Kovacs 2010.
Methods | Prospective randomized study, single centre. Randomisation method: in two blocks, method not stated. Power analysis: not stated. Study period: not stated. Sample size: 50. Conflicts of interest: nothing to disclose. |
|
Participants | Women with normal ovarian function undergoing their first or second IVF attempt. Age: < 40. AFC: not stated. FSH < 10 IU/l. Baseline characteristics to compare: age, baseline FSH and E2, suppression LH and E2, amount of gonadotropin. |
|
Interventions | Long luteal started pituitary downregulation with GnRH agonist with Suprefact 0.5 mg subcutaneous for 10 to 12 days until ovarian suppression was achieved than 75 IU rLH daily was started (cd 1) followed by 150 IU rFSH on cd 2. rLH was administered for 4 days and rFSH for 5 days. On cd 5 rFSH was adjusted if necessary and continued until ovulation triggering with rhCG. Standard treatment: 75 IU of rLH daily for 4 days and recombinant FSH (rFSH, Gonal F, Merck‐Serono) at a fixed starting dose of 150 IU for the first 5 days was started a day later, on day 2 of rLH. Experimental treatment: rFSH at a fixed‐dose of 150 IU for the first 5 days at suppression. |
|
Outcomes | Primary endpoint: effect on ovarian stimulation. Secondary endpoints: number of follicles, oocytes, high‐quality embryos, cryo‐preserved embryos and biochemical pregnancies (defined as serum bhCG) clinical pregnancies (defined as gestational sac two weeks after embryo transfer) and ongoing pregnancy rate (defined as positive heartbeat at 4 weeks after embryo transfer). |
|
Notes | No power analysis. Duration of infertility not stated. Funding: not stated |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomization (blocks of two). |
Allocation concealment (selection bias) | Unclear risk | No information on allocation concealment. |
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 | 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 | Low risk | No loss to follow‐up. |
Selective reporting (reporting bias) | Low risk | Outcome measures were prespecified in the methods section. |
Other bias | Unclear risk | Insufficient information to make a conclusive judgement. |