Table 5 Obstetric and perinatal outcomes (ITT analysis)

From: IVF versus ICSI in patients without severe male factor infertility: a randomized clinical trial

Parameters

ICSI (n = 414)

c-IVF (n = 408)

Risk difference (95% CI)

Risk ratio (95% CI)

P valuea

GDM

13/179 (7.3%)

14/193 (7.3%)

1 × 10−4 (−0.05 to 0.05)

1.00 (0.48–2.08)

1.00

Gestational hypertension

10/179 (5.6%)

12/193 (6.2%)

−6.31−3 (−0.06 to 0.04)

0.90 (0.39–2.03)

0.80

Preeclampsia/eclampsia

10/179 (5.6%)

13/193 (6.7%)

−0.01 (−0.06 to 0.04)

0.83 (0.36–1.84)

0.65

GA at birth, median (IQR)

 In weeks (rounded down)

40 (38–41)

40 (39–41)

–

–

0.94

 In days

281 (271–288)

281 (273–287)

–

–

0.69

 Missing datab

3/179 (2.9%)

4/193 (2.1%)

–

–

–

Birth method

 Vaginal birth

106/177 (59.9%)

108/191 (56.5%)

0.03 (−0.07 to 0.13)

1.06 (0.89–1.26)

0.52

 Vaginal birth with vacuum extraction

17/177 (9.6%)

29/191 (15.2%)

−0.06 (−0.12 to 0.01)

0.63 (0.35–1.1)

0.11

 C section

53/177 (29.9%)

54/191 (28.3%)

0.02 (−0.08 to 0.11)

1.06 (0.77–1.46)

0.72

 Planned

14/177 (7.9%)

14/191 (7.3%)

5.80 × 10−3 (−0.05 to 0.06)

1.08 (0.52–2.22)

0.83

 Emergency

39/177 (22.0%)

38/191 (19.9%)

0.02 (−0.06 to 0.11)

1.11 (0.74–1.65)

0.61

 Vaginal birth with forceps

1/177 (0.6%)

0

–

–

–

 Missing datab

2/179 (1.1%)

2/193 (1.0%)

–

–

–

 Preterm birth (before GA 37 + 0)

8/179 (4.5%)

10/193 (5.2%)

−7.12 × 10−3 (−0.05 to 0.04)

0.86 (0.34–2.14)

0.75

Sex of the baby

 Female

87/177 (49.2%)

87/189 (46.0%)

0.03 (−0.07 to 0.13)

1.07 (0.86–1.33)

0.55

 Male

90/177 (50.8%)

102/189 (54.0%)

−0.03 (−0.13 to 0.07)

0.94 (0.77–1.15)

0.55

 Missing datab

2/179 (1.1%)

4/193 (2.1%)

–

–

–

Birth weight, g

 Mean (s.d.)

3,386 (640)

3,433 (638)

0.03 (−0.02 to 0.09)

1.62 (0.76–3.64)

0.17

 Low birth weight (<2,500 g), n (%)

15/175 (8.6%)

10/193 (5.3%)

0.03 (−0.01 to 0.07)

2.88 (0.85–12.99)

0.22

 High birth weight (>4,500 g), n (%)

8/175 (4.6%)

3/193 (1.6%)

–

–

0.11

 Missing datab

4/179 (2.1%)

4/193 (2.1%)

–

–

–

 Congenital malformations

6/176 (3.4%)

8/189 (4.2%)

−8.24 × 10−3 (−0.05 to 0.03)

0.81 (0.27–2.27)

0.68

 Missing datab

3/179 (1.3%)

4/193 (2.1%)

–

–

–

  1. aThe P values for binary variables were calculated using a Wald test, with effect estimates (β) and s.e. derived from a generalized linear model. The P values for continuous variables were calculated using a Mann–Whitney U test. All tests were two sided.
  2. bMissing data on newborns or births are attributed to patients who either moved abroad before delivery (all of whom were contacted, and a live birth was confirmed either directly or through their medical records, although details on the child and birth method were unavailable from non-Danish medical records) or did not consent to access information from the newborns’ medical records.
  3. GDM, gestational diabetes mellitus.
Back to article page