Barmat 2005.
Methods | RCT, multi‐centre (4 US centres), open‐label, parallel design | |
Participants | 80 women undergoing IVF/ICSI Inclusion criteria: < 39 years of age, day 3 FSH level of < 10, E2 level of < 60 pg/mL, AFC > 5 with a menstrual cycle range of 26 ‐ 34 days, and no more than one previous failed IVF or IVF/ICSI cycle. BMI 19 ‐ 32 kg/m2 no hydrosalpinx present by hysterosalpingogram, laparoscopy, or ultrasound within the past year Male factor infertility cases could be included (ICSI and/or frozen sperm) with the exception of nonobstructive azoospermia. Only one study cycle was allowed Exclusion criteria: history of previous poor response (< 4 follicles and/or an E2 level of < 500 pg/mL on the day of hCG), had taken infertility medications (clomiphene and/or gonadotrophins) within the past month, or had failed to consent to taking OCs, GnRH‐analogues, or gonadotrophins. |
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Interventions |
GnRH antagonist (n = 40): OC (Desogen; Organon USA) on cycle days 2 to 4 for 14 to 28 days + 300 IU/day rFSH SC (adjusted) + 250 µg ganirelix was initiated when a lead follicle obtained a mean diameter of 12 to 14 mm (flexible) GnRH agonist (n= 40): leuprolide (GnRH‐agonist group), 0.5 mg per day during the mid‐luteal phase with approximately a 5‐day overlap with the OCs. Once adequate pituitary desensitisation was achieved the dose of GnRH agonist was reduced to 0.25 mg per day + 300 IU/day rFSH SC (adjusted) Oocyte maturation triggering: at follicular diameter 16 ‐ 18 mm, 5000 to 10,000 IU of hCG (Pregnyl). In cases at risk of ovarian hyperstimulation syndrome, the physician could give a dose of 5000 IU of hCG Oocyte retrieval: 35 to 36 hours later Embryo transfer: at 3 or 5 days Luteal phase support: progesterone, one centre treated women with P, 25 mg IM, on the day of retrieval, followed by P, 50 mg IM daily, with some women being supplemented with hCG 2,500 IU on days 3 and 6 after retrieval. The other centres prescribed luteal support with a daily dose of P (50 mg IM). |
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Outcomes | Participants to oocyte retrieval (n = 77) Days from OCP to oocyte retrieval Days on OC Stimulation day 1 E2 (pg/mL) Recombinant FSH (IU) Days of recombinant FSH Stimulation day of ganirelix start Days of leuprolide or ganirelix LH day hCG (IU/L) E2 day hCG (pg/mL) P4 day hCG (pg/mL) No of follicles Follicle sizes Number of oocytes retrieved Number of mature oocytes Number of 2 pronuclear embryos Number of embryos transferred Percentage of women with cryopreservation Embryos cryopreserved/participant with cryopreservation Number of pregnancies/embryos transferred (%) Number of pregnancies/cycle started (%) Number of ongoing pregnancies/embryos transferred (%) Number of ongoing pregnancies/cycle started (%) Number of implanted embryos (%) Number of ongoing twin gestations (%) Delivered pregnancies | |
Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Dark sealed envelopes (true), randomisation: 1:1 (ganirelix acetate: leuprolide acetate) ratio |
Allocation concealment (selection bias) | Low risk | Dark sealed envelopes (true) |
Blinding (performance bias and detection bias) All outcomes | High risk | Not reported clearly |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcomes data |
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 |