E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inability to conceive after a year of sexual relations free from any system of contraception |
Incapacità di concepire dopo 1 anno di rapporti sessuali liberi da qualsiasi sistema contraccettivo. |
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E.1.1.1 | Medical condition in easily understood language |
Inability to conceive. |
Incapacità di concepire |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10005160 |
E.1.2 | Term | Blighted ovum |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
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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 |
To evaluate whether prophylactic anticoagulation could improve the implantation rate in women subjected to PMA treatment. |
Valutare se la profilassi anticoagulante possa influenzare la probabilità di ottenere un impianto in pazienti che si sottopongono a procreazione medicalmente assistita. |
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E.2.2 | Secondary objectives of the trial |
Not declared. |
Non dichiarati. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: • age >18 • presence of one of the following risk factors: thrombophilia (Factor V Leiden, PG20210A mutation, MTHFR C677T gene mutation), 2 or more previous implantation failures •Informed consent |
Criteri di inclusione • Età >18 aa • Almeno uno dei seguenti fattori di rischio: presenza di trombofilia (Fattore V Leiden, Variante Protrombinica G20210A, mutazione C677T del gene della MTHFR), due o più pregressi fallimenti di IVF • Consenso informato |
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E.4 | Principal exclusion criteria |
Exclusion criteria; • age < 18; • deficiency of antitrombin, protein C, protein S, antiphospholipid antibodies, previous VTE • no informed consent. |
Criteri di esclusione: • Età <18 aa •deficit di antitrombina, proteina C, proteina S, anticorpi antifosfolipide, pregressi eventi tromboembolici • non accettazione del consenso informato. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Failure rate of the first implantation. |
Tasso di fallimento del 1° impianto |
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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) |
Not declared. |
Non dichiarato |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not declared |
Non dichiarato |
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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 | Yes |
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) | 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 |
nessun trattamento |
no treatment |
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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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |