Skip to main content
. 2017 May 24;2017(5):CD005070. doi: 10.1002/14651858.CD005070.pub3

Tarlatzis 2006.

Methods Prospective, randomized, placebo‐controlled trial.
 Randomisation: by means of a computer programme generated by Serono International S.A.
 Power analysis: In order to detect a difference of 2.5 in the mean number of MII oocytes between the two groups a 100 patients were needed.
Study period: Not stated.
Sample size: 123 patients.
Conflict of interests: Not stated.
Participants Patients with a normal uterus and two ovaries with an indication for IVF or ICSI.
 Age: between 18 and 37 years.
FSH: maximum 12 IU/l.
Exclusion criteria: previous poor respondents.
Baseline characteristics to compare: mean age, BMI, duration of infertility, primary/secondary infertility, cause of infertility: tubal factor, male factor, Semen characteristics: normal, abnormal.
Interventions Follicular started, pituitary downregulation with a GnRH agonist buserelin 200 mg subcutaneous until serum E2 < 200 pmol/l and no follicle > 15 mm. 150 IU rFSH was started adjusted if necessary on stimulation day 5. Once the leading follicle reached > 14 mm, patients were randomized.
Standard treatment: r‐hLH (lutropin alfa; Luveris, Laboratoires Serono S.A.), 75 IU subcutaneously for a maximum of 10 days.
Experimental treatment: placebo.
Outcomes Primary endpoint: mean number of MII oocytes.
 Secondary endpoints: duration of stimulation, the dose of rFSH required for stimulation, the number of fertilised embryo's, the number of cleaved oocytes, the pregnancy rate and live birth rate.
Notes No data on cryo‐survival. No data on multiple pregnancies. All IVF cycles were converted to ICSI.
Funding: this study was supported by Serono.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated.
Allocation concealment (selection bias) Low risk Adequate, sealed envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Non‐blinding is not likely to affect the outcomes of interest as they are objectively assessed.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk No information was reported on blinding of outcome assessment although non‐blinding of outcome assessment is not likely to affect the outcomes of interest as they are objectively assessed.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No loss to follow‐up; ITT analysis.
Selective reporting (reporting bias) Low risk Outcome measures were specified in the methods section.
Other bias Low risk Baseline demographic characteristics similar between the two treatment groups.