Trial Outcomes & Findings for AS900672-Enriched in Ovulation Induction (NCT NCT00553514)
NCT ID: NCT00553514
Last Updated: 2014-02-13
Results Overview
Ovulation was defined as a mid-luteal phase progesterone (P4) level \>= 30 nanomole per liter (nmol/L) (10 nanogram per milliliter \[ng/mL\]). In the absence of a positive progesterone response, clinical pregnancy was also considered as evidence of ovulation.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
Mid-luteal phase progesterone assessed 5-10 days or clinical pregnancy 35-42 days after recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 14 days])
Results posted on
2014-02-13
Participant Flow
Participant milestones
| Measure |
AS900672-Enriched 10 Mcg
Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 20 Mcg
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 30 Mcg
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 40 Mcg
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
Follitropin Alfa 75 IU
Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
15
|
13
|
15
|
|
Overall Study
COMPLETED
|
6
|
6
|
9
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
6
|
7
|
7
|
Reasons for withdrawal
| Measure |
AS900672-Enriched 10 Mcg
Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 20 Mcg
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 30 Mcg
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 40 Mcg
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
Follitropin Alfa 75 IU
Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
|---|---|---|---|---|---|
|
Overall Study
Protocol deviation
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of ovarian response
|
4
|
5
|
5
|
5
|
6
|
|
Overall Study
Ovarian hyperstimulation syndrome risk
|
3
|
0
|
1
|
0
|
0
|
|
Overall Study
Risk of multiple pregnancy
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
Other
|
1
|
1
|
0
|
0
|
1
|
Baseline Characteristics
AS900672-Enriched in Ovulation Induction
Baseline characteristics by cohort
| Measure |
AS900672-Enriched 10 Mcg
n=14 Participants
Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 20 Mcg
n=14 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 30 Mcg
n=15 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 40 Mcg
n=13 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
Follitropin Alfa 75 IU
n=15 Participants
Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.5 years
n=5 Participants
|
31.5 years
n=7 Participants
|
28.0 years
n=5 Participants
|
30.0 years
n=4 Participants
|
30.0 years
n=21 Participants
|
30 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
71 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Mid-luteal phase progesterone assessed 5-10 days or clinical pregnancy 35-42 days after recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 14 days])Population: Per Protocol (PP) population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
Ovulation was defined as a mid-luteal phase progesterone (P4) level \>= 30 nanomole per liter (nmol/L) (10 nanogram per milliliter \[ng/mL\]). In the absence of a positive progesterone response, clinical pregnancy was also considered as evidence of ovulation.
Outcome measures
| Measure |
AS900672-Enriched 10 Mcg
n=13 Participants
Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 20 Mcg
n=13 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 30 Mcg
n=13 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 40 Mcg
n=12 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
Follitropin Alfa 75 IU
n=13 Participants
Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Ovulation
|
46.2 Percentage of participants
|
46.2 Percentage of participants
|
38.5 Percentage of participants
|
33.3 Percentage of participants
|
53.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])Population: PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.
Outcome measures
| Measure |
AS900672-Enriched 10 Mcg
n=13 Participants
Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 20 Mcg
n=13 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 30 Mcg
n=13 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 40 Mcg
n=12 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
Follitropin Alfa 75 IU
n=13 Participants
Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Pregnancy
|
23.1 Percentage of participants
|
0.0 Percentage of participants
|
7.7 Percentage of participants
|
16.7 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])Population: PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
Ovarian stimulation included from first dose of study drug on S1 until day on which r-hCG was administered (r-hCG day).
Outcome measures
| Measure |
AS900672-Enriched 10 Mcg
n=13 Participants
Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 20 Mcg
n=13 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 30 Mcg
n=13 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 40 Mcg
n=12 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
Follitropin Alfa 75 IU
n=13 Participants
Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
|---|---|---|---|---|---|
|
Duration of Ovarian Stimulation
|
10.0 Days
Standard Deviation 5.3
|
11.8 Days
Standard Deviation 3.4
|
14.0 Days
Standard Deviation 1.4
|
10.8 Days
Standard Deviation 3.7
|
10.6 Days
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])Population: PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
Outcome measures
| Measure |
AS900672-Enriched 10 Mcg
n=10 Participants
Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 20 Mcg
n=12 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 30 Mcg
n=13 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 40 Mcg
n=11 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
Follitropin Alfa 75 IU
n=11 Participants
Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
|---|---|---|---|---|---|
|
Duration of Supplemental Follitropin Alfa Treatment
|
6.6 Days
Standard Deviation 1.4
|
6.6 Days
Standard Deviation 1.4
|
7.7 Days
Standard Deviation 1.5
|
5.6 Days
Standard Deviation 2.2
|
5.5 Days
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])Population: PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
Outcome measures
| Measure |
AS900672-Enriched 10 Mcg
n=10 Participants
Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 20 Mcg
n=12 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 30 Mcg
n=13 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 40 Mcg
n=11 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
Follitropin Alfa 75 IU
n=10 Participants
Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
|---|---|---|---|---|---|
|
Cumulative Dose of Supplemental Follitropin Alfa Administered
|
476.3 IU
Standard Deviation 122.5
|
493.8 IU
Standard Deviation 108.3
|
556.7 IU
Standard Deviation 134.2
|
398.9 IU
Standard Deviation 167.9
|
397.5 IU
Standard Deviation 226.5
|
SECONDARY outcome
Timeframe: Stimulation Day 5 (S5), S7 and r-hCG administration day (end of stimulation cycle [approximately 14 days])Population: PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.
Outcome measures
| Measure |
AS900672-Enriched 10 Mcg
n=12 Participants
Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 20 Mcg
n=12 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 30 Mcg
n=13 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 40 Mcg
n=12 Participants
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
Follitropin Alfa 75 IU
n=13 Participants
Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
|---|---|---|---|---|---|
|
Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm
>= 11 mm on r-hCG Day (n=5,6,8,6,8)
|
2.6 Follicles
Standard Deviation 0.9
|
2.5 Follicles
Standard Deviation 1.9
|
2.5 Follicles
Standard Deviation 1.3
|
1.8 Follicles
Standard Deviation 0.8
|
2.9 Follicles
Standard Deviation 1.8
|
|
Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm
< 11 mm on S5 (n=12,12,12,12,13)
|
23.6 Follicles
Standard Deviation 13.8
|
28.7 Follicles
Standard Deviation 29.4
|
23.2 Follicles
Standard Deviation 6.7
|
20.9 Follicles
Standard Deviation 16.7
|
21.3 Follicles
Standard Deviation 13.7
|
|
Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm
< 11 mm on S7 (n=12,12,13,12,12)
|
22.8 Follicles
Standard Deviation 12.6
|
27.2 Follicles
Standard Deviation 30.9
|
21.0 Follicles
Standard Deviation 8.9
|
21.3 Follicles
Standard Deviation 17.3
|
22.0 Follicles
Standard Deviation 16.7
|
|
Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm
< 11 mm on r-hCG Day (n=5,6,7,6,7)
|
15.6 Follicles
Standard Deviation 7.3
|
11.7 Follicles
Standard Deviation 9.2
|
18.4 Follicles
Standard Deviation 12.1
|
18.7 Follicles
Standard Deviation 15.0
|
14.9 Follicles
Standard Deviation 12.4
|
|
Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm
>= 11 mm on S5 (n=12,8,7,11,8)
|
1.5 Follicles
Standard Deviation 2.2
|
0.0 Follicles
Standard Deviation 0.0
|
1.6 Follicles
Standard Deviation 1.9
|
2.8 Follicles
Standard Deviation 3.1
|
0.8 Follicles
Standard Deviation 0.9
|
|
Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm
>= 11 mm on S7 (n=11,9,7,11,11)
|
3.4 Follicles
Standard Deviation 6.2
|
0.2 Follicles
Standard Deviation 0.7
|
2.6 Follicles
Standard Deviation 3.5
|
2.8 Follicles
Standard Deviation 2.4
|
1.8 Follicles
Standard Deviation 2.3
|
Adverse Events
AS900672-Enriched 10 Mcg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
AS900672-Enriched 20 Mcg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AS900672-Enriched 30 Mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
AS900672-Enriched 40 Mcg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Follitropin Alfa 75 IU
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AS900672-Enriched 10 Mcg
n=14 participants at risk
Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 20 Mcg
n=14 participants at risk
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 30 Mcg
n=15 participants at risk
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
AS900672-Enriched 40 Mcg
n=13 participants at risk
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
Follitropin Alfa 75 IU
n=15 participants at risk
Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
20.0%
3/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
23.1%
3/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
13.3%
2/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.7%
1/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Migraine
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
6.7%
1/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
6.7%
1/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
6.7%
1/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Reproductive system and breast disorders
Adnexa uteri pain
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
6.7%
1/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
13.3%
2/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.7%
1/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.7%
1/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
13.3%
2/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.7%
1/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.7%
1/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
6.7%
1/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.7%
1/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.7%
1/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.7%
1/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
6.7%
1/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
6.7%
1/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
6.7%
1/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
6.7%
1/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Eye disorders
Eye pain
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.7%
1/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
6.7%
1/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/14 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
6.7%
1/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/13 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/15 • Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER