Page 84 - PCC13

Aim of the study
Comparing Clomiphene Citrate and a short protocol with high doses of Gonadotropins in women with compromised ovarian reserve requiring IVF
Materials and methods
 Prospective multicenter non-inferiority RCT  Main inclusion criteria:
• Indication to IVF-ICSI
• Age 18-42 years
• Day 3 serum FSH > 12 IU/ml in at least two occasions OR
Previous poor response (≤3 oocytes retrieved) Arms of the study:
• Clomiphene Citrate oral tablets 150 mg/day from day 3 to day 7
• Short Protocol with 450 IU of s.c. recombinant FSH daily  Primary outcome: delivery rate (DR)
 Scheduled sample size: 472 subjects (236 per arm) in a two years period • Type I and II error of 0.05 and 0.80,
• Expected DR in the Short protocol group: 5% (Ragni et al., 2008)
• Largest difference to be regarded as negligible: 5%.  Supported by Regione Lombardia (ref. 7255/2008).
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