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. 2010 Jan 20;2010(1):CD002125. doi: 10.1002/14651858.CD002125.pub3

Hammadieh 2008.

Methods Randomised controlled trial.
Single centre, non academic, trial in the Assisted Conception Unit of Birmingham Women's Hospital, UK. 
 Patient sampling unclear.
Inclusion criteria: a uni‐ or bilateral hydrosalpinx diagnosed by ultrasound during ovarian stimulation in the IVF cycle or previous to the IVF cycle, or women with severe tubal pathology on the waiting list for salpingectomy for hydrosalpinges. 
 Exclusion criteria: other major fertility factors.
66 women recruited and randomised (32 to aspiration; 34 to no intervention). 1,154 exclusions prior to randomisation. No women withdrew or lost to follow up. 66 women were analysed.
Follow‐up duration up to 1 IVF cycle. Type of follow‐up: biochemical pregnancy 14 days post ET; if positive ultrasound examination is performed 6 weeks post transfer. After diagnosis of viable pregnancy patients are referred to their GP.
Participants Age (years (SD)): aspiration group: 33.4±4.5 / no intervention group 33.9±4.7. 
 Type (primary/secondary) of subfertility: primary infertility 32/66 (aspiration group 41%, control group 56%). 
 Duration of infertility: not stated. 
 Previous investigative work‐up: not stated other than baseline FSH levels. 
 Contributary causes to infertility: exclusion criterion. 
 Previous treatments: no previous IVF treatment; not otherwise specified.
Diagnosis of tubal pathology: by ultrasound and by DLS or HSG in 7 patients. 
 Characteristics of tubal pathology: hydrosalpinges. 14 bilateral (8 in the aspiration group; 6 in the non intervention group).
Characteristics of IVF treatment: 
 Ovarian stimulation protocol: long antagonist protocol. 
 Single IVF ovarian stimulation cycle per woman. 
 Mean oocytes retrieved at IVF (SD) ‐ aspiration group 14.1 (7.1); non intervention group 12.4 (7.1).Proportion undergoing ICSI, 5% aspiration group; 7% non‐intervention group. Mean no. of fertilized oocytes in the aspiration group 9.2 (5.2); 7.0 (4.6) in the non‐aspiration group. Mean embryos transferred per cycles (SD) ‐ 2.3 (0.58) in the aspiration group; 2.1 (0.64) in the control group.
Interventions Aspiration of hydrosalpinx or hydrosalpinges after collection of all eggs (covered with intravenous Augmentin followed by 3 days of oral Azithromycin antibiotic) VERSUS no aspiration.
Criteria for surgical treatment prior to IVF ‐ Ultrasound visible hydrosalpinges (uni‐ or bilateral) during ovarian stimulation phase of IVF treatment or severe tubal pathology. 
 Timing of intervention: All interventions administered just after oocyte aspiration of the IVF cycle studied. 
 Cointerventions: antibiotics were administered in the aspiration group. 
 Data on performer: not stated.
Outcomes PRIMARY OUTCOMES 
 Biochemical (urinary HCG test 14 days after ET) and clinical (transvaginal ultrasound verified gestation sac) pregnancy per woman.
SECONDARY OUTCOMES 
 Ectopic pregnancy rate ‐ not defined; presumably per woman. 
 Miscarriage ‐ any pregnancy loss before 12 weeks. 
 Implantation rate ‐ number of gestational sacs on ultrasound divided by the number of embryos transferred. 
 Pelvic infection ‐ pelvic abdominal pain and pyrexia or positive culture of genital swabs 
 Recurrence rate of hydrosalpinges after aspiration.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk Randomisation by computer algorithm using a third party administrator just prior to oocyte retrieval procedure.
Blinding? 
 All outcomes. Participants, outcome assessors, clinicians, statisticians High risk Investigator nor the outcome assessor were blinded.
Incomplete outcome data addressed? 
 Intention to treat for primary outcome? Low risk 'Intention to treat' analysis performed (as there were no drop‐outs or losses).
Free of selective reporting? Low risk No suggestion of selective reporting.
Detection adequate? Low risk Follow‐up duration up to 1 IVF cycle.
Source of funding stated? Low risk No source of funding reported.
Powercalculation performed? High risk Power calculation performed ‐ sample size 158 not attained owing to decrease in recruitment rate by virtue of patient preference for salpingectomy, recruitment was stopped on advice of the Data Monitoring Committee after 4 years.
Loss to Follow‐up explained? Low risk Yes, no loss to follow‐up occurred.