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 |
To evaluate the non-inferiority effect, and equal safety, of oral medroxiprogesterone acetate administered orally compared to GnRH antagonist on donor ovarian response. |
Evaluar la eficacia no inferior y seguridad igual del acetato de medroxiprogesterona adminsitrado por vía oral comparada con antagonista de la GnRH en la respuesta ovárica de las donantes. |
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E.2.2 | Secondary objectives of the trial |
To further evaluate the effect of medroxiprogesterone acetate on hormonal response, inhibition of the luteinizing hormone surge, embryological laboratory outcomes, reproductive outcomes in oocyte recipients and adverse events. |
Evaluar el efecto del acetato de medroxiprogesterona adminsitrado en la respuesta hormona, la inhibición del pico de hormona luteinizante, resultados de laboratoro embriológicos, resultados reproductivos en receptoras de ovocitos y efectos adversos. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Oocyte donors included in the oocyte donation program of Clinica EUGIN are healthy women younger than 35 years old with normal ovarian reserve. - 1st oocyte donation cycle at Clínica EUGIN. |
- Donantes de ovocitos incluidas en el programa de donación de ovocitos de la Clínica EUGIN (mujeres sanas de menos de 35 años con respuesta ovárica normal). - Primer ciclo de donación de ovocitos en la Clínica EUGIN. |
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E.4 | Principal exclusion criteria |
- Polycistic Ovarian syndrome (PCOs). - Estradiol levels on day 2 of menstrual cycle >70 pg/ml. - Hormone treatments up to 3 months before the oocyte donation cycle. - Medical contraindication to the treatments used in the study |
- Síndrome de ovario poliquístico. - Niveles de estradiol en día 2 del ciclo menstrual >70 pg/ml. - Tratamientos hormonal hasta 3 meses antes del ciclo de donación de ovocitos. - Contraindicación médica para la utilización de los tratamientos del estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Number of mature oocytes (MII) recovered at oocyte pick-up (OPU). |
- Número de ovocitos maduros (MII) recuperados en la punción folicular (OPU) |
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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) |
Controlled ovarian stimulation outcome variables - Total gonadotropin dose (international units) - Duration of stimulation (days) - Serum hormone profiles (FSH, LH, E2 and P4) during ovarian stimulation, at trigger day and just before OPU. - LH premature surge (yes/no), defined as LH>11 during ovarian stimulation - Cancellation rate: number of patients who have stopped COS before OPU/total number of patients - Number of cumulus (COC) recovered at OPU - Ratio MII/COC
Laboratory outcomes variables - Fertilization rate: number of oocytes fertilized/number of oocyte inseminated (%). - Embryo developmental score: qualification based on number of cells, symmetry, and percent of fragmentation in embryos (4-10 points).
Pregnancy outcomes variables - Biochemical pregnancy: positive pregnancy test in blood performed 14 days after the embryo transfer. - Clinical pregnancy: fetal heart beat observed at 7th week of gestation. - Implantation: number of fetuses observed/number of embryos transferred. |
Variables resultado de la estimulación ovárica controlada: - Dosis total de gonadotropinas (unidades internacionales) - Duración de la estimulación (días) - Perfil hormonal en suero (FSH, LH, E2 yP4) durante la estimulación ovárica, el día de la descarcarga y justo antes de la OPU. - Pico prematuro de LH (sí/no), definido como LH>11 durante la estimulación ovárica. - Tasa de cancelación: número de pacientes que pararo el ciclo de estimulación antes de la OPU / número de pacientes total. - Número de cúmulos (COC) recuerados en la OPU - Ratio MII/COC
Laboratory outcomes variables - Fertilization rate: number of oocytes fertilized/number of oocyte inseminated (%). - Embryo developmental score: qualification based on number of cells, symmetry, and percent of fragmentation in embryos (4-10 points).
Pregnancy outcomes variables - Biochemical pregnancy: positive pregnancy test in blood performed 14 days after the embryo transfer. - Clinical pregnancy: fetal heart beat observed at 7th week of gestation. - Implantation: number of fetuses observed/number of embryos transferred. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
OPU, day of ICSI and day of delivery (recipient). |
OPU, día de ICSI y día del parto (receptora). |
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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 | Yes |
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
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
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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 | 9 |
E.8.9.1 | In the Member State concerned days | |