E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016398 |
E.1.2 | Term | Female infertility |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016399 |
E.1.2 | Term | Female infertility (primary) |
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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 generate data on the ovarian stimulation profile obtained when Pergoveris® is started either on stimulation day 1 or stimulation day 6 in ART patients between 36 and 40 years of age (both inclusive). |
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E.2.2 | Secondary objectives of the trial |
To further investigate the efficacy and safety profile of Pergoveris® in ART patients between 36 and 40 years of age. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Female subject justifying an IVF/ET treatment, - Between her 36th and 40th birthday (both included) at the time of the randomisation visit, - Early follicular phase (day 2-4) serum level of basal FSH ≤12 IU/L measured in the centre’s local laboratory during the screening period (i.e. within 2 months prior to down regulation start), - Body mass index (BMI) < 30 kg/m2, - Regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length, - Presence of both ovaries, - Normal uterine cavity, which in the Investigator’s opinion is compatible with pregnancy, - Negative cervical PAP test within the last 6 months prior to randomisation, - At least one wash-out cycle (defined as ³ 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting GnRH agonist therapy, - Willing and able to comply with the protocol for the duration of the trial, - Having given written informed consent, prior to any trial-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care, - Having a male partner with semen analysis within the past 6 months prior to randomisation considered adequate to proceed with regular insemination or ICSI according to the centre’s standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used.
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E.4 | Principal exclusion criteria |
- Had ≥ 2 previous ART cycles with a poor response to gonadotrophin stimulation defined as ≤ 6 mature follicles and/or ≤ 4 oocytes collected in any previous IVF cycle or previous cycles with a hyper response defined as ≥ 25 oocytes retrieved, - Had ≥ 3 previous ART cycles, - Any medical condition, which in the judgment 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, - Previous severe OHSS, - Patients with primary ovarian failure, - Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS, - Presence of endometriosis requiring treatment, - Uterine myoma requiring treatment, - Any contraindication to being pregnant and/or carrying a pregnancy to term, - Extra-uterine pregnancy within the last 3 months prior to screening, - History of 3 or more miscarriages (early or late miscarriages) due to any cause, - Tumours of the hypothalamus and pituitary gland, - History or presence of ovarian enlargement or cyst of unknown aetiology, - Ovarian, uterine or mammary cancer, - A clinically significant systemic disease, - Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner, - Abnormal gynaecological bleeding of undetermined origin, - Known allergy or hypersensitivity to human gonadotrophin preparations, - Smoking ≥ 10 cigarettes per day, - Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years prior to the screening visit, - Entered previously into this trial or simultaneous participation in another clinical trial, - Pregnancy and lactation period, - Participation in another clinical trial within the past 30 days |
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E.5 End points |
E.5.1 | Primary end point(s) |
Total number of oocytes retrieved per subject following ovarian stimulation. |
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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 | 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) | 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.8.3 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
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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The end of the trial is defined as the time at which the last subject has completed her last visit, in accordance with EU regulations (EU Directive 2001/20/EC and EU Guidance ENTR/CT1) |
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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 | 3 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |