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Addendum to Clinical Guideline 156, Fertility problems: assessment and treatment. London: National Institute for Health and Care Excellence (NICE); 2016 Aug. (NICE Guideline Addendum, No. 156.1.)
Addendum to Clinical Guideline 156, Fertility problems: assessment and treatment.
Show detailsTable 12Grade profile for IUI without ovarian stimulation versus expectant management
| Quality assessment | No of patients | Effect | Quality | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | IUI | Expectant management | Relative (95% CI) | Absolute | |
| Live birth (all) | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | very serious3 | serious4 | none |
43/191 (22.5%) |
32/193 (16.6%) | RR 1.36 (0.9 to 2.05) | 60 more per 1000 (from 17 fewer to 174 more) | VERY LOW |
| Live birth (unexplained infertility) | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | very serious3,5 | serious4 | none |
38/165 (23%) |
26/167 (15.6%) | RR 1.48 (0.94 to 2.32) | 75 more per 1000 (from 9 fewer to 206 more) | VERY LOW |
| Live birth (mild male factor) | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | very serious3,5 | very serious6 | none |
2/14 (14.3%) |
2/9 (22.2%) | RR 0.64 (0.11 to 3.78) | 80 fewer per 1000 (from 198 fewer to 618 more) | VERY LOW |
| Live birth (mild endometriosis) | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | very serious3,5 | very serious6 | none |
3/13 (23.1%) |
4/17 (23.5%) | RR 0.98 (0.26 to 3.64) | 5 fewer per 1000 (from 174 fewer to 621 more) | VERY LOW |
| Live birth - Live birth (mild endometriosis and mild male factor) | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | very serious3,5 | no serious imprecision7 | none |
0/1 (0%) | NC | NC | NC | VERY LOW |
| Pregnancy rate - Pregnancy per woman (all) | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | serious4 | none |
43/191 (22.5%) |
33/193 (17.1%) | RR 1.32 (0.88 to 1.98) | 55 more per 1000 (from 21 fewer to 168 more) | VERY LOW |
| Pregnancy rate - multiple pregnancies per woman (all) | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | very serious6 | none |
1/191 (0.52%) |
2/193 (1%) | RR 0.51 (0.05 to 5.53) | 5 fewer per 1000 (from 10 fewer to 47 more) | VERY LOW |
| Pregnancy related adverse events - Miscarriage per pregnancy | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | serious4 | none |
9/55 (16.4%) |
14/46 (30.4%) | RR 0.54 (0.26 to 1.13) | 140 fewer per 1000 (from 225 fewer to 40 more) | VERY LOW |
| Pregnancy related adverse events - Ectopic pregnancy per pregnancy | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | very serious6 | none |
2/55 (3.6%) |
1/46 (2.2%) | RR 1.67 (0.16 to 17.86) | 15 more per 1000 (from 18 fewer to 367 more) | VERY LOW |
| Pregnancy related adverse events - Preterm birth | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | very serious6 | none |
6/43 (14%) |
5/31 (16.1%) | RR 0.87 (0.29 to 2.58) | 21 fewer per 1000 (from 115 fewer to 255 more) | VERY LOW |
| Patient related adverse events - Treatment related hospital admissions | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | very serious6 | none |
0/163 (0%) |
2/160 (1.3%) | RR 0.2 (0.01 to 4.06) | 10 fewer per 1000 (from 12 fewer to 38 more) | VERY LOW |
| Patient related adverse events - Abdominal pain | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | serious4 | none |
12/164 (7.3%) |
5/159 (3.1%) | RR 2.33 (0.84 to 6.45) | 42 more per 1000 (from 5 fewer to 171 more) | VERY LOW |
| Patient related adverse events - Vaginal bleeding | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | serious4 | none |
10/164 (6.1%) |
4/159 (2.5%) | RR 2.42 (0.78 to 7.57) | 36 more per 1000 (from 6 fewer to 165 more) | VERY LOW |
| Patient related adverse events - Nausea | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | very serious6 | none |
3/164 (1.8%) |
0/158 (0%) | RR 0 (0.35 to 129.55) | NC | VERY LOW |
| Patient related adverse events - Hot flushes | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | very serious6 | none |
0/164 (0%) |
4/159 (2.5%) | RR 0.11 (0.01 to 1.99) | 22 fewer per 1000 (from 25 fewer to 25 more) | VERY LOW |
| Patient related adverse events - Bloating | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | very serious6 | none |
6/164 (3.7%) |
0/158 (0%) | RR 12.53 (0.71 to 220.54) | NC | VERY LOW |
| Patient related adverse events - total | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | serious4 | none |
31/164 (18.9%) |
15/159 (9.4%) | RR 2 (1.13 to 3.57) | 94 more per 1000 (from 12 more to 242 more) | VERY LOW |
| Patient satisfaction - Process of treatment acceptable | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | serious4 | none |
155/162 (95.7%) |
123/153 (80.4%) | RR 1.19 (1.09 to 1.3) | 153 more per 1000 (from 72 more to 241 more) | VERY LOW |
| Patient satisfaction - Outcome of treatment acceptable | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | serious4 | none |
117/159 (73.6%) |
82/148 (55.4%) | RR 1.33 (1.12 to 1.58) | 183 more per 1000 (from 66 more to 321 more) | VERY LOW |
| Anxiety | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | no serious imprecision8 | none |
22/173 (12.7%) |
3/171 (1.8%) | RR 7.25 (2.21 to 23.77) | 110 more per 1000 (from 21 more to 399 more) | LOW |
| Depression | |||||||||||
| 1(Bhattacharya 2008) | RCT | serious1 | no serious inconsistency2 | serious5 | very serious6 | none |
2/172 (1.2%) |
4/170 (2.4%) | RR 0.49 (0.09 to 2.66) | 12 fewer per 1000 (from 21 fewer to 39 more) | VERY LOW |
- 1
Evidence was downgraded by 1 as blinding was not possible.
- 2
Inconsistency not applicable as no meta-analysis was conducted (outcome is from a single study).
- 3
Evidence was downgraded by 1 as the outcome ‘live birth’ is indirect for ‘live singleton birth’.
- 4
Evidence was downgraded by 1 due to 95% CI crossing one MID.
- 5
Evidence was downgraded by 1 due to indirectness of treatment as 17% of women allocated to IUI (n = 33) received expectant management and 3% of women in the EM group (n = 6) received IUI.
- 6
Evidence was downgraded by 2 as 95% CIs crossed two MIDs.
- 7
Effect estimate and 95% CIs not calculable.
- 8
No serious imprecision as 95% CIs do not cross MIDs.
Table 13GRADE table for IUI with ovarian stimulation versus expectant management
| Quality assessment | No of patients | Effect | Quality Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | IUI with stimulation | Expectant management | Relative (95% CI) | Absolute | |
| Live births (determined by interview, cumulative number after up to 4 cycles) | |||||||||||
| 1(Tummon 1997) | RCT | serious1 | no serious inconsistency2 | serious3 | serious4 | none |
14/53 (26.4%) |
4/50 (8%) | RR 3.3 (1.16 to 9.36) | 184 more per 1000 (from 13 more to 669 more) | VERY LOW |
| Live singleton births (number of live births - multiple births) | |||||||||||
| 1(Tummon 1997) | RCT | serious1 | no serious inconsistency2 | no serious indirectness5 | serious4 | none |
11/53 (20.8%) |
4/50 (8%) | RR 2.59 (0.88 to 7.62) | 127 more per 1000 (from 10 fewer to 530 more) | LOW |
| Live multiple births (determined by interview, cumulative number after up to 4 cycles) | |||||||||||
| 1(Tummon 1997) | RCT | serious1 | no serious inconsistency2 | serious3 | very serious | none |
3/53 (5.7%) |
0/50 (0%) | RR 6.61 (0.35 to 124.85) | NC | VERY LOW |
| Live births | |||||||||||
| 1(Steures 2006) | RCT | serious1 | no serious inconsistency2 | serious3 | very serious6 | none |
26/127 (20.5%) |
30/126 (24.6%) | RR 0.86 (0.54 to 1.37) | 34 fewer per 1000 (from 113 fewer to 91 more) | VERY LOW |
| Ovarian hyperstimulation syndrome | |||||||||||
| 1(Tummon 1997) | RCT | serious1 | no serious inconsistency2 | no serious indirectness5 | no serious imprecision7 | none |
0/53 (0%) |
0/50 (0%) | NC | NC | MODERATE |
| Pregnancy rates - Pregnancy (ongoing), 6 months | |||||||||||
| 1(Steures 2006) | RCT | serious1 | no serious inconsistency2 | very serious8,9 | very serious6 | none |
29/127 (22.8%) |
34/126 (23.8%) | RR 00.85 (0.55 to 1.30) | 40 fewer per 1000 (from 121 fewer to 81 more) | VERY LOW |
| Pregnancy rates - Multiple pregnancies, 6 months | |||||||||||
| 1(Steures 2006) | RCT | serious1 | no serious inconsistency2 | serious8 | very serious6 | none |
2/127 (1.6%) |
1/126 (0.79%) | RR 1.98 (0.18 to 21.61) | 8 fewer per 1000 (from 7 fewer to 164 more) | VERY LOW |
| Pregnancy related adverse events - Miscarriage, 6 months | |||||||||||
| 1(Steures 2006) | RCT | serious1 | no serious inconsistency2 | serious8 | serious4 | none |
13/42 (31%) |
6/40 (15%) | RR 2.06 (0.87 to 4.9) | 159 more per 1000 (from 20 fewer to 585 more) | VERY LOW |
- 1
Evidence was downgraded by 1 as blinding was not reported.
- 2
Inconsistency not applicable as no meta-analysis was conducted (outcome is from a single study).
- 3
Evidence was downgraded by 1 as the outcome ‘live birth’ is indirect for ‘live singleton birth’.
- 4
Evidence was downgraded by 1 as 95% CIs crossed one MID.
- 5
No serious indirectness as population, intervention and outcome is in agreement with review protocol.
- 6
Evidence was downgraded by 2 as 95% CIs crossed two MIDs.
- 7
No serious imprecision as 95% CI do not cross MIDs.
- 8
Evidence was downgraded by 1 due to indirect assessment of infertility in 31 (24%) women assigned to the intervention group and in 32 (25%) assigned to expectant management group as tubal function had not been assessed by hysterosalpingography or laparoscopy before randomisation.
- 9
Evidence was downgraded by 1 due to indirect treatment: 25 couples in expectant management group started IUI during trial duration (6 months).
Table 14GRADE table for IUI with ovarian stimulation versus IUI without ovarian stimulation
| Quality assessment | No of patients | Effect | Quality | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | IUI with stimulation | IUI without stimulation | Relative (95% CI) | Absolute | |
| Live singleton birth | |||||||||||
| 1(Goverde 2005) | RCT | serious1 | no serious inconsistency2 | no serious indirectness | very serious3 | none |
22/85 (25.9%) |
25/86 (29.1%) | RR 0.89 (0.55 to 1.45) | 32 fewer per 1000 (from 131 fewer to 131 more) | VERY LOW |
| Live births | |||||||||||
| 2(Goverde 2005, Guzick 1999) | RCT | serious1 | no serious inconsistency4 | serious5 | serious6 | none |
72/316 (22.8%) |
53/320 (16.6%) | RR 1.38 (1.01 to 1.88) | 63 more per 1000 (from 2 more to 146 more) | VERY LOW |
| Pregnancy rate per IUI cycle | |||||||||||
| 1(Cohlen 1998) | RCT | serious1 | no serious inconsistency2 | no serious indirectness7 | very serious3 | none |
3/36 (8.3%) |
4/38 (10.5%) | RR 0.79 (0.19 to 3.29) | 22 fewer per 1000 (from 85 fewer to 241 more) | VERY LOW |
| Pregnancy rate per couple | |||||||||||
| 1(Guzick 1999) | RCT | serious1 | no serious inconsistency2 | no serious indirectness7 | no serious imprecision8 | none |
77/231 (33.3%) |
42/234 (17.9%) | RR 1.86 (1.34 to 2.58) | 154 more per 1000 (from 61 more to 284 more) | MODERATE |
| Pregnancy rates - Ongoing pregnancy | |||||||||||
| 1(Goverde 2005) | RCT | serious1 | no serious inconsistency2 | no serious indirectness7 | serious6 | none |
33/85 (38.8%) |
28/86 (32.6%) | RR 1.19 (0.8 to 1.79) | 62 more per 1000 (from 65 fewer to 257 more) | LOW |
| Pregnancy rates - Singleton pregnancy | |||||||||||
| 1(Goverde 2005) | RCT | serious1 | no serious inconsistency2 | no serious indirectness7 | very serious3 | none |
24/85 (28.2%) |
27/86 (31.4%) | RR 0.9 (0.57 to 1.43) | 31 fewer per 1000 (from 135 fewer to 135 more) | VERY LOW |
| Pregnancy rates - Multiple pregnancies | |||||||||||
| 2(Goverde 2005, Guzick 1999) | RCT | serious1 | no serious inconsistency4 | no serious indirectness7 | no serious imprecision8 | none |
14/316 (4.4%) |
1/320 (0.31%) | RR 9.78 (1.84 to 51.91) | 27 more per 1000 (from 3 more to 159 more) | MODERATE |
| Pregnancy related adverse events - Preterm birth | |||||||||||
| 1(Guzick 1999) | RCT | serious1 | no serious inconsistency2 | no serious indirectness7 | serious6 | none |
9/231 (3.9%) |
2/234 (0.85%) | RR 4.56 (1 to 20.87) | 30 more per 1000 (from 0 more to 170 more) | LOW |
| Pregnancy related adverse events - Stillbirth | |||||||||||
| 1(Guzick 1999) | RCT | serious1 | no serious inconsistency2 | no serious indirectness7 | very serious3 | none |
0/231 (0%) |
1/234 (0.43%) | RR 0.34 (0.01 to 8.25) | 3 fewer per 1000 (from 4 fewer to 31 more) | VERY LOW |
| Pregnancy related adverse events - Ectopic | |||||||||||
| 1(Guzick 1999) | RCT | serious1 | no serious inconsistency2 | no serious indirectness7 | very serious3 | none |
4/231 (1.7%) |
2/234 (0.85%) | RR 2.02 (0.37 to 10.95) | 9 more per 1000 (from 5 fewer to 85 more) | VERY LOW |
| Pregnancy related adverse events - Miscarriage | |||||||||||
| 1(Guzick 1999) | RCT | serious1 | no serious inconsistency2 | no serious indirectness7 | no serious imprecision8 | none |
22/231 (9.5%) |
6/234 (2.6%) | RR 3.71 (1.57 to 8.99) | 69 more per 1000 (from 15 more to 205 more) | MODERATE |
| Pregnancy related adverse events - Induced abortion | |||||||||||
| 1(Guzick 1999) | RCT | serious1 | no serious inconsistency2 | no serious indirectness7 | very serious3 | none |
0/231 (0%) |
1/234 (0.43%) | RR 0.34 (0.01 to 8.25) | 3 fewer per 1000 (from 4 fewer to 31 more) | VERY LOW |
| Pregnancy related adverse events - Total | |||||||||||
| 1(Guzick 1999) | RCT | serious1 | no serious inconsistency2 | no serious indirectness7 | no serious imprecision | none |
35/231 (15.2%) |
12/234 (5.1%) | RR 2.95 (1.57 to 5.55) | 100 more per 1000 (from 29 more to 233 more) | MODERATE |
- 1
Evidence was downgraded by 1 as blinding was not reported.
- 2
Inconsistency not applicable as no meta-analysis was conducted (outcome is from a single study).
- 3
Evidence was downgraded by 2 as 95% CIs crossed two MIDs.
- 4
No serious inconsistency as heterogeneity measure (I squared) < 50%.
- 5
Evidence was downgraded by 1 as the outcome ‘live birth’ is indirect for ‘live singleton birth’.
- 6
Evidence was downgraded by 1 as 95% CIs crossed one MID.
- 7
No serious indirectness as population, intervention and outcome is in agreement with review protocol.
- 8
No serious imprecision as 95% CIs do not cross MIDs.
- GRADE profiles - Addendum to Clinical Guideline 156, Fertility problems: assessm...GRADE profiles - Addendum to Clinical Guideline 156, Fertility problems: assessment and treatment
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