Kontoravdis 2006.

Methods	Randomised Controlled Trial Study in two centres: a academic centre: Aretaieon University Hospital; a non‐academic centre: the Centre for Human Reproduction, Genesis Clinic; both in Athens, Greece. Patients recruited prospectively; patient sampling consecutively. Inclusion criteria: Women aged ≤41 with unilateral of bilateral hydrosalpinges; confirmed by HSG, suitability for IVF‐ICSI treatment, FSH on day 2/3 <12mIU/ml, no contraindications for laparoscopic surgery, no history of IVF attempts before recruitment, absence of other obvious pelvic pathology in females. Exclusion criteria: Not specified. 115 patients were recruited and randomised (50 to proximal tubal occlusion; 50 to salpingectomy; 15 to non‐intervention). 112 patients underwent IVF and were analysed. 3 women withdrew from IVF; 3 women didn't respond to ovarian stimulation and in 4 women IVF did not result in embryo's.  Follow‐up scheme: up to the first IVF cycle after tubal surgery. Type: ultrasound 4 weeks after ET.
Participants	Age (years (SD)): 31±4.5 vs 29.8±3.4 vs 3.4±5.3. Type (primary or secondary) of subfertility: primary subfertility in 92% vs 84% vs 87% of the patients; duration not stated. Previous investigation: included baseline FSH. Contributary causes for infertility: other obvious pathology was reason for exclusion. Previous treatments: no previous fertility treatment. Diagnosis of tubal pathology was confirmed with HSG.  Characteristics and distribution of tubal pathology: all patients had hydrosalpinges; bilateral in 70/115 patients (70% vs 54% vs 54%). 70/115 women (58% vs 64% vs 60%) had ultrasound visible hydrosalpinges.  Characteristics of IVF treatment: IVF protocol: a standard long antagonist protocol; ovarian stimulation; rec FSH; HCG; luteal phase support; ET on day 3. Doxycycline and prednisolon 6 days after oocyte retrieval. Number of ovarian stimulation cycles per woman: one Collected oocytes (mean±SD): 11.6±4.9 in the laparoscopic occlusion group; 12.1±5.0 in the salpingectomy group, 10.9±5.1 in the non‐intervention group. ICSI procedures: n=7(14.9%)in the laparoscopic occlusion group; n=6(12.5%) in the salpingectomy group, n=3(20%) in the non‐intervention group. Fertilized oocytes (mean±SD): 8.7±3.9 in the laparoscopic occlusion group; 8.53±4.0 in the salpingectomy group, 7.9±5.1 in the non‐intervention group. No of transferred embryo's: 118 in the laparoscopic occlusion group; 121 in the salpingectomy group, 36 in the non‐intervention group. Embryo's per ET (mean±SD) 2.6±0.6 in the laparoscopic occlusion group; 2.6±0.6 in the salpingectomy group, 2.6±0.8in the non‐intervention group. Number of transfers with all embryo's grade 2.7 in the laparoscopic occlusion group; 5 in the salpingectomy group, 1 in the non‐intervention group.
Interventions	Uni‐ or bilateral laparoscopic tubal occlusion by bipolar diathermy at two separate sites on the isthmic segment of the tube VERSUS uni‐ or bilateral salpingectomy; with transection 1 to 1.5 cm from the cornual section VERSUS no intervention. Criteria for surgery: unilateral of bilateral hydrosalpinges. Timing of surgery: 2 to 3 months after tubal surgery prior to IVF; time interval between randomisation to IVF in the control group:unclear. co‐interventions: none stated. Data on performer: not stated.
Outcomes	PRIMARY OBJECTIVES Ongoing pregnancy rate ‐ (pregnancy's beyond first trimester) per 100 ET. Clinical pregnancy rate ‐ (gestational sacs on ultrasound with fetal pole, 4 weeks after ET) per 100 ET. Ectopic pregnancy rate ‐ defined per 100 ET. Miscarriage rate ‐ abortion of clinical pregnancies (ultrasonographically identified pregnancies) per 100 ET. SECONDARY OBJECTIVES: Subgroup analysis for bilateral hydrosalpinges and ultrasound visible hydrosalpinges.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	Randomisation by computer generated randomisation in blocks.
Blinding? All outcomes. Participants, outcome assessors, clinicians, statisticians	High risk	The operator and the IVF performer were the same person in some cases.
Incomplete outcome data addressed? Intention to treat for primary outcome?	High risk	112 women analysed of 115 randomised. Intention to treat analysis not explicitly stated.
Free of selective reporting?	Low risk	No suggestions of selective outcome reporting.
Detection adequate?	Low risk	adequate detection of stated outcomes.
Source of funding stated?	Low risk	correspondence stated that there was no source of funding.
Powercalculation performed?	Unclear risk	Power calculation is performed and calculated sample sizes were achieved. However, power calculations in this trial were made with very large anticipated differences (46% vs73% comparing salpingectomy to tubal occlusion and 46% vs 14% comparing surgery to no surgery) and not performed correctly. It is quite unlikely that these anticipated differences would be achieved; and therefore it may be questioned whether the made power calculation was adhered to.
Loss to Follow‐up explained?	Low risk	Withdrawal and losses to follow‐up were explained.