Table 4 Sensitivity analysis showing crude number of reproductive outcomes expressed as N (%;95%CI) in the respective groups under modified intention to treat (mITT) criteria and with deferred vaginal swab diagnosis from the time of randomisation

From: Efficacy of clindamycin and LACTIN-V for in vitro fertilization patients with vaginal dysbiosis: a randomised double-blind, placebo-controlled multicentre trial

 

HCG positives

Clinical pregnancy week 7–9

Ongoing pregnancy week 10–12

Early pregnancy loss

Live birth

AVM positive (CLLA, N = 72)

44 (61%;50–72%)

32 (44%;33–56%)

31 (43%;32–55%)

13 (29%; 16–43%)

30 (42%;30–53%)

AVM positive (CLPL, N = 64)

40 (63%;51–74%)

26 (41%;29–53%)

26 (41%;29–53%)

14 (35%; 20–50%)

26 (41%;29–53%)

AVM positive (PLPL, N = 68)

41 (60%;49–72%)

31 (46%;34–57%)

31 (46%;34–57%)

10 (24%;11–38%)

30 (44%;32–56%)

AVM negative (CLLA, N = 20)

12 (60%;38–82%)

7 (35%;14–56%)

7 (35%;14–56%)

5 (41%)

7 (35%)

AVM negative (CLPL, N = 23)

17 (74%;56–92%)

14 (61%;41–81%)

13 (57%;36–77%)

4 (24%)

13 (57%)

AVM negative (PLPL, N = 14)

9 (64%;39–89%)

7 (50%;24–76%)

6 (43%;17–69%)

3 (33%)

4 (28%)

CST I + II + III + V (CLLA, N = 14)

9 (64%;39–89%)

7 (50%; 24–76%)

7 (50%; 24–76%)

2 (22%)

7 (50%; 24–76%)

CST I + II + III + V (CLPL, N = 14)

10 (71%;48–95%)

8 57%; 31–83%)

8 57%; 31–83%)

2 (20%)

8 (57%; 31–83%)

CST I + II + III + V (PLPL, N = 14)

11 (79%;57–100%)

9 (64%; 39–89%)

9 (64%; 39–89%)

2 (18%)

7 (50%; 24–76%)

CST IV-A + B (CLLA, N = 67)

41 (61%;49–73%)

29 (43%; 31–55%)

28 (42%; 30–54%)

13 (32%; 17–46%)

27 (40%; 29–52%)

CST IV-A + B (CLPL, N = 61)

38 (62%;50–75%)

25 (41%;29–53%)

24 (39%; 27–52%)

14 (37%; 21–52%)

24 (39%; 27–52%)

CST IV-A + B (PLPL, N = 55)

31 (56%;43–70%)

23 (42%;29–55%)

23 (42%; 29–55%)

8 (26%; 10–41%)

22 (40%; 27–53%)

CST IV-C (CLLA, N = 5)

3 (60%)

1 (20%)

1 (20%)

2 (66%)

1 (20%)

CST IV-C (CLPL, N = 7)

6 (86%)

5 (71%)

5 (71%)

1 (17%)

5 (71%)

CST IV-C (PLPL, N = 8)

7 (88%)

5 (63%)

4 (50%)

3 (43%)

4 (50%)

  1. Crude number of N outcome and (%;95%CI) where possible for all patients with a vaginal swab positive for the indexed group at the time of randomisation and according to mITT conditions. CST Community state type by VALENCIA classification5, AVM abnormal vaginal microbiota by qPCR. For comparisons where N outcome was less than 5, the 95%CI is not shown as data is very sparse and difficult to interpret.
Back to article page