E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Infertile patients with at least three failed assisted reproductive tecniques |
Pazienti infertili con almeno tre tentativi falliti di procedure di fertilizzazione assistita |
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E.1.1.1 | Medical condition in easily understood language |
Infertile patients with at least three failed assisted reproductive tecniques |
Pazienti infertili con almeno tre tentativi falliti di procedure di fertilizzazione assistita |
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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 | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10036585 |
E.1.2 | Term | Pregnancy, puerperium and perinatal conditions |
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 |
The aim of the study is to evaluate the pregnancy rate in patients with repeated implantation failures undergoing a new ART cycle with or without LMWH administration. |
Valutare efficacia dell'eparina a basso peso molecolare nel favorire il successo delle tecniche di fertilizzazione assistita in donne infertili con almeno tre precedenti tentativi falliti |
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E.2.2 | Secondary objectives of the trial |
To evaluate the thrombophilic factor’s role in the clinical pregnancy rate in patients with at least three repeated implantation failures undergoing assisted reproductive techniques (ART) treated with or without weight adjusted LMWH |
Valutare il ruolo della trombofilia nella incidenza di gravidanza clinica in donne infertili con almeno tre precedenti tentativi falliti |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Women, 36-40 years •At least 6 good quality embryos transferred in 3 or more previous IVF/ICSI cycles without signs of implantation. •A normal response with at least 6 oocytes retrieved with standard induction protocol. •Total progressive motile count of at least 1.000.000 sperms/eiaculate. •No testicular or frozen sperms. •Normal uterine cavity as shown by SIS or ISC. •FSH < 10 mUI/ml. •AMH ≥ 1.0 ng./ml. •No hormonal, or immunological disorders detected •No APA or other severe thrombophilia detected •Normal female and male peripheral karyotype |
eta' 36 - 40 almeno tre precedenti cicli di IVF/ICSI falliti con trasferimento di almeno 6 embrioni di buona qualita' assenza malattie ormonali immunologiche o di anticorpi antifosfolipidi o trombofilia severa cariotipo periferico femminile e maschile normale, una conta di almeno 1000000 di spermatozoi mobili per eiaculato. non utilizzare sperma direttamente prelevato dal testicolo o congelato. normale cavita' uterina studiata mediante ecografia o isteroscopia. FSH < 10 mUI/ml. AMH ≥ 1.0 ng./ml. |
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E.4 | Principal exclusion criteria |
•Age <36 years or >40 years •Less than 3 previous IVF/ICSI cycles without signs of implantation •Total progressive motile count < than 1.000.000 sperms/eiaculate. • Testicular or frozen sperms. • Previous surgery for miomas and / or endometriosis. • Clinical or ultrasound diagnosis of endometriosis. • Patients treated in previous cycles with LMWH. • Hormonal, or immunological disorders detected • FSH < 10 mUI/ml or autoantibody positivity. • APA positivity or other severe thrombophilia |
Eta' inferiore a 36 e maggiore di 40 anni. meno di tre precedenti inefficaci IVF/ICSI, precedenti PMA con eparina a basso peso molecolare, FSH < 10 mUI/ml, una conta inferiore a 1000000 di spermatozoi mobili per eiaculato. utilizzo di sperma direttamente prelevato dal testicolo o congelato. assenza di una normale cavita' uterina studiata mediante ecografia o isteroscopia.presenza di trombofilia severa, anticorpi antifosfolipidi. presenza di malattie immunologiche concomitanti |
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E.5 End points |
E.5.1 | Primary end point(s) |
The aim of the study is to evaluate the pregnancy rate in patients with repeated implantation failures undergoing a new ART cycle with or without LMWH administration. |
Valutare efficacia dell'eparina a basso peso molecolare nel favorire il successo delle tecniche di fertilizzazione assistita in donne infertili con almeno tre precedenti tentativi falliti |
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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) |
To evaluate the thrombophilic factor’s role in the clinical pregnancy rate in patients with at least three repeated implantation failures undergoing assisted reproductive techniques (ART) treated with or without weight adjusted LMWH |
Valutare il ruolo della trombofilia nella incidenza di gravidanza clinica in donne infertili con almeno tre precedenti tentativi falliti |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | 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 |
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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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last patient last visit |
ultima visita ultimo soggetto |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |