Assisted Reproductive Techniques, Reproductive Technology, Assisted
Conditions
Keywords
Ovulation Induction, Ovarian Stimulation, Reproductive Technique, Assisted, Assisted Reproductive Technics, Assisted Reproductive Technique, Reproductive Technology, Assisted
Brief summary
This is a multicenter, multi-national, randomized, open-label comparative trial. After screening, the subjects will start down-regulation treatment on Day 21-22 of the cycle. Down-regulation treatment will start within 2 months following the screening visit. The routine long luteal phase protocol for gonadotropin-releasing hormone (GnRH) agonist treatment will be followed. Once down-regulation has been confirmed, a pregnancy test will be performed just before randomization and start of recombinant human follicle-stimulating hormone (r-hFSH) treatment to rule out any pre-existing pregnancy. If the result is negative, the subject will be randomly assigned to one of the two treatment arms of the trial: * GONAL-f®: (Liquid Pen; 300 international unit \[IU\] of per day) stimulation Day 1-5 followed by Pergoveris® (vial/powder, 300 IU per day) from stimulation Day 6 and until required recombinant human chorionic hormone (r-hCG) criterion is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. * Pergoveris®: (vial/powder, 300 IU per day) from stimulation Day 1 and until required r-hCG criterion is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. Randomization across the two treatment arms will be kept balanced in a 1:1 ratio. Follicular development will be monitored according to the center's standard practice by ultrasound (US) and/or estradiol (E2) levels, until the protocol r-hCG requirement is met (i.e., at least one follicle greater than or equal to \[\>=\] 18 millimeter \[mm\] and two follicles \>=16 mm). After this, a single injection of r-hCG will be administered in order to induce final oocyte maturation. At a time of 34-38 hours after r-hCG administration, oocytes will be recovered vaginally under US monitoring. Oocytes will then be fertilized in vitro and embryos replaced 2-5 days after oocyte recovery. Ovum pick up (OPU), in vitro fertilization (IVF), embryo transfer (ET) and luteal support will be performed as per center's standard practice. A post-treatment safety visit will be performed for all subjects who received r-hCG (pregnant and non- pregnant) on Day 15-20 post-hCG. For subjects who have withdrawn from treatment (i.e. after starting Pergoveris® or Gonal-f® but before hCG is given) this visit will take place 20-30 days after their first Pergoveris® or Gonal-f® treatment injection (excluding pregnancy testing).
Interventions
DRUGGonal-f®
Gonal-f® (follitropin alfa) 300 International Unit (IU) will be administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5).
DRUGPergoveris®
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 1 follicles \>= 18 mm). The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
250 microgram of r-hCG will be administered once subcutaneously on r-hCG day (at least 1 follicles \>= 18 mm).
Sponsors
Merck Serono S.A., Geneva
Merck A/S, Denmark
Merck OY, Finland
Merck Serono S.A.S, France
Merck Serono GmbH, Germany
Merck A.E., Greece
Merck B.V., Netherlands
Merck SP. Z.O.O., Poland
Merck Serono S.P.A., Italy
Merck Services U.K. Ltd, UK
LLC Merck, Russia
Merck spol. s r.o., Slovakia
Merck Pharma, K.S., Slovakia
Merck KGaA, Darmstadt, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
36 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Be a female subject justifying an in vitro fertilization and embryo transfer (IVF/ET) treatment * Be between her 36th and 40th birthday (both included) at the time of the randomization visit * Have early follicular phase (Day 2-4) serum level of basal follicle stimulating hormone (FSH less than or equal to (=\<)12 IU/L) measured in the center's local laboratory during the screening period (that is within 2 months prior to down-regulation start) * A body mass index (BMI) less than (\<) 30 kilogram per square meter (kg/m\^2) * Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length * Be willing and able to comply with the protocol for the duration of the trial * Have given written informed consent, prior to any trial-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care * Have a male partner with semen analysis within the past 6 months prior to randomization considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used * Other protocol specified inclusion criteria could also apply.
Exclusion criteria
* Had \>= 2 previous ART cycles with a poor response to gonadotrophin stimulation defined as =\< 6 mature follicles and/or =\<4 oocytes collected in any previous IVF cycle or previous cycles with a hyper response defined as \>= 25 oocytes retrieved * Any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Merck Serono's medical responsible * Had previous severe ovarian Hyperstimulation Syndrome (OHSS) * Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS * Any contraindication to being pregnant and/or carrying a pregnancy to term * History of 3 or more miscarriages (early or late miscarriages) due to any cause * A clinically significant systemic disease * Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner * Known allergy or hypersensitivity to human gonadotrophin preparations * Entered previously into this trial or simultaneous participation in another clinical trial. * Pregnancy and lactation period * Participation in another clinical trial within the past 30 days * Other protocol specified inclusion criteria could also apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Oocytes Retrieved | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}]) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Stimulation Treatment Days | Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) | — |
| Implantation Rate | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Implantation rate per reporting group was measured as the number of fetal sacs observed, divided by the number of embryos transferred multiplied by 100. |
| Number of Fetal Sacs With Activity | Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) | Number of fetal sacs with activity was evaluated by ultrasound scan |
| Number of Fetal Hearts With Activity | Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) | Number of fetal hearts with activity was evaluated by ultrasound scan |
| Clinical Pregnancy Rate | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) | 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 \[ET\]). |
| Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment | S1 until Day 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) | 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. |
| Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) | Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) | — |
| Number of Participants With Multiple Pregnancies | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Multiple pregnancy was defined as the existence of more than one fetal sac with fetal heart activity. |
| Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS) | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) | 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. |
| Number of Participants With Treatment-emergent Adverse Events | Day 1 up to days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 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. |
| Systolic and Diastolic Arterial Blood Pressure Assessments | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) | — |
| Heart Rate Assessments | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) | — |
| Biochemical Pregnancies Rate | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) | 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. |
Countries
Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Poland, Russia, Slovakia, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 99 |
| 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. | 103 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | All Embryos Discarded | 0 | 1 |
| Overall Study | Intention to Freeze all Embryos | 0 | 1 |
| Overall Study | Lack of Ovarian Response | 1 | 1 |
| Overall Study | No Fertilization | 6 | 4 |
| Overall Study | No Oocytes Retrieved | 1 | 1 |
| Overall Study | Ovarian hyperstimulation syndrome risk | 0 | 1 |
| Overall Study | Poor oocyte quality | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Gonal-f® Plus Pergoveris® | Pergoveris® |
|---|---|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 1.15 | 37.6 years STANDARD_DEVIATION 1.16 | 37.4 years STANDARD_DEVIATION 1.14 |
| Height | 166.2 centimeter STANDARD_DEVIATION 6.46 | 166.1 centimeter STANDARD_DEVIATION 6.49 | 166.3 centimeter STANDARD_DEVIATION 6.47 |
| Race Asian | 10 participants | 4 participants | 6 participants |
| Race Black | 7 participants | 4 participants | 3 participants |
| Race Other | 4 participants | 2 participants | 2 participants |
| Race White | 181 participants | 89 participants | 92 participants |
| Sex: Female, Male Female | 202 Participants | 99 Participants | 103 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 65.33 kilogram STANDARD_DEVIATION 9.645 | 64.81 kilogram STANDARD_DEVIATION 10.364 | 65.82 kilogram STANDARD_DEVIATION 8.923 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 31 / 99 | 32 / 103 |
| serious Total, serious adverse events | 2 / 99 | 0 / 103 |
Outcome results
Primary
Total Number of Oocytes Retrieved
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gonal-f® Plus Pergoveris® | Total Number of Oocytes Retrieved | 10.9 oocytes | Standard Deviation 6.5 |
| Pergoveris® | Total Number of Oocytes Retrieved | 9.7 oocytes | Standard Deviation 6.9 |
Comparison: The null hypothesis was that the difference between the mean number of oocytes is less than (-3) or greater than (+3) between the two treatment arm. The alternate hypothesis was that the difference is between (-3) and (+3). The study had 80% power to show that the group randomized to Pergoveris® has an absolute difference of no more than 3 oocytes retrieved in comparison to the group randomized to GONAL-f®/Pergoveris®95% CI: [-3.15, 0.59]ANOVA
Secondary
Biochemical Pregnancies Rate
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gonal-f® Plus Pergoveris® | Biochemical Pregnancies Rate | 23 participants |
| Pergoveris® | Biochemical Pregnancies Rate | 41 participants |
Secondary
Clinical Pregnancy Rate
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 \[ET\]).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gonal-f® Plus Pergoveris® | Clinical Pregnancy Rate | Clinical pregnancy rate per cycle (n=97, 101) | 17.5 percentage of participants |
| Gonal-f® Plus Pergoveris® | Clinical Pregnancy Rate | Total clinical pregnancy rate (n=97, 101) | 17.5 percentage of participants |
| Gonal-f® Plus Pergoveris® | Clinical Pregnancy Rate | Clinical pregnancy rate per ET (n=90, 93) | 18.9 percentage of participants |
| Pergoveris® | Clinical Pregnancy Rate | Total clinical pregnancy rate (n=97, 101) | 31.7 percentage of participants |
| Pergoveris® | Clinical Pregnancy Rate | Clinical pregnancy rate per cycle (n=97, 101) | 31.7 percentage of participants |
| Pergoveris® | Clinical Pregnancy Rate | Clinical pregnancy rate per ET (n=90, 93) | 34.4 percentage of participants |
Secondary
Heart Rate Assessments
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gonal-f® Plus Pergoveris® | Heart Rate Assessments | 75.7 beats per minute (bpm) | Standard Deviation 10.5 |
| Pergoveris® | Heart Rate Assessments | 76.5 beats per minute (bpm) | Standard Deviation 10 |
Secondary
Implantation Rate
Implantation rate per reporting group was measured as the number of fetal sacs observed, divided by the number of embryos transferred multiplied by 100.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gonal-f® Plus Pergoveris® | Implantation Rate | 13.3 percent sacs per embryo | Standard Deviation 29.1 |
| Pergoveris® | Implantation Rate | 24.7 percent sacs per embryo | Standard Deviation 36.1 |
Secondary
Number of Fetal Hearts With Activity
Number of fetal hearts with activity was evaluated by ultrasound scan
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gonal-f® Plus Pergoveris® | Number of Fetal Hearts With Activity | 1.4 fetal hearts | Standard Deviation 0.5 |
| Pergoveris® | Number of Fetal Hearts With Activity | 1.3 fetal hearts | Standard Deviation 0.5 |
Secondary
Number of Fetal Sacs With Activity
Number of fetal sacs with activity was evaluated by ultrasound scan
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gonal-f® Plus Pergoveris® | Number of Fetal Sacs With Activity | 1.4 fetal sacs | Standard Deviation 0.5 |
| Pergoveris® | Number of Fetal Sacs With Activity | 1.2 fetal sacs | Standard Deviation 0.4 |
Secondary
Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment
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.
Time frame: 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®.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gonal-f® Plus Pergoveris® | Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment | Insufficient ovarian response | 1 participants |
| Gonal-f® Plus Pergoveris® | Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment | Excessive ovarian response | 0 participants |
| Pergoveris® | Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment | Insufficient ovarian response | 1 participants |
| Pergoveris® | Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment | Excessive ovarian response | 1 participants |
Secondary
Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS)
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.
Time frame: 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®.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gonal-f® Plus Pergoveris® | Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS) | Early Ovarian hyperstimulation syndrome | 4 participants |
| Gonal-f® Plus Pergoveris® | Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS) | Late Ovarian hyperstimulation syndrome | 0 participants |
| Pergoveris® | Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS) | Early Ovarian hyperstimulation syndrome | 1 participants |
| Pergoveris® | Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS) | Late Ovarian hyperstimulation syndrome | 1 participants |
Secondary
Number of Participants With Multiple Pregnancies
Multiple pregnancy was defined as the existence of more than one fetal sac with fetal heart activity.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gonal-f® Plus Pergoveris® | Number of Participants With Multiple Pregnancies | 6 participants |
| Pergoveris® | Number of Participants With Multiple Pregnancies | 8 participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events
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.
Time frame: 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®.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gonal-f® Plus Pergoveris® | Number of Participants With Treatment-emergent Adverse Events | 26 participants |
| Pergoveris® | Number of Participants With Treatment-emergent Adverse Events | 23 participants |
Secondary
Systolic and Diastolic Arterial Blood Pressure Assessments
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gonal-f® Plus Pergoveris® | Systolic and Diastolic Arterial Blood Pressure Assessments | Systolic Blood Pressure | 118.9 millimeter of mercury ( mm Hg) | Standard Deviation 12.8 |
| Gonal-f® Plus Pergoveris® | Systolic and Diastolic Arterial Blood Pressure Assessments | Diastolic Blood Pressure | 74.8 millimeter of mercury ( mm Hg) | Standard Deviation 9.8 |
| Pergoveris® | Systolic and Diastolic Arterial Blood Pressure Assessments | Systolic Blood Pressure | 121.2 millimeter of mercury ( mm Hg) | Standard Deviation 14.8 |
| Pergoveris® | Systolic and Diastolic Arterial Blood Pressure Assessments | Diastolic Blood Pressure | 76.8 millimeter of mercury ( mm Hg) | Standard Deviation 9.5 |
Secondary
Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)
Time frame: 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®.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gonal-f® Plus Pergoveris® | Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) | Total Dose | 3292 IU | Standard Deviation 851 |
| Gonal-f® Plus Pergoveris® | Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) | Mean Daily Dose | 307 IU | Standard Deviation 43 |
| Pergoveris® | Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) | Total Dose | 3321 IU | Standard Deviation 850 |
| Pergoveris® | Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) | Mean Daily Dose | 311 IU | Standard Deviation 41 |
Secondary
Total Number of Stimulation Treatment Days
Time frame: 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®.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gonal-f® Plus Pergoveris® | Total Number of Stimulation Treatment Days | 10.6 days | Standard Deviation 1.6 |
| Pergoveris® | Total Number of Stimulation Treatment Days | 10.6 days | Standard Deviation 1.7 |