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Table 4 Secondary endpoints

From: A comparative, observational study evaluating dosing characteristics and ovarian response using the recombinant human follicle-stimulating hormone pen injector with small-dose dial in assisted reproductive technologies treatment in Asia: IMPROVE study

 

Full patient groups

At-risk for OHSS (matched groups)

Study group

Control group

Study group

Control group

(N=1783)

(N=1419)

(N=123)

(N=123)

E2 level on the day of hCG administrationa

 n (%)

1504 (84.4)

1011 (71.2)

53 (43.1)

113 (91.9)

 Missing, n (%)

279 (15.6)

408 (28.8)

70 (56.9)

10 (8.1)

 mean ± SD (pg/mL)

4058.3 ± 2663.5

3291.8 ± 2313.9

3317.3 ± 1116.6

2354.9 ± 1236.9

GONAL-f administration

    

 Initial dose of r-hFSH

    

  n (%)

1783 (100.0)

1419 (100.0)

123 (100.0)

123 (100.0)

  Missing, n (%)

0

0

0

0

  mean ± SD (IU)

191.7 ± 59.7

217.3 ± 60.2

174.4 ± 43.7

204.6 ±43.6

  Cycle day on which r-hFSH treatment was initiated

    

      n (%)

1776 (99.6)

1416 (99.8)

123 (100.0)

123 (100.0)

      Missing, n (%)

7 (0.4)

3 (0.2)

0

0

      mean ± SD (days)

5.4 ± 3.4

4.1 ± 2.7

6.9 ± 3.1

3.4 ± 2.4

    Total r-hFSH dose

    

  n (%)

1783 (100.0)

1419 (100.0)

123 (100.0)

123 (100.0)

  Missing, n (%)

0

0

0

0

  mean ± SD (IU)

1848.4 ± 700.5

2237.8 ± 772.6

1763.1 ± 587.2

2234.0 ± 782.2

 Daily r-hFSH dose

    

  n (%)

1783 (100.0)

1419 (100.0)

123 (100.0)

123 (100.0)

  Missing, n (%)

0

0

0

0

  mean ± SD (IU)

314.6 ± 182.1

326.8 ± 201.3

172.4 ± 45.6

213.5 ± 50.0

 r-hFSH dose per oocyte

    

  n (%)

1758 (98.6)

1408 (99.2)

123 (100.0)

123 (100.0)

  Missing or zero oocytes retrieved, n (%)

25

11

0

0

  mean ± SD (IU)

206.1 ± 253.2

268.8 ± 313.6

132.5 ± 85.2

332.7 ± 371. 6

 Duration of r-hFSH treatment

    

  n (%)

1783 (100.0)

1419 (100.0)

123 (100.0)

123 (100.0)

  Missing, n (%)

0

0

0

0

  mean ± SD (days)

9.6 ± 1.7

10.2 ± 1. 6

10.1 ± 1.4

10.3 ± 1. 5

 Patients with ≥1 dose adjustment (any amount)

841 (47.2)

Data not available

76 (61.8)

Data not available

 Patients with ≥1 dose adjustment of <37.5 IU, n (%)

105 (5.9)

6 (4.9)

Outcomes

    

  Implantation rate, %

30.0

20.6

38.4

12.7

     Clinical pregnancy rate, %

    

       per embryo transfer cycle

50.3

40.7

56.4 (31/55)

26.1 (30/115)

       per initiated cycle

35.3

37.8

25.2 (31/123)

24.4 (30/123)

     Live birth rate, %

    

       per embryo transfer cycle

43.8

34

49.1 (27/55)

20.9 (24/115)

       per initiated cycle

30.7

31.6

22.0 (27/123)

19.5 (24/123)

     Multiple pregnancy rate, %

    

       per embryo transfer cycle

16.2

12.6

21.8 (12/55)

4.3 (5/115)

       per initiated cycle

11.4

11.7

9.8 (12/123)

4.1 (5/123)

     Cycle cancellation rate, %

27.3

7.1

20.3 (25/123)

6.5 (8/123)

         Excessive response (risk of OHSS)b

 

55 (54.5)

0.0 (0.0)

3.0 (37.5)

         Inadequate responsebc

170 (34.9)

28 (27.7)

13.0 (52.0)

3.0 (37.5)

         Otherd

210 (43.1)

18 (17.8)

12.0 (48.0)

2.0 (25.0)

  1. E2 estradiol; GnRH gonadotropin-releasing hormone; hCG human chorionic gonadotropin; LH luteinizing hormone; N/A not applicable; OHSS ovarian hyperstimulation syndrome; r-hFSH recombinant human follicle-stimulating hormone; SD standard deviation
  2. aE2 values inconsistent with embryo transfer, i.e. ≥5000 pg/mL, for both the study group (n = 53) and control group (n = 113) were set to missing
  3. bDenominator for % calculation was total number of patients who had a cancelled cycle: n = 487 in the study group, n = 101 in the control group
  4. cReasons for an inadequate response in study group were lack of ovarian response to stimulation treatment (n = 115), no fertilization (n = 53), no oocytes retrieved (n = 2)
  5. dIn the study group, the main reason listed as ‘other’ (n = 210) was ‘frozen embryo transfer’ (n = 161); reasons for frozen embryo transfers were not detailed in the case report form. The other 49 cases were related to reduced implantation potential, insufficient or low quality eggs/embryos, or patient preference
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Reproductive Biology and Endocrinology

ISSN: 1477-7827

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