Melo 2009.
| Methods | Randomised, controlled, assessor‐blinded, parallel‐group, single‐centre study | |
| Participants | 100 oocyte donors, 18 to 34 years of age, regular menstrual cycles, no family history of hereditary or chromosomal disease, normal karyotype, BMI 18 to 29 kg/m2 and negative screening for sexually transmitted disease. PCOS was excluded. Basic clinical donor characteristics show no differences in age, BMI and antral follicle 96 recipients were women with menopause, 32 (33%); low response, 28 (29%); premature ovarian failure, 27 (28%); and female advanced age, 9 (10%). 18 to 49 years of age, BMI 18 to 29 kg/m2, male partner without severe male factor (< 5 million fresh spermatozoa/mm3, < 5% normal forms and/or non‐obstructive azoospermia). Exclusion criteria: cases with uterine pathology (submucous or intramural fibroids > 2 cm, polyps, adhesions, adenomyosis or müllerian defects), implantation failure and recurrent miscarriage |
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| Interventions |
Oocyte donors Ovarian stimulation: OCP + adjustable dose of 225 IU rFSH + 0.25 mg cetrotide Intervention: 0.2 mg triptorelin SC vs 250 μg rHCG SC Luteal phase support (recipients): 800 mg/d micronised intravaginal progesterone |
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| Outcomes |
Donors: oocytes retrieved, proportion of MII oocytes, fertilisation rate, cleavage rate, top‐quality embryos, number of embryos transferred, OHSS rate Recipients: implantation rate, clinical pregnancy rate, multiple pregnancy rate, miscarriage rate |
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| Notes | Funding source is unclear | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
| Allocation concealment (selection bias) | Low risk | Third party random assignment by a nurse |
| Blinding (performance bias and detection bias) FOR OHSS OUTCOME | Low risk | All investigators, embryologists, laboratory personnel and sponsor staff, including the statistician responsible for statistical analysis, were blinded to treatment allocation throughout the study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No outcome data were missing |
| Selective reporting (reporting bias) | Low risk | Study protocol is not available. Live birth rate was not reported |
| Other bias | Low risk | No other potential bias was identified |