Farquhar 2002.
| Methods | Randomised trial conducted in Fertility Plus, National Women's Hospital, New Zealand Timing: mid 1996 to late 1999 |
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| Participants | 50 women randomised,3 cycles/participant, mean age 30 years, mean BMI 28 kg/m2, mean length of infertility: 36 months in the LOD group and 29 months in the gonadotrophin group Included: women aged 20 to 38 years with clomiphene‐resistant PCOS (150 mg clomiphene for 5 days), BMI < 32 (for European women) and < 34 (for Polynesian women) Excluded: Other known causes of infertility, including male‐factor infertility |
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| Interventions | Bilateral ovarian drilling by diathermy, versus
3 cycles of gonadotrophins (HMG or rFSH)
Laparoscopic ovarian drilling was performed with a diathermy needle creating 10 punctures/ovary, cooled with normal saline Follow‐up for 6 months |
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| Outcomes | Pregnancy rate 6 months after drilling or after 3 cycles of gonadotrophins (per participant), live birth, ovulation rate (per participant), costs | |
| Notes | Analyses on an intention‐to‐treat basis.
Powered to detect a 10% difference in ongoing pregnancy rate.
Definitions
PCO: clinical (oligo‐ or amenorrhoea) + ovarian appearance on ultrasound (criteria by Adams 1986)
Refractory PCO: failure to conceive after 3 cycles of ovulation induction with clomiphene citrate (150 mg/day)
Pregnancy: positive HCG and fetal heart on ultrasound
Ovulation: disappearance of a leading follicle or appearance of a corpus luteum on ultrasound OR mid‐luteal phase serum progesterone > 20 mmol/l Conflict of interest: not stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "computer generated sequences.." |
| Allocation concealment (selection bias) | Low risk | Quote: "sealed numbered opaque envelopes" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | There was no evidence that researchers or participants were blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details of blinding of outcome assessors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up |
| Selective reporting (reporting bias) | Unclear risk | We could not retrieve the original protocol. All outcomes listed in Methods were reported in the Results |
| Other bias | Low risk | No evidence of other risk of bias |