E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ovarian stimulation in women undergoing assisted reproductive technology |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021930 |
E.1.2 | Term | Infertility NOS |
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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 overall objective of this trial is to: Compare the ovarian response in ART subjects administered GONAL-f according to the CONSORT calculator versus given a standard GONAL-f dose of 150 IU per day.
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The target population includes subjects with the following attributes: •female subject justifying an IVF/ET treatment, •between the age of 18 and 35 years (35 not included) at the time of the randomisation visit, •an early follicular phase (Day 2-4) serum level of basal FSH <12 IU/L measured in the centre’s own laboratory and taken within 2 months prior to down-regulation start. •BMI <30 kg/m2, •regular menstrual cycles between 21 and 35 days, •have both ovaries present, •male partner with semen analysis within the last 6 months prior to the randomisation visit considered adequate as per centre’s standard practice for IVF or intracytoplasmic sperm injection (ICSI). If these criteria are not met, the subject can only be entered if donor sperm will be used, •receiving long GnRH agonist protocol – Day 21-22 of preceding cycle until day of hCG. |
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E.4 | Principal exclusion criteria |
To be eligible for inclusion in this trial the subjects must not meet any of the following criteria: 1.Had ≥2 previous ART cycles with a poor response to gonadotrophin stimulation (defined as <5 mature follicles and/or < 3 oocytes collected) or had ≥2 previous ART cycles with a hyper response (defined as ≥25 oocytes retrieved), 2.Any medical condition, which in the judgement of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Merck Serono's Medical responsible, 3.Had previous severe OHSS, 4.Polycystic ovary syndrome to reduce the risk of the occurrence of OHSS, 5.Presence of endometriosis requiring treatment, 6.Uterine myoma requiring treatment, 7.Any contraindication to being pregnant and/or carrying a pregnancy to term, 8.Extra-uterine pregnancy within the last 3 months prior to screening, 9.History of 3 or more miscarriages (early or late miscarriages) due to any cause, 10.Tumours of the hypothalamus and pituitary gland, 11.Ovarian enlargement or cyst of unknown aetiology, 12.Ovarian, uterine or mammary cancer, 13.A clinically significant systemic disease, 14.Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner, 15.Abnormal gynaecological bleeding of undetermined origin, 16.Known allergy or hypersensitivity to human gonadotrophin preparations, 17.Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years prior to the screening visit, 18.Entered previously into this trial or simultaneous participation in another clinical trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
Endpoints: The primary efficacy endpoint will be measured by the total number of oocytes retrieved per subject following GONAL-f stimulation and human chorionic gonadotrophin (r hCG (Ovidrel/Ovitrelle) injection in both treatment arms. |
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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 | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
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) | No |
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 | 3 |
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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For administrative and safety reporting purposes the end of the trial will be defined as the date of the final clinical database lock. |
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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 | 18 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 18 |