E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042012 |
E.1.2 | Term | Sterility |
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 |
Comparing gestational outcomes like pregnancy rate, clinical pregnancy rate, miscarriage rate or live birth rate between patients pretreated with estrogen pills, contraceptive pills and no pretreated . |
Comparar la tasa de gestación, aborto y recién nacido vivo observadas en los grupos pre tratados y el no pre tratado en pacientes sometidas a ciclo de FIV en protocolo con antagonistas. |
|
E.2.2 | Secondary objectives of the trial |
-To evaluate cancellation rate in order to insufficient ovarian stimulation in each group
-To evaluate adverse effects like hyperstimulation ovarian syndrome in each group
-To evaluate the number of ovarian follicles observed by US and the number of ovocytes obtained after puncture, as well as ovocyte quality in the different study groups.
-To observe hormonal basal values of FSH and estradiol before to ovarian stimulation and the possible effect over gestational outcomes.
-To observe hormonal values of E2 and Progesterone previously to ovulation induction, and the potential effect over endometrial receptiveness and implantation rates
-To evaluate treatment days and gonadotropin total doses necessary to get ovarian stimulation in each group.
|
- Valorar la tasa de cancelación de los ciclos por estimulación ovárica insuficiente obtenida en los diferentes grupos
- Valorar el hallazgo de posibles complicaciones como la hiperestimulación ovárica observada en los diferentes grupos.
- Valorar el número de folículos ováricos observados ecográficamente y el número de ovocitos obtenidos determinando la calidad ovocitaria de los mismos en los diferentes grupos a estudio.
9
- Observar los valores hormonales de FSH y estradiol al inicio de la estimulación, de estradiol pico, de progesterona el día de inducción de la ovulación con HCG por la posible implicación en la receptividad endometrial por alteración de los receptores hormonales a este nivel y por tanto, en el resultado gestacional.
- Valorar el grosor y el patrón endometrial previo a la transferencia por su posible relación con el resultado gestacional.
- Valorar los días necesarios para la estimulación ovárica y las dosis de gonadotropinas administradas en los grupos.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients belong to La Paz University Hospital, Human reproductive service that begin a GnRH antagonist FIV-ICSI cycle.
-Patients between 18-40 years diagnosed of primary sterility for several causes like male factor, tubal factor, endometriosis of low grade and low ovarian reserve.
-Patients with a BMI < 30kg/m2
-Regular ovulation cycles (each 26-35 days)
-Patients with less than 3 FIV-ICSI cycles performed
-Hormonal basal values of FSH <14 UI/ml and Estradiol < 80 pg/ml.
-Patients who signed the informed consent.
-Presence of both ovaries.
|
-Pacientes del servicio de Reproducción del Hospital Universitario La Paz que inicien un tratamiento FIV-ICSI con protocolo de estimulación ovárica con antagonistas de la GnRH.
- Pacientes entre 18 y 40 años con esterilidad primaria previa por diversas causas como factor masculino, factor tubárico, endometriosis grado I-II, baja reserva ovárica o esterilidad primaria de origen desconocido.
- Pacientes con un IMC < 30Kg/m2
- Presencia de ciclos ovulatorios regulares (cada 26-35 días)
- Realización de < 3 ciclos FIV-ICSI
- Pacientes con valores hormonales basales el 3º día del ciclo de FSH < 14 IU/ml y estradiol < 80 pg/ml.
- Pacientes que otorguen el consentimiento informado.
- Presencia de ambos ovarios |
|
E.4 | Principal exclusion criteria |
-Endometriosis high grade
-Endometrial pathology or uterine malformations previously diagnosed
-Ovarian polycystic syndrome according to Rotterdam criteria
-Presence of hydrosalpinx
-Intolerance or allergy to some drug
-Severe male factor (<100.000 REM or severe oligoasthenozoospermia)
|
-Endometriosis grado III-IV
- Patología endometrial o malformación uterina diagnosticada previamente
- Síndrome de ovario poliquístico de acuerdo con los criterios de Rotterdam
- Presencia de hidrosalpinx no extirpados
- Intolerancia o alergia a alguno de los fármacos
- Factor masculino severo (< 100.000 REM o semen de biopsia testicular o oligoastenozoospermias severas) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Gestational outcomes like pregnancy rate per cycle, clinical pregnancy rate per cycle, clinical miscarriage rate per cycle, live birth rate per cycle. |
Obtención o ausencia de gestación, la consecución de gestación con recién nacido vivo o la interrupción de la gestación antes de la semana 22, además de la tasa de cancelación y síndrome de hiperestimulación en los diferentes grupos a estudio |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
-Cancellation rate
-Hyperstimulation ovarian syndrome
-Hormonal basal values of FSH and Estradiol
-Hormonal values of E2 and Progesterone previously to ovulation induction
-Ovarian follicles observed after ovarian stimulation
-Ovocytes obtained after puncture, number of embryo complex and embryo quality
-Gonadotropin total doses used to get ovarian stimulation
-Total treatment days with gonadotropins
-Endometrial thickness before the embryo transfer.
|
- valores hormonales (FSH y E2 al inicio del ciclo y E2 y progesterona previa a la inducción de la ovulación)
- folículos ováricos observados ecográficamente tras la estimulación ovárica
- ovocitos obtenidos tras punción y calidad embrionaria
- las dosis de gonadotropinas utilizadas
- los días de estimulación
- el grosor y patrón endometrial previo a la transferencia embrionaria. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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) | 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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
brazo sin tratamiento |
no treatment |
|
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
| 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |