Trial Outcomes & Findings for PERgoveriS In Stratified Treatment for Assisted Reproductive Technique (NCT NCT01297465)
NCT ID: NCT01297465
Last Updated: 2021-05-28
Results Overview
The total number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
202 participants
Primary outcome timeframe
OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}])
Results posted on
2021-05-28
Participant Flow
Participant milestones
| Measure |
Gonal-f® Plus Pergoveris®
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
103
|
|
Overall Study
COMPLETED
|
91
|
93
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
Gonal-f® Plus Pergoveris®
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Overall Study
Lack of Ovarian Response
|
1
|
1
|
|
Overall Study
Ovarian hyperstimulation syndrome risk
|
0
|
1
|
|
Overall Study
No Oocytes Retrieved
|
1
|
1
|
|
Overall Study
Poor oocyte quality
|
0
|
1
|
|
Overall Study
No Fertilization
|
6
|
4
|
|
Overall Study
All Embryos Discarded
|
0
|
1
|
|
Overall Study
Intention to Freeze all Embryos
|
0
|
1
|
Baseline Characteristics
PERgoveriS In Stratified Treatment for Assisted Reproductive Technique
Baseline characteristics by cohort
| Measure |
Gonal-f® Plus Pergoveris®
n=99 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=103 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 1.16 • n=5 Participants
|
37.4 years
STANDARD_DEVIATION 1.14 • n=7 Participants
|
37.5 years
STANDARD_DEVIATION 1.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race
Black
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race
Asian
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race
Other
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race
White
|
89 participants
n=5 Participants
|
92 participants
n=7 Participants
|
181 participants
n=5 Participants
|
|
Height
|
166.1 centimeter
STANDARD_DEVIATION 6.49 • n=5 Participants
|
166.3 centimeter
STANDARD_DEVIATION 6.47 • n=7 Participants
|
166.2 centimeter
STANDARD_DEVIATION 6.46 • n=5 Participants
|
|
Weight
|
64.81 kilogram
STANDARD_DEVIATION 10.364 • n=5 Participants
|
65.82 kilogram
STANDARD_DEVIATION 8.923 • n=7 Participants
|
65.33 kilogram
STANDARD_DEVIATION 9.645 • n=5 Participants
|
PRIMARY outcome
Timeframe: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}])Population: Modified intention-to-treat (Mod-ITT) population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.
The total number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.
Outcome measures
| Measure |
Gonal-f® Plus Pergoveris®
n=98 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=101 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Total Number of Oocytes Retrieved
|
10.9 oocytes
Standard Deviation 6.5
|
9.7 oocytes
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days])Population: Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.
Outcome measures
| Measure |
Gonal-f® Plus Pergoveris®
n=99 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=103 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)
Total Dose
|
3292 IU
Standard Deviation 851
|
3321 IU
Standard Deviation 850
|
|
Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)
Mean Daily Dose
|
307 IU
Standard Deviation 43
|
311 IU
Standard Deviation 41
|
SECONDARY outcome
Timeframe: Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days])Population: Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.
Outcome measures
| Measure |
Gonal-f® Plus Pergoveris®
n=99 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=103 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Total Number of Stimulation Treatment Days
|
10.6 days
Standard Deviation 1.6
|
10.6 days
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])Population: Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.
Implantation rate per reporting group was measured as the number of fetal sacs observed, divided by the number of embryos transferred multiplied by 100.
Outcome measures
| Measure |
Gonal-f® Plus Pergoveris®
n=90 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=93 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Implantation Rate
|
13.3 percent sacs per embryo
Standard Deviation 29.1
|
24.7 percent sacs per embryo
Standard Deviation 36.1
|
SECONDARY outcome
Timeframe: Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}])Population: Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment."N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Number of fetal sacs with activity was evaluated by ultrasound scan
Outcome measures
| Measure |
Gonal-f® Plus Pergoveris®
n=18 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=35 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Number of Fetal Sacs With Activity
|
1.4 fetal sacs
Standard Deviation 0.5
|
1.2 fetal sacs
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}])Population: Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment."N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Number of fetal hearts with activity was evaluated by ultrasound scan
Outcome measures
| Measure |
Gonal-f® Plus Pergoveris®
n=17 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=32 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Number of Fetal Hearts With Activity
|
1.4 fetal hearts
Standard Deviation 0.5
|
1.3 fetal hearts
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])Population: Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and had completed the primary efficacy assessment. "N" signifies those participants who had their ET in study treatment cycle. "n" signifies those participants who were evaluated for this measure in specified categories.
Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Clinical pregnancy rate was reported as total clinical pregnancy rate, clinical pregnancy rate per cycle started and per embryo transfer \[ET\]).
Outcome measures
| Measure |
Gonal-f® Plus Pergoveris®
n=97 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=101 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Clinical Pregnancy Rate
Total clinical pregnancy rate (n=97, 101)
|
17.5 percentage of participants
|
31.7 percentage of participants
|
|
Clinical Pregnancy Rate
Clinical pregnancy rate per cycle (n=97, 101)
|
17.5 percentage of participants
|
31.7 percentage of participants
|
|
Clinical Pregnancy Rate
Clinical pregnancy rate per ET (n=90, 93)
|
18.9 percentage of participants
|
34.4 percentage of participants
|
SECONDARY outcome
Timeframe: S1 until Day 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])Population: Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.
An excessive ovarian response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An insufficient ovarian response: defined as 3 or less follicles of greater than or equal to 12 millimeter developing following at least 7 days of treatment.
Outcome measures
| Measure |
Gonal-f® Plus Pergoveris®
n=99 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=103 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment
Excessive ovarian response
|
0 participants
|
1 participants
|
|
Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment
Insufficient ovarian response
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])Population: Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment. . "N" (number of participants analyzed) signifies those participants who had their embryo transfer in study treatment cycle.
Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of human chorionic gonadotropin (hCG) in serum or urine and that does not develop into a clinical pregnancy. Participants with beta- hCG concentration greater than 10 international units per liter (IU/L) were considered as biochemical pregnant.
Outcome measures
| Measure |
Gonal-f® Plus Pergoveris®
n=97 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=101 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Biochemical Pregnancies Rate
|
23 participants
|
41 participants
|
SECONDARY outcome
Timeframe: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])Population: Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment. "N" (number of participants analyzed) signifies those participants who had their embryo transfer in study treatment cycle.
Multiple pregnancy was defined as the existence of more than one fetal sac with fetal heart activity.
Outcome measures
| Measure |
Gonal-f® Plus Pergoveris®
n=97 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=101 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Number of Participants With Multiple Pregnancies
|
6 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])Population: Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.
Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. Early OHSS was defined as the onset of OHSS occurring within 9 days after oocyte retrieval and late OHSS was defined as the onset of OHSS occurring on or after day 10 from oocyte retrieval.
Outcome measures
| Measure |
Gonal-f® Plus Pergoveris®
n=99 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=103 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS)
Early Ovarian hyperstimulation syndrome
|
4 participants
|
1 participants
|
|
Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS)
Late Ovarian hyperstimulation syndrome
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1 up to days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])Population: Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.
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.
Outcome measures
| Measure |
Gonal-f® Plus Pergoveris®
n=99 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=103 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events
|
26 participants
|
23 participants
|
SECONDARY outcome
Timeframe: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])Population: Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. ."N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Gonal-f® Plus Pergoveris®
n=93 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=99 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Systolic and Diastolic Arterial Blood Pressure Assessments
Systolic Blood Pressure
|
118.9 millimeter of mercury ( mm Hg)
Standard Deviation 12.8
|
121.2 millimeter of mercury ( mm Hg)
Standard Deviation 14.8
|
|
Systolic and Diastolic Arterial Blood Pressure Assessments
Diastolic Blood Pressure
|
74.8 millimeter of mercury ( mm Hg)
Standard Deviation 9.8
|
76.8 millimeter of mercury ( mm Hg)
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])Population: Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. ."N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Gonal-f® Plus Pergoveris®
n=93 Participants
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=99 Participants
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Heart Rate Assessments
|
75.7 beats per minute (bpm)
Standard Deviation 10.5
|
76.5 beats per minute (bpm)
Standard Deviation 10
|
Adverse Events
Gonal-f® Plus Pergoveris®
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Pergoveris®
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gonal-f® Plus Pergoveris®
n=99 participants at risk
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=103 participants at risk
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
2.0%
2/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
Other adverse events
| Measure |
Gonal-f® Plus Pergoveris®
n=99 participants at risk
Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
|
Pergoveris®
n=103 participants at risk
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
|
|---|---|---|
|
Nervous system disorders
Headache
|
14.1%
14/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
12.6%
13/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Nervous system disorders
Somnolence
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
1.9%
2/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Nervous system disorders
Migraine
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Nervous system disorders
Syncope
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
6/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
3.9%
4/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
2/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
1.9%
2/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.0%
2/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
1.9%
2/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
2.9%
3/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Gastrointestinal disorders
Flatulence
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
1.9%
2/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Gastrointestinal disorders
Dental caries
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Gastrointestinal disorders
Lip pruritus
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
3.0%
3/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
3.9%
4/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
3.0%
3/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
2.9%
3/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.0%
3/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
1.9%
2/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Reproductive system and breast disorders
Adnexa uteri pain
|
2.0%
2/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
1.9%
2/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Reproductive system and breast disorders
Breast pain
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
2.0%
2/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
2.0%
2/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Reproductive system and breast disorders
Breast tenderness
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
2/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
5.8%
6/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Infections and infestations
Oral herpes
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Infections and infestations
Escherichia vaginitis
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Infections and infestations
Eye infection viral
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Infections and infestations
Vaginitis bacterial
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
General disorders
Fatigue
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
1.9%
2/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
General disorders
Injection site induration
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Investigations
Waist circumference increased
|
2.0%
2/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Investigations
Oestradiol increased
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Investigations
Weight increased
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Vascular disorders
Hypertension
|
3.0%
3/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Vascular disorders
Hot flush
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
2/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Cardiac disorders
Extrasystoles
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Eye disorders
Myopia
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.97%
1/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
|
Renal and urinary disorders
Renal colic
|
1.0%
1/99 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
0.00%
0/103 • Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
|
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: LTE60