Papanikolaou 2010.
| Methods | Proof‐of‐concept, single‐centre RCT | |
| Participants | 35 participants seeking IVF treatment. 4 participants refrained from further treatment (2 for personal problems, 1 became pregnant and 1 as the result of poor response). Inclusion criteria were as follows: younger than 36 years of age, elective single embryo transfer on day 5 and basal FSH less than 12 mIU/mL Exclusion criteria were as follows: polycystic ovary syndrome (PCOS); use of testicular sperm; and endometriosis stages III and IV. Age was 30.6 ±.0.8 vs 30.1 ± 0.7 years | |
| Interventions |
Ovarian stimulation: fixed dose 187.5 IU of recFSH (Gonal‐F; Merck‐Serono NV SA, Overijse, Belgium) starting on cd 2 of the cycle with GnRH antagonist, 0.25 mg cetrorelix (Cetrotide; Merck‐Serono) on cycle day 7 and continued daily until the day of trigger
Intervention: 17 participants were randomly assigned to standard treatment group. They received 250 mg recombinant HCG (Ovitrelle, Merck‐Serono, Geneva, Switzerland) for ovulation triggering and standard luteal P (600 mg micronised P vaginally administered from day after oocyte retrieval and maintained until 7 weeks of gestation). 18 participants were randomly assigned to the novel protocol. They received 0.2 mg of triptorelin (Ipsen, Boulogne Billancourt, France) for ovulation triggering Luteal phase support: standard P luteal support plus 6 doses every other day of 300 IU recombinant LH (Luveris, Merck‐Serono), starting on the day of oocyte retrieval up to day 10 after oocyte retrieval |
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| Outcomes |
Primary outcomes: implantation rates. Clinical pregnancy (defined as cardiac activity at 7 weeks) is similar to implantation rate, as a single blastocyst was transferred Secondary outcomes: OHSS incidence |
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| Notes | Medications used in the study were offered by Merck‐Serono, Overijse, Belgium | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Research nurse randomly assigned women to 1 of the 2 arms |
| Allocation concealment (selection bias) | Low risk | Allocation concealment was ensured by the research nurse |
| Blinding (performance bias and detection bias) FOR OHSS OUTCOME | Unclear risk | Treating physician was blinded to the allocation group until the day of trigger. Unclear whether outcome assessment was blinded. Risk applies to assessment of OHSS |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | TPP and ITT were provided |
| Selective reporting (reporting bias) | Unclear risk | Protocol was available, outcomes were as described. Live birth rate was not reported |
| Other bias | Low risk | No other potential bias was identified |