Hohmann 2003.
| Methods | RCT, university‐affiliated IVF centre, open‐label, parallel design, randomisation: 2:1 (cetrorelix:triptoreline) ratio | |
| Participants |
142 infertile women undergoing IVF/ICSI Inclusion criteria: age between 20 to 38 yrs; BMI 19 to 29 kg/m2; history of regular menstrual cycles, ranging from 25 to 35 days; no relevant systemic disease, severe endometriosis, or uterine and ovarian abnormalities; no more than three previous IVF cycles; and no previous IVF cycle with a poor response or ovarian hyperstimulation syndrome |
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| Interventions |
Group A: GnRH agonist triptoreline (Decapeptyl) 1 mg/d, SC starting one week before the expected menses (usually cycle day 21) + fixed daily dose of 150 IU rFSH SC (Gonal‐F) Groups B and C: GnRH antagonist cetrorelix (Cetrotide) 0.25 mg/d, SC commencing when the largest follicle had reached a diameter of 14 mm + rFSH was initiated on cycle day 2 (group B) or 5 (group C). (Flexiblle) Oocyte maturation triggering: when the leading follicle had reached a diameter of 18 mm or more and at least three follicles had reached a diameter of 15 mm or more, 10,000 IU hCG (Pregnyl) was administered Embryo transfer: 35 hrs before the planned time of oocyte retrieval followed by IVF with or without ICSI Maximum number of embryos transferred: 2 embryos were transferred at 3 ‐ 5 days Luteal support: intravaginal progesterone (P; Progestan, Organon; 200 mg, three times daily) was given from the day of oocyte retrieval until a urine pregnancy test was performed 17 days later |
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| Outcomes | Included patients (n = 142) Age (yr) Body mass index (kg/m2) FSH day 2/3 (IU/litre) Inhibin Bday 2/3 (ng/litre) Participants undergoing oocyte retrieval (n 104) n (% per started cycle) Cycle day start cetrorelix Day hCG FSH (IU/litre) LH (IU/litre) E2 (n mol/litre) P (n mol/litre) Number of follicles (10 mm) day hCG Number of follicles (15 mm) day hCG Number of oocytes retrieved Number of embryos Fertilisation rate per subject (%) Number of pregnancies (%) Number of ongoing pregnancies (%) Number of twin pregnancies (%) | |
| Notes | Number of participants at randomisation: 169 (cetrorelix: NA/ triptoreline: NA) Number of participants at stimulation: 142 (cetrorelix: 45/ triptoreline: 97) Number of participants at OPU: 104 (cetrorelix: 38/ triptoreline: 66) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
| Allocation concealment (selection bias) | Low risk | Schedule assigned via numbered sealed envelopes |
| Blinding (performance bias and detection bias) All outcomes | High risk | Not blind |
| 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 |