E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Polycystic ovary syndrome. |
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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 prinicpal research objective is to determine if the administration of the drug metformin to women with polycystic ovary syndrome who are undergoing IVF treatment following the short GnRH antagonist treatment protocol reduces the incidence of moderate to severe ovarian hyperstimulation syndrome (OHHS) (i.e. Does metformin reduce the risk of OHSS in this group?). |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are to determine if metformin co-treatment would also improve other IVF outcomes: 1. Does metformin co-treatment lead to more favourable stimulation characteristics, including lower total dose of FSH required for stimulation, number and qulaity of eggs produced, duration of stimulation? 2. Does metformin co-treatment improve the biochemical markers of polycystic ovary syndrome and ovarian hyperstimulation syndrome? 3. Does metformin co-treatment improve the number and quality of embryos developed in the IVF cycle? 4. Does metformin co-treatment improve the chances of getting pregnant with IVF treatment? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women who will be invited to take part in this study would be subject to following inclusion criteria: •Women with a known diagnosis of PCOS (as defined by the Rotterdam ESHRE/ASRM sponsored PCOS consensus workshop group, 2004) •Women must have a normal follicular stimulating hormone (FSH) •Women must be 20-39 years of age •Women must have a BMI ≤ 35 •Pre-treatment inclusion criteria would include: oSerum testosterone < 5.0 nmol/l oNormal prolactin oNormal thyroid function tests oNormal renal, liver & haematological indices |
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E.4 | Principal exclusion criteria |
Women who do not conform to the above criteria would be excluded from the study In addition to the above these specific exclusion criteria would apply: •Women on other oral-antidiabetic agents or blood-glucose lowering preparations. •Women taking phenprocoumon •Women taking antivirals such as didanosine, stavudine, tenofovir. •Women taking cimetidine •Women taking ketofen •Women who have radiological examinations using contrast media within the preceding 48 hours. •Women with renal or hepatic impairment •Women who have had a recent myocardial infarct •Women with known vitamin B12 deficiency |
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E.5 End points |
E.5.1 | Primary end point(s) |
The aim of the proposed study would be to compare the stimulation characteristics, biochemical profiles and IVF-ET outcomes in women with PCOS undergoing IVF treatment following the standard short GNRH antagonist protocol for ovarian stimulation with or without metformin. Primary Outcome Measure: •Incidence of moderate and severe OHSS requiring hospitalisation within 6 weeks of the 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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | 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 | 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 | 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 | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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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End of trial defined as the final visit made by the last subject to the RMU as part of their treatment cycle. |
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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 | 6 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 30 |