Table 4 Fertility 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 ratio (95% CI)

P valuea

Number of retrieved oocytes

3,628

3,412

–

–

Median (IQR)

7 (5.0–11.0)

8 (4.0–11.0)

–

0.82

Missing data

1b/414 (0.2%)

1b/408 (0.2%)

–

–

Number of 2PN oocytes

1940c

1983d

–

–

Median (IQR)

4 (2.0–6.0)

4 (2.0–7.0)

–

0.30

Missing data

0

0

–

–

Fertilization rate per oocyte retrieved (2PN rate)

1,940/3,628 (53.5%)

1,983/3,412 (58.1%)

0.92 (0.88–0.96)

≤0.001

Number of MII oocytes

2914e

–

–

–

Median (IQR)

6 (4.0–9.0)

–

–

–

Unavailable data

3e

–

–

–

Missing data

0

–

–

–

Fertilization rate per inseminated MII (2PN rate)

1,940/2,914 (66.6%)

–

–

–

TFF

20/414 (4.8%)

15/408 (3.7%)

1.29 (0.68–2.54)

0.44

Participants with no oocytes retrieved, n (%)

3/414 (0.7%)

9/408 (2.2%)

0.32 (0.07–1.09)

0.09

Number of embryos transferred (fresh + FET)

580

593

–

–

Transfer cycles,f median per person (IQR)

1 (1–2)

1 (1–2)

–

0.33

Missing data

0

0

–

–

Number of SETg (%)

580/580 (100%)

593/593 (100%)

–

–

Number of eSETh (%)

476/580 (82.1%)

502/593 (84.7%)

0.97 (0.92–1.02)

0.24

Number of DET (%)

0

0

–

–

Missing data

0

0

–

–

Number of cleavage stage transfers (%)

19/580 (3.3%)

25/593 (4.2%)

0.78 (0.43–1.39)

0.40

Number of blastocyst transfer (%)

561/580 (96.7%)

568/593 (95.8%)

–

–

Missing data

0

0

–

–

Number of fresh embryo transfers (%)

243/580 (41.9%)

253/593 (42.7%)

0.98 (0.86–1.12)

0.79

Number of FET (%)

337/580 (58.1%)

340/593 (57%)

–

–

Missing data

0

0

–

–

EURi

984/1940 (50.7%)

1,115/1,983 (56%)

0.89 (0.85–0.96)

≤0.001

Number of cleaved embryos on D2j

1,938c

2,101d

–

–

Median per person (IQR)

4 (2.0–6.0)

4 (2.0–7.3)

–

0.05

Number of high-quality embryos on D2j

783c

821d

–

–

Median per person (IQR)

1 (0–3.0)

1 (0.5–3.0)

–

0.75

Missing data

0

0

–

–

Number of high-quality blastocysts on D5k

779c

886d

–

0.07

Median per person (IQR)

1 (0–3.0)

2 (0–3.0)

–

–

Missing data

0

0

–

–

Participants with at least one cryopreserved embryo, n (%)

242/414 (68.5%)

268/408 (65.7%)

0.89 (0.80–0.99)

0.03

Number of cryopreserved embryos total

742

862

–

–

Median per personl (IQR)

1 (0–3)

1 (0–3)

–

0.03

Median number of cryopreserved embryos among participants with at least one cryopreserved embryo

  

–

–

Median per person (IQR)

2 (1–4)

2 (1–4)

–

0.59

Participants with cryopreserved embryos available 1 year after inclusion of last participant, n (%)

136 (32.9%)

151 (37.0%)

0.89 (0.73–1.07)

0.21

Number of remaining cryopreserved embryos 1 year after last included patient

383

484

–

–

Median per person (IQR)

0 (0.0–1.0)

0 (0.0–2.0)

–

0.10

Participants without a live birth, n (%)

235 (56.8%)

215 (52.7%)

1.08 (0.95–1.22)

0.24

Participants without live birth with cryopreserved embryos available, n (%)

18/235 (7.7%)

16/215 (7.4%)

1.03 (0.54–1.99)

0.93

Number of remaining cryopreserved embryos in participants without a live birth

48

47

–

–

Median per person (IQR)

0 (0.0–0.0)

0 (0.0– 0.0)

–

0.95

  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. bOocyte retrieval canceled by the patient.
  3. cIn total, 4 with no oocytes retrieved and 20 with TFF.
  4. dIn total, 15 with TFF and 10 with no oocytes retrieved.
  5. eFour with no oocytes retrieved and three who received c-IVF and not ICSI by mistake.
  6. fThose with no embryos to transfer are included in the median.
  7. gSET (all single embryo transfers, including those with only one embryo available and those with multiple embryos available).
  8. heSET (deliberate transfer of a single embryo, even when multiple embryos are available).
  9. iEUR (numerator—includes embryos that were either transferred during fresh cycles or cryopreserved; denominator—total number of 2PN).
  10. jHigh-quality embryos on day 2:4 cells, maximum 10% fragmentation, mononucleated. If time-lapse imaging is used, only 2PN, and if time-lapse is not used, 2PN and 0PN (faded).
  11. kHigh-quality embryos on day 5—3BB or higher, no C’s (Gardner classification), no direct cleavage, no multinucleation on the four-cell stage or other abnormality.
  12. lThose with no embryos cryopreserved are included in the median.
  13. D2, day 2 after insemination; D5, day 5 after insemination; DET, double embryo transfers; EUR, embryo utilization rate.
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