35). La determinación de los niveles séricos de LH se realizará a las 12 postdesencadenamiento de la ovulación. La recogida y procesamiento del líquido folicular se practicará en el momento de la punción folicular y aspiración del líquido de los folículos (descrito en el gráfico como momento P). |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
0.2 MG DECAPEPTYL / 36 HORAS |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |