Metformin Treatment Before IVF in Women With Ultrasound Evidence of Polycystic Ovaries; a Prospective, Randomised, Double Blind, Placebo Study
- Women attending 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 was required.
- Polycystic ovaries diagnosed by ultrasound presence of ≥12 follicles measuring 2-9 mm
in diameter in at least one ovary and/or increased ovarian volume (≥10 ml).
- Written informed consent.
- Clinical manifestations of PCOS, including 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 nmol/L and/or free
androgen index >5 (FAI = [total testosterone/SHBG] x 100).
4. Clinical hyperandrogenism with hirsutism or acne requiring treatment at least
- Age >38 years.
- BMI >35 kg/m2.
- Basal FSH >12 IU/L.
- Liver disease or ALT >80 IU/L.
- Renal disease, or creatinine >130 nmol/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 mIU/L).
- Abnormal thyroid function tests (TSH outside of laboratory normal range).
- Congenital adrenal hyperplasia.