Moshin 2006.
Methods | Randomised Controlled Trial. Single academic centre, Center for Reproductive Health and Genetics, Chisinau, Moldova. Patients were recruited prospectively and consecutively. Inclusion criteria: women with hydrosalpinges. Exclusion criteria: not specified. 204 patients recruited and randomised (66 women randomised to no surgical treatment; 60 women randomised to salpingectomy; 78 randomised to proximal tubal occlusion) 204 women analysed. loss to follow‐up/withdrawal: none. Follow‐up duration: up to one IVF cycle. Type of follow‐up: diagnosis of pregnancy by ultrasound examination 21 days and 35 days after ET. |
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Participants | Age: similar in all groups; range: 22‐35 years
Type (primary or secondary): about 65% of the patients in each group were primary infertile. Duration of infertility: >2 years (mean months (SD): salpingectomy group: 46.2 (27.2); tubal occlusion group: 47.4 (28.5); non‐intervention group: 46.9 (27.8)). Previous investigative work‐up: ovulatory cycles, hormonal tests, transvaginal ultrasound examination of the genitalia interna, male semen parameters. Contributary causes to infertility: none. Previous fertility treatment: no previous IVF treatment. Diagnosis of tubal pathology: bilateral distal tubal occlusion diagnosed by HSG or ultrasound visible hydrosalpinges. Characteristics and distribution of tubal pathology: bilateral hydrosalpinges. IVF: Ovarian stimulation in a long course GnRH analogue protocol (Decapeptyl or Dipherelin) with a fixed doses (225 IU daily) of recombinant FSH for stimulation, starting on day 3 of the cycle. Ovarian response was monitored by ultrasonography and serum E2 concentration. Ovulation was triggered with 10000 IU of HCG (Pregnyl) when the leading follicles reached 18‐20 mm. Oocyte retrieval was carried out 36 hours after HCG administration. Retrieved oocytes were evaluated and fertilized by conventional insemination. Embryos were transferred on day 3 after insemination. : Utrogestan 400 mg/day vaginal from the day of ovum pick‐up until 12 week of pregnancy. Results reported over one cycle. Number of oocytes retrieved: 9.8±5.5 in the non‐intervention group / 10.4±6.0 in the salpingectomy group, 10.2±5.7 in the proximal occlusion group. Proportion undergoing ICSI: not stated. Fertilized oocytes: 6.8±4.6 in the non‐intervention group, 7.0±4.7 in the salpingectomy group, 6.9±4.6 in the proximal occlusion group. Mean number of preembryo's transferred: 3.5±1.3 in the non‐intervention group, 3.4±1.2 in the salpingectomy group, 3.4±1.3 in the proximal occlusion group. |
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Interventions | Salpingectomy VERSUS proximal tubal clamping of hydrosalpinges VERSUS No intervention . Criterium for intervention: ultrasound visible hydrosalpinges. Timing of intervention: minimally 2 months before IVF treatment. Timing to the IVF treatment cycle after randomisation in the control group: unclear. Cointerventions: not reported. Data on performer: not reported. |
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Outcomes | PRIMARY OUTCOMES: Clinical pregnancy ‐ gestational sac on ultrasound. |
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Notes | As data extraction on the abstract was limited; queries were resolved by contacting the author. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | By opaque numbered envelopes |
Blinding? All outcomes. Participants, outcome assessors, clinicians, statisticians | Unclear risk | Not stated. |
Incomplete outcome data addressed? Intention to treat for primary outcome? | Low risk | Not stated in abstract; but number of patients randomised is the same as numbers of patients analysed, correspondence clarified there was no loss to follow‐up or withdrawal. |
Free of selective reporting? | Low risk | no suggestions of selective reporting. |
Detection adequate? | Low risk | yes, adequate follow‐up after IVF. |
Source of funding stated? | Low risk | Source of funding: the Academy of Science of the Republic of Moldova (clarified by correspondence) |
Powercalculation performed? | Unclear risk | Not clear. As study sizes were small it may be presumed that they have not been adhered to if they where performed. |
Loss to Follow‐up explained? | Low risk | No loss to Follow‐up/ withdrawal, clarified by correspondence. |