13.8
12.6
10.7
10.3
Difference [95% CI]
2.5 [1.2; 3.9]
1.2 [0.5, 1.9]
0.5 [-0.2, 1.2]
Pregnancy from the fresh cycles of ENGAGE and PURSUE
In the ENGAGE study, non-inferiority was demonstrated in ongoing pregnancy rates between Elonva and recFSH, with ongoing pregnancy rate defined as presence of at least one foetus with heart activity assessed at least 10 weeks after embryo transfer.
In the PURSUE study, non-inferiority was demonstrated in vital pregnancy rate between Elonva and recFSH, with vital pregnancy rate defined as the percentage of subjects with at least one foetus with heart activity assessed 5 to 6 weeks after embryo transfer.
The pregnancy results from the fresh cycles of ENGAGE and PURSUE are summarized in Table 2 below.
Table 2: Pregnancy Results from the Fresh Cycles of ENGAGE and PURSUE
Intent-to-Treat Population (ITT)
Parameter
Fresh Cycles of ENGAGE†
(18-36 years of age)
(body weight greater than 60 kg and less than or equal to 90 kg)
Fresh Cycles of PURSUE‡
(35-42 years of age)
(body weight greater than or equal to 50 kg)
Elonva
150 µg
recFSH
200 IU
Difference
[95% CI]
Elonva
150 µg
recFSH
300 IU
Difference
[95% CI]
N=756
N=750
N=694
N=696
Vital pregnancy rate
39.9%
39.1%
1.1 [-3.8, 5.9]
23.9%
26.9%
-3.0 [-7.3, 1.4]
Ongoing pregnancy rate
39.0%
38.1%
1.1 [-3.8, 5.9]
22.2%
24.0%
-1.9 [-6.1, 2.3]
Live birth rate*
35.6%
34.4%
1.3 [-3.5, 6.1]
21.3%
23.4%
-2.3 [-6.5, 1.9]
†The primary efficacy endpoint in the ENGAGE study was ongoing pregnancy (assessed at least 10 weeks after embryo transfer).
‡The primary efficacy endpoint in the PURSUE study was vital pregnancy rate defined as the percentage of subjects with at least one foetus with heart activity assessed 5 to 6 weeks after embryo transfer.
*Live birth rate was a secondary efficacy endpoint in ENGAGE and PURSUE.
In these clinical trials, the safety profile of a single injection with Elonva was comparable to daily injections with recFSH.
Pregnancy from the Frozen-Thawed Embryo Transfer (FTET) cycles of ENGAGE and PURSUE
The follow-up FTET trial for ENGAGE included women who had at least one embryo thawed for use up to at least one year after cryopreservation. The mean number of embryos transferred in the FTET cycles of ENGAGE was 1.7 in both treatment groups.
The follow-up FTET trial for PURSUE included women who had at least one embryo thawed for use within two years of the date of the last cryopreservation for this trial. The mean number of embryos transferred in the FTET cycles of PURSUE was 2.4 in both treatment groups. This trial also provided safety data on the infants born from cryopreserved embryos.
The maximum number of FTET cycles was 5 and 4 for the follow-up FTET trial for ENGAGE and PURSUE, respectively. The pregnancy results from the first two FTET cycles of ENGAGE and PURSUE are summarized in Table 3 below.
Table 3: Pregnancy Results from the FTET cycles of ENGAGE and PURSUE
Intent-to-Treat Population (ITT)
FTET Cycles of ENGAGE
(18-36 years of age)
(body weight greater than 60 kg and less than or equal to 90 kg)
FTET Cycles of PURSUE
(35-42 years of age)
(body weight greater than or equal to 50 kg)
Elonva
150 µg
recFSH
200 IU
Elonva
150 µg
recFSH
300 IU
n
N
%
n
N
|
