This article has been corrected: The authors found several small errors and miscalculations, which were corrected, making text consistent with the Supplemental Clinical Study Final Report:
Table 1. Baseline characteristics (MFAS population).
7th row: The unit “month” for the “Duration of infertility” was corrected to “year”, making it consistent with the Supplemental Clinical Study Final Report.
13th row: The p-value (0.242) for “Fertilization procedure, n (%)” was corrected to “0.212”. In addition, a footnote “b” (The total number of evaluable patients was 110 in the Gonal-F® Pen group)” was added.
RESULTS, Patients
The p-value in the last sentence in the Patients section was changed from p = 0.242 to p= 0.212.
Corrected sentence: “The distribution of the patients according to fertilization procedure was similar between the groups (p= 0.212).” This is now consistent with value in the corrected Table 1.
RESULTS, Efficacy – Primary outcome
In the first sentence of the “Primary outcome” section, the abbreviation "±SD” was corrected to "±SE”, and the number 13 was corrected to 13.5. This SE value was estimated from an ad hoc analysis for this manuscript; the analysis source (SAS output) is available. The number 13.5 was based on a result from the Clinical Study Final Report (Table 15, available).
Corrected sentence: “The least square mean (±SE) number of oocytes retrieved was 14.9 (± 0.5; median [range]: 14 [1 to 41]) in the Follitrope group and 12.8 (± 0.9; median [range]: 13.5 [3 to 33]) in the Gonal-F group, showing a treatment difference of 2.1 oocytes.”
RESULTS, Efficacy – Secondary outcome
A subtraction error was corrected in the following sentence, which changed 44.3% to 44.6%.
Corrected sentence: “In the Follitrope group, 186 patients (55.4%) underwent ET in contrast to 79 patients (71.8%) in the Gonal-F group; thus, the cancellation rate was 44.6% and 28.2% in the Follitrope and Gonal-F groups, respectively (p = 0.0028).”
A numerical error was also corrected in the following sentence, which changed 35.3% to 35.5%.
Corrected sentence: “The percentage of embryos that were successfully implanted in patients showing gestational sacs (i.e., implantation rate) was 39.8% in the Follitrope group and 35.5% in the Gonal-F group (p = 0.376).” This correction makes the stated numbers consistent with Table 2.
Table 2. Efficacy outcomes (PP population).
3rd and 4th rows: For “No. of follicles with diameter of ≥14 mm on hGC day” and “E2 concentration on hGC day, pg/mL), a footnote “a” was added based on the final result from the Clinical Study Final Report (Tables 26 and 36).
5th row: For “No. of oocytes retrieved” the footnote “c” (Values are mean±SE)” was added, as requested above for the “Primary outcome” section in the RESULTS. In addition, the p-value was corrected from “0.022” to “0.057” based on the final result from the Clinical Study Final Report (Table 16).
Corrected Tables 1 and 2 are presented below.
Table 1. Baseline characteristics (MFAS population).
|
FollitropeTM PFS
(N = 336) |
Gonal-F® Pen
(N = 111) |
p-value | |||||
| Age, yearsa | 29.4 ± 3.9 | 29.3 ± 3.6 | 0.814 | ||||
| Age, n (%) | 0.376 | ||||||
| 20-30 yrs | 198 (59) | 73 (66) | |||||
| 31-35 yrs | 118 (35) | 31 (28) | |||||
| 36-39 yrs | 20 (6) | 7 (6) | |||||
| BMI, kg/m2a | 21.4 ± 2.7 | 21.3 ± 2.6 | 0.881 | ||||
| Duration of infertility, yeara | 3.9 ± 2.5 | 3.9 ± 3.1 | 0.805 | ||||
| Main reason for infertility, n (%) | 0.250 | ||||||
| Tubal factor | 149 (44.3) | 42 (37.8) | |||||
| Male factor | 105 (31.3) | 46 (41.4) | |||||
| Unexplained | 58 (17.3) | 15 (13.5) | |||||
| Combined | 24 (7.1) | 8 (7.2) | |||||
| Fertilization procedure, n (%)b | 0.212 | ||||||
| IVF | 182 (54.2) | 50 (45.5) | |||||
| ICSI | 130 (38.7) | 53 (48.2) | |||||
| IVF and ICSI | 24 (7.1) | 7 (6.4) | |||||
| Basal FSH level, mIU/mla | 3.0 ± 0.9 | 3.1 ± 1.0 | 0.827 | ||||
| Basal E2 level, pg/mLa | 21.4 ± 12.4 | 20.4 ± 10.6 | 0.498 | ||||
a Values are mean±SD
b Total number of evaluable patients were 110 for Gonal-F® Pen group.
Table 2. Efficacy outcomes (PP population).
|
FollitropeTM PFS
(N = 336) |
Gonal-F® Pen
(N = 110) |
p-value | |
| Total injected dose of r-FSH, IUa | 1945.3 ± 635.7 | 2020.2 ± 562.7 | 0.271 |
| Duration of treatment, daysa | 10.7 ± 1.6 | 11.1 ± 1.4 | 0.027 |
| No. of follicles with diameter of ≥14 mm on hCG day a | 10.2 ± 4.0 | 10.1 ± 4.4 | 0.750 |
| E2 concentration on hCG day, pg/mL a | 4460.0 ± 2564.1 | 4051.9 ± 2583.5 | 0.167 |
| No. of oocytes retrievedc | 14.9 ± 0.5 | 12.8 ± 0.9 | 0.057 |
| No. of Metaphase II oocytes, n (%)a,b | 85.3 ±14.0 | 85.0 ± 15.8 | 0.895 |
| Fertilization rate (%) | 70.6 | 74.6 | 0.079 |
| No. of embryos transferreda | 2.0 ± 0.3 | 2.0 ± 0.4 | 0.731 |
| Embryo implantation rate (%) | 39.8 (144/362) | 35.5 (55/155) | 0.376 |
| Biochemical pregnancy rate (%) | 4.3 (8/186) | 10.1 (8/79) | 0.110 |
| Clinical pregnancy rate (%) | 55.4 (103/186) | 51.9 (41/79) | 0.168 |
| Ongoing pregnancy rate (%) | 44.1 (82/186) | 43.0 (34/79) | 0.758 |
a Values are mean±SD
b ICSI patients only
c Values are mean±SE