Giampaolino 2016.
| Methods | Parallel randomised controlled trial, conducted in Department of Obstetrics and Gynaecology, University of Naples, Italy Timing: December 2009 to July 2015 |
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| Participants | 246 women randomised, 201 analysed. Mean age of women in LOD group was 30.1 ± 7.5 years and in the THL group was 27.5 ± 6.8 years Inclusion criteria: Age 18 to 40 years, PCOS (Rotterdam 2003 criteria), clomiphene resistant Exclusion criteria: endocrine anomalies other than PCOS, any disease potentially responsible for ovarian adhesions, previous abdominal or pelvic surgery, presence of adhesions, fixed retroverted uterus, lateral displacement of the cervix, suspected pelvic tumour, vaginal infection, abnormalities at vaginal examination and transvaginal ultrasound, psychiatric disorder preventing ability to participate, obliteration of the Pouch of Douglas or inability to perform vaginal examination or any other contraindication to THL or laparoscopy |
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| Interventions | Laparoscopic ovarian drilling: Unipolar needle electrode with a power setting of 40 W for 4 to 5 seconds set at 30 W per ovary. 3 ‐ 6 punctures per ovary (n = 123), versus Transvaginal hydrolaparoscopy ovarian drilling: Bipolar electrosurgical probe and 3 ‐ 6 points per ovary drilled at a power setting of 110 ‐ 130 W (n = 123) . At 6 months, all women offered follow‐up with THL and asked to monitor menstrual cycles for next 12 months for spontaneous pregnancy |
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| Outcomes | Presence and type of adhesions, peri‐ and post‐operative complications, cumulative pregnancy rate, multiple pregnancy rate | |
| Notes | Only overall cumulative pregnancy rate reported in the paper. We contacted the authors 25 October 2016 for additional data on pregnancy rate by group No conflict of interest Clinical trial registration number: 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" |
| Allocation concealment (selection bias) | Low risk | Quote: "Allocation sequence was concealed from the researchers' 'sequentially numbered opaque, sealed and stapled envelope" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of surgeons or participants |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors of participants were blinded to allocation |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 246 women were randomised. 19 women in the LOD group refused follow‐up with THL and therefore follow‐up was completed on 104 women. 26 women in the THL group refused follow‐up with THL and therefore follow‐up was completed on 97 women. Unclear if cumulative pregnancy rate is for all 246 women or only for those who had follow‐up with THL |
| Selective reporting (reporting bias) | High risk | We could not retrieve the original protocol. Data for cumulative pregnancy are given as an overall value and not by group. Pregnancy rate and multiple pregnancy rate are not prespecified as outcomes in the Methods |
| Other bias | Low risk | Groups were balanced at baseline |