E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stimulation of mulit-follicular development in patients undgergoing assisted reproductive treatment |
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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 |
The primary objective of this phase III study is to show equivalence between AFOLIA and Gonal-f®. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to compare therapy related outcomes and safety between AFOLIA and Gonal-f® |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Age between 20 and 38 years with regular menstrual cycles of 25-35 days First or second cycle in the present series of ART BMI ≥ 18 ≤ 30 kg/m2 Basal FSH < 10 IU/L (cycle day 2-5) E2 levels < 50pg/mL (< 0.18 nmol/L) at the day of FSH administration Antral follicle count (AFC) ≥ 10 to ≤ 25 follicles (sum of both ovaries) Infertility due to any of the following factors: tubal factor, mild endometriosis (ASRM stage 1-2), male factor, unexplained infertility Presence of both ovaries and normal uterine cavity (confirmed by transvaginal ultrasound within 6 months before randomisation) Willingness to participate in the study and to comply with the study protocol Informed consent
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E.4 | Principal exclusion criteria |
Patients will be excluded from study participation for the following reasons: Presence of pregnancy History of ≥2 succeeding ART cycles (IVF and/or ICSI) before the study cycle without clinical pregnancy Presence of clinically significant systemic disease Presence of chronic cardiovascular, hepatic, renal or pulmonary disease Presence of uncontrolled endocrine disorder Previous history or presence of severe ovarian hyperstimulation syndrome Presence of polycystic ovaries (PCO) Presence of severe endometriosis (ASRM stage 3 or stage 4) and hydrosalpinx Neoplasia Abnormal bleeding of undetermined origin History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt) Male infertility without mobile spermatozoa in the ejaculate, that need testicular of epididymal sperm retrieval (MESA/TESE/TESA) Endocrine abnormality such as TSH or prolactin level elevations outside the reference range if clinically relevant at screening Any hormonal treatment within 1 month before the start of the FSH treatment (with the exception of levothyroxin) History of drug, nicotine or alcohol abuse within the last 12 months (> 10 cigarettes/day) Administration of other investigational products within the last month Clinically abnormal findings at Visit 1 Planned PGS/PGD/PBB or assisted hatching Concomitant participation in an other study protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
To show equivalence between the two study groups with regards to number of oocytes retrieved |
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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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
E.8.1.3 | Single blind | Yes |
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.8.3 |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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A premature termination of the trial can happen upon decision of the sponsor, the concerned regulatory authorities, or ethics committees. Otherwise the trial is finished as soon as the requested number of patients are randomised. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |