Polycystic ovary syndrome Nutritional, Metabolic, Endocrine Ovarian dysfunction
Conditions
Interventions
Participants in the trial will be randomised to receive either metformin or placebo in addition to routine medication for the short GnRH antagonist IVF treatment protocol.
Treatment arm: metformin -
Sponsors
Leeds Teaching Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with a known diagnosis of PCOS (as defined by the Rotterdam European Society for Human Reproduction and Embryology/American Society for Reproductive Medicine [ESHRE/ASRM] sponsored PCOS consensus workshop group, 2004) 2. Women must have a normal serum follicular stimulating hormone (FSH) concentration (reference range 1 - 8.0 iU/L) 3. Women must be 20 - 39 years of age 4. Women must have a body mass index (BMI) less than or equal to 35 kg/m^2 5. Pre-treatment inclusion criteria to include: 5.1. Serum testosterone level less than 5.0 nmol/l 5.2. Normal prolactin level (reference range less than 600 mU/L) 5.3. Normal thyroid function test level (thyroid stimulating hormone [TSH] reference range 0.2 - 6.0 mIU/L) 5.4. Normal renal, liver and haematological indices
Exclusion criteria
Exclusion criteria: 1. Women on other oral-antidiabetic agents or blood-glucose lowering preparations 2. Women taking phenprocoumon 3. Women taking antivirals such as didanosine, stavudine, tenofovir 4. Women taking cimetidine 5. Women taking ketofen 6. Women who have radiological examinations using contrast media within the preceding 48 hours 7. Women with renal or hepatic impairment 8. Women who have had a recent myocardial infarct 9. Women with known vitamin B12 deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of confirmed moderate and severe ovarian hyperstimulation syndrome (OHSS) requiring hospitalisation within 6 weeks of IVF treatment cycle. Aim to determine if metformin reduces incidence. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Stimulation based measures: 1.1. Incidence of mild OHSS 1.2. Duration of stimulation (days) 1.3. Total dose of FSH used (units) 1.4. Number of follicles greater than 10 mm 1.5. Number of cycles cancelled 2. Biochemistry based measures: 2.1. Oestradiol concentration on day of oocyte retrieval 2.2. Anti-Mullerian Hormone (AMH) on day of oocyte retrieval 2.3. Testosterone concentration on day of oocyte retrieval 2.4. Fasting insulin concentration on day of oocyte retrieval 2.5. Fasting glucose on day on oocyte retrieval 2.6. Serum VEGF concentration on day of oocyte retrieval 2.7. Full blood count (FBC) on day of oocyte retrieval, embryo transfer and day 3 post transfer 2.8. Urea, creatinine and electrolytes (U&E) on day of oocyte retrieval, embryo transfer and day 3 post transfer 2.9. Liver function tests (LFT) on day of oocyte retrieval, embryo transfer and day 3 post transfer 3. Embryology based measures: 3.1. Number of oocytes collected 3.2. Number of metaphase II oocytes for fertilisation 3.3. Number of embryos 3.4. Number of embryos available for freezing 3.5. Quality of embryos 4. Pregnancy outcomes: 4.1. Biochemical pregnancy rate (positive serum hCG) 4.2. Clinical pregnancy rate (pregnancy demonstrable on USS) 4.3. Live birth rate | — |
Countries
United Kingdom
Outcome results
None listed