Lainas 2010.
| Methods | RCT, single‐centre | |
| Participants | 220 PCOS women undergoing ICSI Inclusion criteria: PCOS (presence of oligo‐ovulation/anovulation) and polycystic ovaries, age 18 – 39 years, no endometriotic cyst present, as assessed by transvaginal ultrasound examination, basal FSH 10 IU/ml Exclusion criteria: women with known previous poor ovarian response Baseline characteristics:age (years) 32 (29 – 35) vs 31 (28 – 35), BMI (kg/m2) 23.2 (20.9 – 25.8) vs 24.6 (20.9 – 29.3), FSH (IU/l) 6.0 (4.3 – 6.9) vs 6.2 (4.8 – 7.5), LH (IU/l) vs 5.9 (3.4 – 7.6) 5.3 (4.0 – 7.5) |
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| Interventions |
GnRH antagonist (n = 110): OCP + 150 IU FSH on 2nd day of the cycle (adjusted) + 0.25 mg SC of cetrorelix acetate (Cetrotide) administered when at least one of the following criteria were fulfilled, the presence of at least one follicle measuring > 14 mm, serum E2 levels > 600 pg/ml; and serum LH levels > 10 IU/l (flexible protocol) GnRH agonist (n = 110): OCP (Cilest) + 150 IU rFSH (adjusted) + long GnRH agonist, 0.1 mg triptorelin three days before discontinuation of the OCP, once down‐regulation was achieved, the dose of GnRH agonist was decreased on that day to 0.05 mg/day (low‐dose GnRH agonist protocol) Oocyte maturation triggering: 3 follicles > 17 mm, 5000 IU of hCG was administered Oocyte retrieval: 35 ‐ 36 hours later, followed by IVF/ ICSI Maximum of embryo transferred: 3 Luteal phase support: 600 mg of micronised progesterone was initiated two days after oocyte retrieval Follow up: OPR was confirmed by vaginal ultrasound scan at 12 weeks of gestation |
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| Outcomes | The primary outcome measure: ongoing pregnancy rate per participant randomised. Ongoing pregnancy and clinical pregnancy were defined as the presence of gestational sac with fetal heart beat detection at 12 weeks and at 6 – 7 weeks of gestation, respectively Secondary outcome measures: OHSS incidence, duration of rFSH stimulation, total dose of rFSH, E2 and progesterone concentration on the day of hCG administration, cycle cancellation rate, number of cumulus‐oocyte complexes (COCs) retrieved, number of metaphase II oocytes and fertilisation rates | |
| Notes | OHSS classification: a modified classification system based on combined criteria previously reported (Golan 1989; Navot 1992; Rizk 1999) was used in the current study | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation list, in a 1:1 ratio |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) All outcomes | High risk | Neither participants nor doctors were blinded to the treatment assigned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data, however LBR not addressed by the study |
| Selective reporting (reporting bias) | Low risk | The study protocol was not available, but it is clear that the published reports included most expected outcomes |
| Other bias | Low risk | The study appears to be free from other sources of bias |