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Table 2 Primary and secondary effectiveness outcomes

From: Effectiveness and safety of follitropin alfa (Ovaleap®) for ovarian stimulation using a GnRH antagonist protocol in real-world clinical practice: a multicenter, prospective, open, non-interventional assisted reproductive technology study

 TTP
(N = 463)a
PPP
(N = 439)a
Primary effectiveness endpoints
Number of oocytes retrieved
 Total, n463439
  Mean (SD)11.7 (7.2)11.8 (7.2)
  (median; range)(10; 0–61)(11.0; 0–61)
 ICSI, n331314
  Mean (SD)12.1 (7.1)12.1 (7.1)
  (median; range)(11.0; 1–61)(11.0; 1–61)
 IVF, n117115
  Mean (SD)11.4 (7.0)11.5 (7.0)
  (median; range)(10; 2–38)(10; 2–38)
 No ARTb, n1410
  Mean (SD)3.3 (7.0)4.6 (8.0)
  (median; range)(0; 0–20)(0; 0–20)
 Missing, n10
  Mean (SD)0 (NE)
  (median; range)0 (0–0)
CPR
  Pregnant, n (%)165 (35.6)158 (36.0)
  Not pregnant, n (%)298 (64.4)281 (64.0)
CPR per embryo transfer, % (n/N)41.4 (165/399)41.3 (158/383)
Secondary effectiveness endpoints
Number of 2PN oocytes
  Mean (SD)5.8 (4.3)5.9 (4.2)
  (median;range)(5.0; 0–33)(5.0; 0–33)
Number of MII oocytes (ICSI patients only)
  Nc331314
  Mean (SD)9.2 (5.2)9.2 (5.2)
  (median; range)(8.0; 1.0–37.0)(8.0; 1.0–37.0)
Percentage fertilization rated
  Mean (SD)67.8 (27.4)68.3 (27.3)
  (median; range)(70.0; 0–300)(70.0; 0–300)
Day of transfer
  Day 1, n/N (%)1/399 (0.25)0/383
  Day 2, n/N (%)74/399 (18.5)72/383 (18.8)
  Day 3, n/N (%)150/399 (37.6)147/383 (38.4)
  Day 4, n/N (%)43/399 (10.8)43/383 (11.2)
  Day 5, n/N (%)124/399 (31.1)115/383 (30.0)
  Day 6, n/N (%)7/399 (1.8)6/383 (1.6)
Number of transferred embryos
  Mean (SD)1.8 (0.4)1.8 (0.4)
  Median2.02.0
Live birth delivery rate, n/N (%)e143/460 (31.1)138/437 (31.6)
  1. ART assisted reproductive technology, CPR clinical pregnancy rate, ICSI intracytoplasmic sperm injection, IVF in vitro fertilization, MII metaphase-II (mature oocytes), NE non-estimable, 2PN two pronuclei (normally fertilized oocytes), PPP per protocol population, SD standard deviation, TTP total treated population
  2. aUnless otherwise indicated
  3. bNo ART carried out for any reason, information not given by study centers
  4. cPerformed in patients with ICSI
  5. dCalculated as the percentage of 2PN oocytes out of the total number of MII oocytes
  6. eNumber of deliveries that resulted in a live birth among treated patients with follow-up information regarding live births