De Placido 2005.

Methods	Prospective, randomized study, multicentred (7 centres). Randomisation method: in blocks of four using computer‐generated random number tables. Power analysis: a sample size of 55 patients in each group would have 80% power to detect a mean difference of 2.0. in mean number of retrieved oocytes. Study period: from February to December 2003. Sample size: 260. Conflict of interests: this study was realised with grants from the Ministero dell'Istruzione, dell'Università e della Ricerca.
Participants	Normo‐ovulatory women with an indication for IVF/ICSI and hysteroscopic evidence of a normal uterine cavity within the last 6 months. Age 18‐37 years. Basal FSH <= 9 IU/l. Exclusion criteria: BMI < 18 or > 28 kg/m2, biochemical and/or ultrasonographic evidence of polycystic ovarian syndrome, stage III‐IV endometriosis, chromosomal abnormalities, endocrinological and/or autoimmune disorders, more than two previously unsuccessful IVF or ICSI cycles, the presence of only one ovary. Baseline characteristics to compare: age, BMI, duration of infertility, basal FSH and indication for IVF/ICSI.
Interventions	Follicular started pituitary downregulation with GnRH agonist triptorelin 3.75 mg depot. 150‐300 IU rFSH. On stimulation day 5 women with an inadequate response (serum E2 levels < 180 pg/ml and ultrasound evidence of at least six follicles with a mean diameter between 6 mm and 10 mm, but with no follicle with a mean diameter of > 10 mm). Standard treatment: receive from stimulation day 6 onward rFSH in a step‐up protocol (daily increasing the dose with 150 IU/L) alone. Experimental treatment: rFSH in combination with 150 IU/L rLH until ovulation triggering with hCG.
Outcomes	Primary endpoint: the mean number of oocytes. Secondary endpoints: cumulative pregnancy rate (positive pregnancy test), cumulative ongoing pregnancy rate (pregnancies reaching 12 weeks of gestation), cumulative abortion rate (not defined), duration of stimulation, number MII oocytes, fertilisation rate, and cancellation rate.
Notes	Only data of the two truly randomized groups were included. Funding: This study was realised with grants from the Minestero dell'Istruzione, dell'Universita e della Ricerca
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was done in blocks of four using computer‐generated random number tables.
Allocation concealment (selection bias)	Low risk	Adequate, realised via a central telephone number.
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 provided on whether or not outcome assessors were blinded but non‐blinding of outcome assessment is not likely to affect outcomes of interest as they are objectively assessed.
Incomplete outcome data (attrition bias) All outcomes	High risk	Proportions of withdrawals and reasons for withdrawals differ between the two treatment groups and data were not analyzed on the basis of ITT.
Selective reporting (reporting bias)	High risk	Outcome measures were not prespecified in the methods section.
Other bias	Low risk	Baseline demographic characteristics similar between the two treatment groups.