E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Infertility. Assisted Reproductive Techniques. Fresh donated oocyte recipients |
Infertilidad. Técnica de Reproducción Asistida. Receptoras de ovocitos donados en fresco |
|
E.1.1.1 | Medical condition in easily understood language |
Infertility. Assisted Reproductive Techniques. |
Infertilidad.Técnica de Reproducción Asistida. |
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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 | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021928 |
E.1.2 | Term | Infertility female |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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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 |
Assess the impact on the rate of ongoing pregnancy at 12 weeks with the use of subcutaneous progesterone or vaginal progesterone capsules for endometrial preparation in fresh donated oocyte recipients |
estudiar el impacto en la tasa de embarazo en curso a las 12 semanas de gestación con el uso de progesterona subcutánea y progesterona vaginal en cápsulas para la preparación del endometrio, en mujeres sometidas a un ciclo de transferencia embrionaria en fresco con ovocitos de mujeres donantes. |
|
E.2.2 | Secondary objectives of the trial |
Serum progesterone thickness and morphology of endometrium implantation rate rate of biochemical pregnancy beta-hCG test positive clinical pregnancy rate abortion rate tolerability progesterone comfort relative to its route of administration |
nivel de progesterona el día de la transferencia y el día del test de embarazo bioquímico beta-hCG grosor y morfología del endometrio el día de la recogida de ovocitos y el día de la transferencia embrionaria tasa de implantación tasa de test positivo de embarazo bioquímico beta-hCG tasa de embarazo clínico tasa de aborto tolerabilidad confort de la progesterona en relación con su vía de administración. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Female age between 18 and 49 years (inclusive) Women who want pregnancy Endometrial thickness greater than 7 mm on the randomization of the patient is made to a group of progesterone more than 6 oocytes retrieved from the donor woman Patient scheduled for fresh embryo transfer on day +5 embryo culture BMI greater than 30 kg / m2 Infertility justify treatment with donor oocytes Women Males no known alterations in karyotype Semen ejaculation from either the partner or from bank Uterus able to support embryo implantation and pregnancy Absence of pregnancy before starting the cycle of embryo transfer Have consented in writing |
Edad de la mujer entre 18 años y 49 años (ambos inclusive) Mujer que desea el embarazo Grosos endometrial más de 7 mm el día que se realiza la aleatorización de la paciente a un grupo de progesterona más de 6 ovocitos recuperados de la mujer donante Paciente programada para la transferencia de embriones en fresco en un día +5 de cultivo embrionario IMC mayor de 30 Kg/m2 Infertilidad que justifique el tratamiento con ovocitos de mujeres donantes Varón sin alteraciones conocidas en el cariotipo Semen procedente de eyaculación bien de la pareja o procedente de banco Útero capaz de soportar la implantación del embrión y el embarazo Ausencia de embarazo antes de iniciar el ciclo de transferencia embrionaria Haber dado su consentimiento por escrito |
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E.4 | Principal exclusion criteria |
Important endocrine-metabolic Systemic diseases affecting pituitary, thyroid, adrenals, pancreas, liver or kidney Seropositivity for HIV, HBV or HCV Undiagnosed vaginal bleeding Pregnancy, lactation or contraindication for pregnancy Malformations of sexual organs incompatible with pregnancy Known allergy to preparations of progesterone or its excipients Current dependence on alcohol, drugs or psychotropic Concurrent participation in another study Concomitant medication that could interfere with study medication |
Enfermedades sistémicas importantes, endócrino-metabólicas que afecten hipófisis, tiroides, suprarrenales, páncreas, hígado o riñón Seropositividad VIH, VHB o VHC Hemorragias vaginales no diagnosticadas Embarazo, lactancia o contraindicación para quedar embarazada Malformaciones de los órganos sexuales incompatibles con el embarazo Alergia conocida a los preparados de progesterona o sus excipientes Dependencia actual de alcohol, drogas o psicofármacos Participación concurrente en otro estudio Medicación concomitante que pueda interferir con la medicación en estudio |
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E.5 End points |
E.5.1 | Primary end point(s) |
rate of ongoing pregnancy at 12 weeks |
tasa de embarazo en curso a las 12 semanas de gestación |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
ten weeks of progesterone treatment |
Diez semanas de tratamiento con progesterona |
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E.5.2 | Secondary end point(s) |
serum progesterone level endometrial thickness and morphology implantation rate rate of biochemical pregnancy beta-hCG test positive clinical pregnancy rate abortion rate tolerability progesterone comfort relative to its route of administration |
nivel de progesterona grosor y morfología del endometrio tasa de implantación tasa de test positivo de embarazo bioquímico beta-hCG tasa de embarazo clínico tasa de aborto tolerabilidad confort de la progesterona en relación con su vía de administración |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
serum progesterone level on the day of transfer (day 0) and day of biochemical beta-hCG pregnancy test (+14 days) thickness and morphology of endometrium on the day of oocyte collection (day 0) and day of embryo transfer (+5 days) implantation rate (+14 days) rates of biochemical pregnancy beta-hCG test positive (+14 days) clinical pregnancy rate (4 or 5 weeks) abortion rate (4 to 5 weeks) tolerability (+5 days +14 days, + 4-5 weeks weeks treatment +10) comfort of progesterone in relation to the route of administration (days +5, +14 days, +10 weeks of treatment) |
nivel de progesterona el día de la transferencia (día 0) y el día del test de embarazo bioquímico beta-hCG(+14 días) grosor y morfología del endometrio el día de la recogida de ovocitos (día 0) y el día de la transferencia embrionaria (+5 días) tasa de implantación (+14 días) tasa de test positivo de embarazo bioquímico beta-hCG (+14 días) tasa de embarazo clínico (4 ó 5 semanas) tasa de aborto (4 ó 5 semanas) tolerabilidad (+5 días, +14 días, +4-5 semanas, +10 semanas de tratamiento) confort de la progesterona en relación con su vía de administración (+5 días, +14 días, +10 semanas de tratamiento) |
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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 | Yes |
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 | No |
E.8.1.3 | Single blind | Yes |
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) | 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 | Yes |
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 |
ultima visita del último sujeto |
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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 | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |