E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Polycystic ovary syndrome (PCOS) is a disorder characterized by polycystic ovaries, oligo-amenorrhea and hyperandrogenism. It is the most common endocrine disorder in women of fertile age. PCOS women are an - or oligoovulatory and often suffer from infertility or subfertility. Prevalence estimates vary between three and twenty percent depending on the diagnostic criteria used and the population studied. A prevalence of five to seven percent has been reported in Caucasian women. | |
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 | Does methormin treatment before IVF/ICSI in women with polycystic ovarian syndrome and normal body weight (BMI below 28 kg/m2)increase clinical pregnancy rate in IVF/ICSI? Clinical pregnancy rate defined as a verified intrauterine gestational sack week 7 in pregnancy. | |
E.2.2 | Secondary objectives of the trial | Number of oocytes collected - Embryo quality - Number of days with gonadotropin treatment in IVF cycle (ie. costs) - Dose of gonodotrophin, total pr cycle and daily - S-estradiol on day of hCG-injection - Occurrence of Ovarian Hyperstimulation Syndrome (OHSS) - Spontaneous pregnancy rates during pretreatment period. - Spontaneous abortion rates - Live birth rates | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria | More than one year of infertility in PCOS-women planned for IVF og ICSI - First or second cycle of IVF og ICSI treatment. - Age below 38 years at inclusion. - BMI below 28 kg/m2 at inclusion. - Patient willing to be randomised to 4 month treatment with metformin or placebo. - If previously on methformin, a 1 month wash-out period is required. - PCOS diagnosis based on the revised ESHRE/ASMR-2003 (Rotterdam)-criteriae; fullfilling at least two of the following three criteriae: - Oligoamenorrhea - Hyperandrogenism - Polycystic ovaries by ultrasound | |
E.4 | Principal exclusion criteria | More than one previous IVF cycle - Patients not suitable for starting dose 112.5 IE Gonal-F. - Basal s-FSH above 10 IE/L - Known liver disease, or s-ALAT above 80 IU/L - Known renal disease, os s-kreatinin obove 130 mmol/L - Known alcoholism or drug abuse - known diabetes mellitus, or fasting serum-glucosis above 6.7 nmol/L - Peroral steroid hormone treatment - Treatment with cimetidin, anticoagulantia, erythromycin or other macrolides - Hyperprolactinemia (se-PRL above 700 IE/L) - Abnormal thyroid function tests - Congenital adrenal hyperplasia - Androgen secreting tumors - Cushing disease - Unfit to participate of any other reason. | |
E.5 End points |
E.5.1 | Primary end point(s) | Clinical pregnancy rate following IVF or ICSI treatment in normal weight PCOS -women. Clinical pregnancy rate defined by an intrauterine gestational sack week 7 in pregnancy. | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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 | 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 | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description | |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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 | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |