Significantly more live births were achieved through spontaneous pregnancies in the weight reduction and IVF group than in the IVF only group, 10.5% (16) as compared to 2.6% (4) (difference 7.9, 95% CI: 14.1–1.8, P = 0.009) (Table II). No difference between the groups occurred concerning treatments with IVF or ICSI. The PP analysis showed similar results and with no significant difference in live birth rates and more spontaneous pregnancies resulting in live births in the weight reduction group (Supplementary Table S1).

Table II

Outcomes according to treatment group in the full analysis set.

VariableWeight reduction and IVF group (n = 152)IVF only group (n = 153)P-value
Spontaneous pregnancy leading to live birth¤16 (10.5%)4 (2.6%)0.0089
No. of patients starting follitropin alfa stimulation136 (89.5%)149 (97.4%)<0.005
Cancelled cycle**3 (2.2%)9 (6.0%)0.19
Total dose of follitropin alfa (IU)2122 (855)2184 (1034)0.89
1886 (925; 5550)1850 (859; 6000)
n = 136n = 149
Follitropin alfa (IU) required per oocyte retrieved434.9 (629.5)411.2 (444.7)0.91
265.4 (44.9; 5550.0)262.1 (41.0; 2850.0)
n = 133n = 139
No. of oocytes retrieved per patient8.56 (5.28)9.00 (5.85)0.63
7.00 (1.00; 25.00)8.00 (0.00; 32.00)
n = 133n = 140
Moderate or severe ovarian hyperstimulation syndrome5 (3.8%)7 (5.0%)0.74
No. of oocytes fertilized***4.35 (3.78)4.76 (3.63)0.24
4.00 (0.00; 21.00)4.00 (0.00; 17.00)
n = 133n = 139
Rate of fertilization=0.51 (0.30)0.54 (0.27)0.40
0.53 (0.000; 1.000)0.57 (0.000; 1.000)
n = 133n = 139
No. of good quality embryos* Day 22.43 (2.57)2.64 (2.59)0.51
2.00 (0.00; 14.00)2.00 (0.00; 12.00)
n = 131n = 137
No. of frozen embryos1.32 (1.66)1.64 (2.56)0.84
1.00 (0.00; 8.00)1.00 (0.00; 15.00)
n = 127n = 133
No. of transferred embryos
 024 (18.6%)16 (11.6%)
 194 (72.9%)110 (79.7%)
 211 (8.5%)12 (8.7%)0.22
Embryo transfer performed105 (77.2%)122 (81.9%)0.46
No. of good quality embryos* transferred
 017 (16.2%)20 (16.4%)
 182 (78.1%)96 (78.7%)
 26 (5.7%)6 (4.9%)0.87
Day of embryo transfer
 295 (90.5%)109 (89.3%)
 38 (7.6%)8 (6.6%)
 52 (1.9%)5 (4.1%)0.47
Clinical pregnancy##53 (34.9%)47 (30.7%)0.52
Ectopic pregnancy###1/66 (1.5%)1/56 (1.8%)
Biochemical pregnancy####12/66 (18.2%)8/56 (14.3%)
Miscarriage gestational weeks 6–128/66 (12.1%)4/56 (7.1%)
Miscarriage gestational weeks 13–220 (0.0%)1/56 (1.8%)
Live birth (including spontaneous pregnancies)45 (29.6%)42 (27.5%)0.77
Singleton births45 (100.0%)41 (97.6%)
Twin births0 (0.0%)1 (2.4%)1.00
VariableWeight reduction and IVF group (n = 152)IVF only group (n = 153)P-value
Spontaneous pregnancy leading to live birth¤16 (10.5%)4 (2.6%)0.0089
No. of patients starting follitropin alfa stimulation136 (89.5%)149 (97.4%)<0.005
Cancelled cycle**3 (2.2%)9 (6.0%)0.19
Total dose of follitropin alfa (IU)2122 (855)2184 (1034)0.89
1886 (925; 5550)1850 (859; 6000)
n = 136n = 149
Follitropin alfa (IU) required per oocyte retrieved434.9 (629.5)411.2 (444.7)0.91
265.4 (44.9; 5550.0)262.1 (41.0; 2850.0)
n = 133n = 139
No. of oocytes retrieved per patient8.56 (5.28)9.00 (5.85)0.63
7.00 (1.00; 25.00)8.00 (0.00; 32.00)
n = 133n = 140
Moderate or severe ovarian hyperstimulation syndrome5 (3.8%)7 (5.0%)0.74
No. of oocytes fertilized***4.35 (3.78)4.76 (3.63)0.24
4.00 (0.00; 21.00)4.00 (0.00; 17.00)
n = 133n = 139
Rate of fertilization=0.51 (0.30)0.54 (0.27)0.40
0.53 (0.000; 1.000)0.57 (0.000; 1.000)
n = 133n = 139
No. of good quality embryos* Day 22.43 (2.57)2.64 (2.59)0.51
2.00 (0.00; 14.00)2.00 (0.00; 12.00)
n = 131n = 137
No. of frozen embryos1.32 (1.66)1.64 (2.56)0.84
1.00 (0.00; 8.00)1.00 (0.00; 15.00)
n = 127n = 133
No. of transferred embryos
 024 (18.6%)16 (11.6%)
 194 (72.9%)110 (79.7%)
 211 (8.5%)12 (8.7%)0.22
Embryo transfer performed105 (77.2%)122 (81.9%)0.46
No. of good quality embryos* transferred
 017 (16.2%)20 (16.4%)
 182 (78.1%)96 (78.7%)
 26 (5.7%)6 (4.9%)0.87
Day of embryo transfer
 295 (90.5%)109 (89.3%)
 38 (7.6%)8 (6.6%)
 52 (1.9%)5 (4.1%)0.47
Clinical pregnancy##53 (34.9%)47 (30.7%)0.52
Ectopic pregnancy###1/66 (1.5%)1/56 (1.8%)
Biochemical pregnancy####12/66 (18.2%)8/56 (14.3%)
Miscarriage gestational weeks 6–128/66 (12.1%)4/56 (7.1%)
Miscarriage gestational weeks 13–220 (0.0%)1/56 (1.8%)
Live birth (including spontaneous pregnancies)45 (29.6%)42 (27.5%)0.77
Singleton births45 (100.0%)41 (97.6%)
Twin births0 (0.0%)1 (2.4%)1.00

For categorical variables n (%) is presented.

For continuous variables mean (SD)/median (min; max)/n = is presented.

For comparison between groups Fisher's Exact test (lowest 1-sided P-value multiplied by 2) was used for dichotomous variables and the Mantel–Haenszel chi square test was used for ordered categorical variables and chi square test was used for non-ordered categorical variables and the Mann–Whitney U-test was used for continuous variables.

Calculation of CI for continuous variables is based on the assumption of normality. When variances are not equal (P < 0.05) the SD is based on Satterthwaite's approximation, otherwise the SD is based on the pooled SDs.

*Day 2; 4–5 blastomeres, <20% fragmentation and no multinucleated blastomeres

**After starting the stimulation with follitrophin alfa.

***Defined as when two pronuclei were visible Day 1 after fertilization.

=No. of two pronuclei/no. of oocytes retrieved.

¤Pregnancy occurring without assisted reproduction technique treatment.

##Amniotic sac, with or without fetus, observed at sonography in gestational week 7.

###Pregnancy located outside the uterine cavity.

####Human chorion gonadotrophin in serum >5 IE/L but no amniotic sac visible at sonography gestational week 7.

Table II

Outcomes according to treatment group in the full analysis set.

VariableWeight reduction and IVF group (n = 152)IVF only group (n = 153)P-value
Spontaneous pregnancy leading to live birth¤16 (10.5%)4 (2.6%)0.0089
No. of patients starting follitropin alfa stimulation136 (89.5%)149 (97.4%)<0.005
Cancelled cycle**3 (2.2%)9 (6.0%)0.19
Total dose of follitropin alfa (IU)2122 (855)2184 (1034)0.89
1886 (925; 5550)1850 (859; 6000)
n = 136n = 149
Follitropin alfa (IU) required per oocyte retrieved434.9 (629.5)411.2 (444.7)0.91
265.4 (44.9; 5550.0)262.1 (41.0; 2850.0)
n = 133n = 139
No. of oocytes retrieved per patient8.56 (5.28)9.00 (5.85)0.63
7.00 (1.00; 25.00)8.00 (0.00; 32.00)
n = 133n = 140
Moderate or severe ovarian hyperstimulation syndrome5 (3.8%)7 (5.0%)0.74
No. of oocytes fertilized***4.35 (3.78)4.76 (3.63)0.24
4.00 (0.00; 21.00)4.00 (0.00; 17.00)
n = 133n = 139
Rate of fertilization=0.51 (0.30)0.54 (0.27)0.40
0.53 (0.000; 1.000)0.57 (0.000; 1.000)
n = 133n = 139
No. of good quality embryos* Day 22.43 (2.57)2.64 (2.59)0.51
2.00 (0.00; 14.00)2.00 (0.00; 12.00)
n = 131n = 137
No. of frozen embryos1.32 (1.66)1.64 (2.56)0.84
1.00 (0.00; 8.00)1.00 (0.00; 15.00)
n = 127n = 133
No. of transferred embryos
 024 (18.6%)16 (11.6%)
 194 (72.9%)110 (79.7%)
 211 (8.5%)12 (8.7%)0.22
Embryo transfer performed105 (77.2%)122 (81.9%)0.46
No. of good quality embryos* transferred
 017 (16.2%)20 (16.4%)
 182 (78.1%)96 (78.7%)
 26 (5.7%)6 (4.9%)0.87
Day of embryo transfer
 295 (90.5%)109 (89.3%)
 38 (7.6%)8 (6.6%)
 52 (1.9%)5 (4.1%)0.47
Clinical pregnancy##53 (34.9%)47 (30.7%)0.52
Ectopic pregnancy###1/66 (1.5%)1/56 (1.8%)
Biochemical pregnancy####12/66 (18.2%)8/56 (14.3%)
Miscarriage gestational weeks 6–128/66 (12.1%)4/56 (7.1%)
Miscarriage gestational weeks 13–220 (0.0%)1/56 (1.8%)
Live birth (including spontaneous pregnancies)45 (29.6%)42 (27.5%)0.77
Singleton births45 (100.0%)41 (97.6%)
Twin births0 (0.0%)1 (2.4%)1.00
VariableWeight reduction and IVF group (n = 152)IVF only group (n = 153)P-value
Spontaneous pregnancy leading to live birth¤16 (10.5%)4 (2.6%)0.0089
No. of patients starting follitropin alfa stimulation136 (89.5%)149 (97.4%)<0.005
Cancelled cycle**3 (2.2%)9 (6.0%)0.19
Total dose of follitropin alfa (IU)2122 (855)2184 (1034)0.89
1886 (925; 5550)1850 (859; 6000)
n = 136n = 149
Follitropin alfa (IU) required per oocyte retrieved434.9 (629.5)411.2 (444.7)0.91
265.4 (44.9; 5550.0)262.1 (41.0; 2850.0)
n = 133n = 139
No. of oocytes retrieved per patient8.56 (5.28)9.00 (5.85)0.63
7.00 (1.00; 25.00)8.00 (0.00; 32.00)
n = 133n = 140
Moderate or severe ovarian hyperstimulation syndrome5 (3.8%)7 (5.0%)0.74
No. of oocytes fertilized***4.35 (3.78)4.76 (3.63)0.24
4.00 (0.00; 21.00)4.00 (0.00; 17.00)
n = 133n = 139
Rate of fertilization=0.51 (0.30)0.54 (0.27)0.40
0.53 (0.000; 1.000)0.57 (0.000; 1.000)
n = 133n = 139
No. of good quality embryos* Day 22.43 (2.57)2.64 (2.59)0.51
2.00 (0.00; 14.00)2.00 (0.00; 12.00)
n = 131n = 137
No. of frozen embryos1.32 (1.66)1.64 (2.56)0.84
1.00 (0.00; 8.00)1.00 (0.00; 15.00)
n = 127n = 133
No. of transferred embryos
 024 (18.6%)16 (11.6%)
 194 (72.9%)110 (79.7%)
 211 (8.5%)12 (8.7%)0.22
Embryo transfer performed105 (77.2%)122 (81.9%)0.46
No. of good quality embryos* transferred
 017 (16.2%)20 (16.4%)
 182 (78.1%)96 (78.7%)
 26 (5.7%)6 (4.9%)0.87
Day of embryo transfer
 295 (90.5%)109 (89.3%)
 38 (7.6%)8 (6.6%)
 52 (1.9%)5 (4.1%)0.47
Clinical pregnancy##53 (34.9%)47 (30.7%)0.52
Ectopic pregnancy###1/66 (1.5%)1/56 (1.8%)
Biochemical pregnancy####12/66 (18.2%)8/56 (14.3%)
Miscarriage gestational weeks 6–128/66 (12.1%)4/56 (7.1%)
Miscarriage gestational weeks 13–220 (0.0%)1/56 (1.8%)
Live birth (including spontaneous pregnancies)45 (29.6%)42 (27.5%)0.77
Singleton births45 (100.0%)41 (97.6%)
Twin births0 (0.0%)1 (2.4%)1.00

For categorical variables n (%) is presented.

For continuous variables mean (SD)/median (min; max)/n = is presented.

For comparison between groups Fisher's Exact test (lowest 1-sided P-value multiplied by 2) was used for dichotomous variables and the Mantel–Haenszel chi square test was used for ordered categorical variables and chi square test was used for non-ordered categorical variables and the Mann–Whitney U-test was used for continuous variables.

Calculation of CI for continuous variables is based on the assumption of normality. When variances are not equal (P < 0.05) the SD is based on Satterthwaite's approximation, otherwise the SD is based on the pooled SDs.

*Day 2; 4–5 blastomeres, <20% fragmentation and no multinucleated blastomeres

**After starting the stimulation with follitrophin alfa.

***Defined as when two pronuclei were visible Day 1 after fertilization.

=No. of two pronuclei/no. of oocytes retrieved.

¤Pregnancy occurring without assisted reproduction technique treatment.

##Amniotic sac, with or without fetus, observed at sonography in gestational week 7.

###Pregnancy located outside the uterine cavity.

####Human chorion gonadotrophin in serum >5 IE/L but no amniotic sac visible at sonography gestational week 7.

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