Dechaud 1998.
Methods | Randomised controlled trial. Single‐centre, Department of Obstetrics and Gynaecology at a university hospital (Montpelier, France). Patient sampling: not explained. Inclusion criteria: women with severe tubal infertility, not suitable for tubal repair. Exclusion criteria: age >40 years; additional causes of infertility; tubal pathology suitable for repair by tubal catheterization, laparoscopic surgery, or microsurgical techniques; tubal pathology so severe as to require bilateral salpingectomy; lack of patient consent for salpingectomy or randomisation. 60 women recruited, 60 randomised (30 to laparoscopic bilateral salpingectomy and adhesiolysis; 30 to laparoscopic adhesiolysis). Number excluded not known. No loss to follow up. 60 women analysed. Follow‐up duration 1‐5 years. Follow‐up scheme: not specified. |
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Participants | Age </=40 years (range 27‐36).
Type (primary or secondary) of infertility: not stated.
Duration of infertility, mean months (SD): laparoscopic salpingectomy group 55.2 (33.3); laparoscopic adhesiolysis group 48.0 (25.4).
Investigative work‐up: baseline FSH, endocrine laboratory screening, semen analysis, post coital test, laparoscopy and confirmatory test of ovulation.
Other contributory causes: none
Previous treatment: no previous IVF.
Diagnosis of tubal pathology: by laparoscopy and(or) HSG; diagnostic criteria are specified.
Extent of tubal pathology: salpingitis isthmica nodosa or hydrosalpinx with a poor prognosis (disturbed with mucosal folds or irregular walls on HSG; proximal nodes or a thick walled hydrosalpinx). Distribution: unclear. Characteristics of IVF treatment: IVF protocol: a GnRH agonist protocol with hMG and hCG. Number of IVF ovarian stimulation cycles per woman: not stated. Mean oocytes retrieved per cycle (SD): 10.1 (5.0) in the salpingectomy group; 10.5 (6.0) in the laparoscopic adhesiolysis group. No ICSI. Fertilization rate: not stated. Mean number of embryos transferred (SD): 3.3 (1.2) in the salpingectomy group; 3.4 (1.2) in the laparoscopic adhesiolysis; up to 5 embryos were replaced in some cases. |
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Interventions | Laparoscopic bilateral salpingectomy and adhesiolysis VERSUS laparoscopic adhesiolysis. Criteria for surgical treatment prior to IVF: a communicating non‐draining hydrosalpinx with salpingitis isthmica nodosa. Mean interval from surgical intervention to IVF in months (SD): treatment group 10.1 (7.5); control group 9.5 (7.2). Cointerventions: none stated. Data on performer: not stated. |
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Outcomes | PRIMARY OUTCOMES
Ongoing pregnancy rate ‐ not defined; reported per transfer.
Pregnancy rate ‐ not defined; reported per transfer, per oocyte retrieval, per IVF cycle.
Cumulative pregnancy rates were presented also and obtained with the use of cumulative proportion test (the cumulative probability of becoming pregnant after each IVF attempt according to the number of patients, the number of pregnancies for each IVF attempt and the number of patients who discontinued IVF after each IVF attempt). The investigators hypothesized that the likelihood of becoming pregnant would have been equal for the patients who became pregnant after IVF and for those who discontinued IVF treatment. SECONDARY OUTCOMES Implantation rate ‐ not defined. Proportion of IVF cycles resulting in embryo transfer. Ectopic pregnancy and miscarriage rate ‐ not defined. |
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Notes | Subsequent publication of the cumulative results from this trial (Strandell 2001) were excluded from meta‐analysis (not intention to treat and too many protocol breached when intention to treat data was provided). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | With sealed opaque envelopes. |
Blinding? All outcomes. Participants, outcome assessors, clinicians, statisticians | High risk | No blinding. |
Incomplete outcome data addressed? Intention to treat for primary outcome? | Low risk | Intention to treat analysis is unclear; but number randomised is same as number analysed. |
Free of selective reporting? | Low risk | No suggestion of selective reporting. |
Detection adequate? | Low risk | Sufficient length of follow‐up: 1‐5 years. |
Source of funding stated? | Unclear risk | Presence or absence of funding is not reported. |
Powercalculation performed? | High risk | A power calculation was performed but not adhered to as the number calculated (322 patients in each group) would not be achieved in the setting of the trial. When the trial was ceased and the exact reasons for cessation are unknown. |
Loss to Follow‐up explained? | Low risk | No withdrawals or losses to follow‐up. |