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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, n

463

439

  Mean (SD)

11.7 (7.2)

11.8 (7.2)

  (median; range)

(10; 0–61)

(11.0; 0–61)

 ICSI, n

331

314

  Mean (SD)

12.1 (7.1)

12.1 (7.1)

  (median; range)

(11.0; 1–61)

(11.0; 1–61)

 IVF, n

117

115

  Mean (SD)

11.4 (7.0)

11.5 (7.0)

  (median; range)

(10; 2–38)

(10; 2–38)

 No ARTb, n

14

10

  Mean (SD)

3.3 (7.0)

4.6 (8.0)

  (median; range)

(0; 0–20)

(0; 0–20)

 Missing, n

1

0

  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)

  Nc

331

314

  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)

  Median

2.0

2.0

Live birth delivery rate, n/N (%)e

143/460 (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