Author and year | Study size (n1/n2) | RCT | Inclusion and exclusion criteria | Corifollitropin alfa protocol | Recombinant FSH protocol |
---|---|---|---|---|---|
Devroey et al, 2009 [12] | 756/750 | yes | Women aged 18–36 y with a body weight >60 kg up to and including 90 kg, a BMI of 18–32 kg/m2, a menstrual cycle length of 24-35 days, access to ejaculatory sperm, and an indication to COS before IVF or ICSI. | Patients started their treatment cycle on menstrual cycle day 2 or 3. Single s.c. injection 150 μg corifollitropin alfa, or matching placebo. From stimulation day 8 onwards treatment was continued with a daily s.c. of rFSH up to and including the day of hCG administration. The maximum rFSH dose to continue treatment after the first 7 days was for 7 d + ≤ 200 IU (from sd 8) rFSH + GnRH antagonist (ganirelix, 0.25 mg). 5000–10,000 IU urinary hCG. Progesterone ≥600 mg/d vaginally or at least 50 mg/d IM. | Placebo + 200 IU rFSH + 200 IU (from sd 8) rFSH + GnRH antagonist (ganirelix, 0.25 mg). 5000–10,000 IU urinary hCG. P ≥600 mg/d vaginally or at least 50 mg/d IM. |
Exclusion criteria: endocrine abnormality, abnormal blood biochemistry or hematology, abnormal cervical smear, chronic disease, relevant ovarian, tubal or uterine pathology that could interfere with COS embryo implantation or pregnancy, history of ovarian hyper-response (>30 follicles >11 mm) or OHSS, PCOS, or basal AFC >20 on ultrasound, or women with history of low ovarian response to FSH or hMG treatment, basal FSH or LH >12 IU/L in early follicular phase, >3 consecutive unsuccessful IVF cycles, history of ≥3 recurrent miscarriages, smoking >5 cigarettes per day. | |||||
Ensure, 2010 [14] | 268/128 | yes | Women aged 18–36 y with body weight ≤60 kg, BMI 18–32 kg/m2, normal menstrual cycle length (24–35 days). | Single injection 100 μg corifollitropin alfa SC + placebo for 7 d + ≤ 200 IU (from sd 8) rFSH + GnRH antagonist (ganirelix, 0.25 mg). 5000–10,000 IU urinary hCG. Progesterone ≥600 mg/d vaginally or at least 50 mg/d IM. | Placebo + 200 IU rFSH (follitropin beta) + ≤200 IU (from sd 8) rFSH + GnRH antagonist (ganirelix, 0.25 mg). 5000–10,000 IU urinary hCG. Progesterone ≥600 mg/d vaginally or ≥50 mg/d IM. |
Exclusion criteria: The same as those reported in the Engage trial. | |||||
Corifollitropin Alfa Dose-Finding Study Group, 2008 [9] | 242/83 | yes | Women aged 20–39 y with a normal menstrual cycle (24–35 days) and a BMI 17–31 kg/m2. | Single SC dose of 60, 120, or 180 μg corifollitropin alfa + 150 IU (from sd 8) rFSH (follitropin beta) + GnRH antagonist (ganirelix, 0.25 mg) up to the day of hCG administration (10,000 IU). Daily progesterone to support luteal phase. | 150 IU rFSH + GnRH antagonist (ganirelix, 0.25 mg) up to the day of hCG administration (10,000 IU) 10,000 IU hCG. Daily progesterone to support luteal phase. |
Exclusion criteria: history of OHSS, PCOS, or any endocrine abnormality, previous poor response to FSH or hMG, more than 3 unsuccessful COS cycles, fewer than 2 ovaries, abnormal hormone levels during days 2–7 of menstrual cycle, use of hormonal preparations within 1 month before treatment or previous use of corifollitropin alfa. | |||||
Devroey et al., 2004 [15] | 75/24 | yes | Women aged 18–39 y, BMI 18–29 kg/m2, with a regular menstrual cycle (24–35 days). | Single SC dose of corifollitropin alfa) of 120, 180, or 240 μg followed one week later by 150 IU rFSH + GnRH antagonist (ganirelix, 0.25 mg). 10,000 IU of hCG. Vaginal micronized P (600 mg/d) or IM P (≥50 mg/d). | 150 IU rFSH + GnRH antagonist (ganirelix, 0.25 mg) starting on the day that the leading follicle had reached 14 mm. 10,000 IU urinary hCG. Vaginal micronized P (600 mg/d) or IM progesterone (≥50 mg/d). |
Exclusion criteria: Not indicated | |||||
Requena et al., 2013 [3] | 63/68 | yes | Oocyte donors aged 18-35 y with a regular menstrual cycle, no hereditary or chromosomal diseases, normal karyotype, at least 7 antral follicles at the beginning of the cycle, body weight ≥60 kg and BMI ≤29 kg/m2. | Oral contraceptive pill for a maximum of 21 days preceded ovarian stimulation. Single injection 150 μg corifollitropin alfa. From stimulation day 8 onwards treatment was continued with a daily s.c. of rFSH 200 IU if needed. GnRH antagonist (ganirelix, 0.25 mg). A single dose of GnRH agonist (0.1 mg Decapeptyl) to trigger final oocyte maturation. | Oral contraceptive pill for a maximum of 21 days preceded ovarian stimulation. 200 IU rFSH + GnRH antagonist (ganirelix, 0.25 mg). A single dose of GnRH agonist (0.1 mg Decapeptyl) to trigger final oocyte maturation |
Exclusion criteria: Oocyte donors who had PCOS based on Rotterdam criteria or multifollicular ovaries. | |||||
Kolibianakis et al., 2015 [16] | 40/39 | yes | Women poor responder aged <45 y. Characteristics of corifollitropin alfa versus daily FSH group: mean age (40.1 ± 3.3 vs. 40.1 ± 3.7 years, respectively; p = 0.96), mean BMI (26.1 ± 3.4 vs. 26.2 ± 3.5 Kg/m2, respectively; p = 0.95), mean basal FSH (12.3 ± 4.6 vs. 11.1 ± 3.2 IU/L, respectively; p = 0.46). | Single dose of 150 μg (0.5 mL) corifollitropin alfa + GnRH antagonist (from sd 5 onwards) until hCG + 250 μg of rehCG + daily dose of recFSH (450 IU/day) (from sd8 until the day of hCG, if necessary) + vaginal micronized progesterone (600 mg/day). | Previous IVF cycle with a starting dose of at least 450 IU per day + GnRH antagonist (from sd5 onwards) until hCG + 250 μg of rehCG + daily dose of recFSH (450 IU/day) (from sd8 until the day of hCG, if necessary) + vaginal micronized progesterone (600 mg/day). |
Boostanfar et al, 2012 [17] (Pursue trial) | 694/696 | yes | Women aged 35–42 years. | During the first 7 days of ovarian stimulation, single injection of 150 μg CFA. When required, they continued the cycle with daily rFSH (maximally 300 IU) until 3 follicles reached ≥17 mm. Ganirelix acetate (0.25 mg) was started on stimulation day 5 and recombinant human chorionic gonadotropin was given to trigger oocyte maturation. Three days after oocyte pick-up, 2 embryos were transferred. | Daily 300 IU rFSH for 7 days. When required, they continued the cycle with daily rFSH (maximally 300 IU) until 3 follicles reached ≥17 mm. Ganirelix acetate (0.25 mg) was started on stimulation day 5 and recombinant human chorionic gonadotropin was given to trigger oocyte maturation. Three days after oocyte pick-up, 2 embryos were transferred. |