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 | 7.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042391 |
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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 primary objective of this study is to compare highly purified Menotrophin with Follitropin alfa with respect to ongoing pregnancy (determined by positive fetal heart action at more than or equal to 9 weeks after the first positive pregnancy test) in the treatment of 60 subfertile females undergoing IVF using a GnRH antagonist protocol to supress endogenous FSH and LH. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to compare the efficacy of highly purified Menotrophin with that of Follitropin alfa with respect to the secondary efficacy endpoints in the treatment of 60 subfertile females undergoing IVF using a GnRH antagonist protocol to supress endogenous FSH and LH. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The patients must meet all of the following inclusion criteria
Signed informed consent;
Subfertile premenopausal female patients eligible for IVF treatment;
Aged more than or equal to 20 and less than or equal to 35 years;
Body mass index of >18 and <32 kg/m2;
Normal endocrine assessment within the last 6 months;
Normal pelvic ultrasound (showing two ovaries, no ovarian abnormalities and normal uterus) within the last 6 months;
Receipt of no more than two previous cycles of IVF (or other ART);
At least 3 consecutive ovulatory menstrual cycles of 24-35 days, and documented evidence of ovulatory cycles within the previous 12 months;
No fertility-modifying treatment within the 3 months prior to this treatment cycle;
Infertility attributable to or in association with either tubal factor, or unexplained causes;
Sperm of partner classed as normal according to WHO 1999 criteria within the year prior to beginning therapy;
Negative serum beta-HCG pregnancy test prior to beginning therapy;
Clinically normal baseline haematology, clinical chemistry, and urinalysis parameter values, negative serum HBsAg and HIV antibody tests;
Screening endocrine test results (estradiol, LH, FSH, progesterone, prolactin, TSH) in early follicular phase within the normal limits for the clinical laboratory
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E.4 | Principal exclusion criteria |
The patient may not be entered into the study if any of the following exclusion criteria exist.
Presence of any clinically relevant systemic disease (e.g. insulin-dependent diabetes mellitus);
A history of or current endocrine disease, including polycystic ovary-like syndrome and hyperprolactinaemia;
A history of coagulation disorders;
Persistent ovarian cysts;
Contraindications for the use of gonadotrophins or GnRH antagonists;
A history of hypersensitivity to any of the constituents of the study medication or related compounds;
Three or more previous cycles of IVF (or other ART);
A history of alcohol abuse (more than 30 units per week on a regular basis);
History of chemo- or radiotherapy;
Currently breast-feeding, pregnant or with a contraindication to pregnancy;
Diagnosed poor responders in prior IVF treatment;
History of severe OHSS (4 or 5) in former IVF treatment;
Investigational drug within the 30 days prior to treatment;
Any other condition or history that the investigator considers might increase the risk to the individual.
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E.5 End points |
E.5.1 | Primary end point(s) |
Ongoing pregnancy rate, defined as positive fetal heart action at more than or equal to 9 weeks after the first positive pregnancy test, after the IVF treatment cycle. |
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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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
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) | 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) | 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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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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 | |