E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Infertile women undergoing IVF with sonographic evidence of polycystic ovaries but without any clinical manifestations of polycystic ovarian 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 |
To investigate if metformin treatment before IVF increases the live birth rate in women with ovulatory PCO who do not have other signs of PCOS. |
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E.2.2 | Secondary objectives of the trial |
• Duration of stimulation • Total dose of FSH • Peak estradiol • Endometrial thickness on day of ET • No. of follicles • No. of follicles >14 mm • Ovarian Hyperstimulation Syndrome(OHSS) requiring hospitalisation • No. of oocytes • No. of mature oocytes • No. of oocytes fertilised • No. of embryos >4 cells • Pregnancy rate • Clinical pregnancy rate
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Women attending the Oxford fertility unit with ovulatory PCO due to undergo IVF/ICSI treatment • First or second cycle of IVF/ICSI • If previously on metformin, a minimum one month washout period is required. • Polycystic ovaries diagnosed by ultrasound presence of 12 or more follicles in at least one ovary measuring 2-9 mm in diameter and/or increased ovarian volume (>10 ml)
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E.4 | Principal exclusion criteria |
• Clinical manifestations of PCOS. i.e. any of the following – 1. Oligo- or amenorrhoea with cycles ≥ 42 days apart 2. Anovulation with mid-luteal progesterone < 16 nmol/L. 3. Biochemical hyperandrogenism with serum testosterone ≥ 3.5 mmol/L and / or free androgen index > 5. 4. Clinical hyperandrogenism with hirsutism or acne requiring treatment at least weekly. • Age >38 • BMI >35 • Two or more previous IVF cycles • Basal FSH > 12 iu/L • Liver disease or ALT > 80 iu/l • Renal disease, or creatinine > 130 _mol/l • Alcoholism or drug abuse • Diabetes mellitus (evaluated by fasting glucose > 6.7mmol/l) • Per oral steroid treatment in last month • Cimetidine, anticoagulation, erythromycin, or other macrolides in last month • Hyperprolactinemia (Prolactin > 700 mU/L) • Abnormal thyroid function tests (TSH outside of laboratory normal range) • Congenital adrenal hyperplasia
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E.5 End points |
E.5.1 | Primary end point(s) |
Live birth of baby resulting from IVF treatment |
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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 | 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 | 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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |