E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Female sterility |
Sterilita' femminile |
|
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 | LLT |
E.1.2 | Classification code | 10016422 |
E.1.2 | Term | Female sterility |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
|
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 establish if Pergoveris can improve number of oocytes retrieved in a predefined poor responder ART patient population. |
Valutare se Pergoveris puo' migliorare il numero di ovociti recuperati in pazienti che presentano una bassa risposta quando sottoposte a protocolli di stimolazione ovarica in Tecniche di Procreazione Medicalmente Assistita |
|
E.2.2 | Secondary objectives of the trial |
See Main objective |
Vedi obiettivo principale |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- infertile patients aged 35 to 43 years inclusive; - regular cycles of 26-33 days; - tubal or male sterility; - idiopathic sterility only if exceeding 2 years; - no ovarian stimulation of any kind during the previous 3 months; - FSH on 3rd day >10 and < 15 mIU/mL; - previous FIVET or ICSI treatments with poor response to ovarian stimulation (both <5 oocytes collected, large amounts of gonadotrophins required); - written informed consent given before any trial-related activities are carried out. |
- pazienti infertili con eta' compresa tra 35 e 43 anni inclusi; - cicli regolari di 26-33 giorni; - fattore di sterilita' tubarico o maschile; - sterilita' idiopatica solo se superiore ai 2 anni; - nessun tipo di stimolazione ovarica indotta negli ultimi 3 mesi; - FSH al terzo giorno > 10 e < 15 mIU/mL; - precedenti cicli di FIVET o ICSI con bassa risposta a stimolazione ovarica (< 5 ovociti recuperati ed alta qualita' di gonadotropine richiesta); - consenso informato scritto ottenuto prima di iniziare qualunque procedura dello studio. |
|
E.4 | Principal exclusion criteria |
- infertile patients aged up to 34 and >= 44 years; - hypo-hypo patients; - participation in another clinical trial within the past 30 days; - known hypersensitivity to the trial treatment, or the comparator drug; - legal incapacity or limited legal capacity; - any clinically important systemic disease (e.g. insulin-dependent diabetes mellitus, epilepsy, serious migraine, intermittent purpura, hepatic, renal or cardiovascular disease, serious corticoid-dependent asthma) wich constitutes a controindication to gonadotropin use. |
- pazienti infertili con eta' < 34 anni e >= 44 anni; - pazienti ipo-ipo; - pazienti che hanno partecipato ad altri studi clinici negli ultimi 30 giorni; - ipersensibilita' nota verso il trattamento indicato nel protocollo o il trattamento standard di riferimento; - incapacita' legale o capacita' legale limitata; - qualsiasi malattia sistemica clinicamente significativa (es. diabete mellito insulino-dipendente, epilessia, grave emicrania, porpora intermittente, patologia epatica, renale o cardiovascolare, grave asma corticoide-dipendente) che possa costituire una controindicazione all'uso delle gonadotropine. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Number of oocytes retrieved. |
Numero di ovociti recuperati |
|
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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |