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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023534-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck Serono S.A., Geneva | INDUSTRY |
| Merck A/S, Denmark | INDUSTRY |
| Merck OY, Finland | INDUSTRY |
| Merck Serono S.A.S, France |
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:
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 For subjects who have withdrawn from treatment (i.e. after starting Pergoveris® or Gonal-f® but before hCG is given) this visit will take place 20-30 days after their first Pergoveris® or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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gonal-f® Plus Pergoveris® | Active Comparator |
| |
| Pergoveris® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gonal-f® | Drug | Gonal-f® (follitropin alfa) 300 International Unit (IU) will be administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}]) |
| Measure | Description | Time Frame |
|---|---|---|
| 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]) | |
| Total Number of Stimulation Treatment Days | Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore Longobardi, MD | Merck Serono S.P.A., Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Dronninglund | Denmark | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | H Behre, C Howles, S Longobardi. Luteinizing hormone supplementation from Day 1 versus 6 of ovarian stimulation in women aged 36-40 years: results from an open-label, randomized, multicentre, multinational trial. Human Reproduction. 2013;28(suppl 1) | ||
| 26194884 | Result | Behre HM, Howles CM, Longobardi S; PERSIST Study Investigators. Randomized trial comparing luteinizing hormone supplementation timing strategies in older women undergoing ovarian stimulation. Reprod Biomed Online. 2015 Sep;31(3):339-46. doi: 10.1016/j.rbmo.2015.06.002. Epub 2015 Jun 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| INDUSTRY |
| Merck Serono GmbH, Germany | INDUSTRY |
| Merck A.E., Greece | INDUSTRY |
| Merck B.V., Netherlands | INDUSTRY |
| Merck SP. Z.O.O., Poland | INDUSTRY |
| Merck Serono S.P.A., Italy | INDUSTRY |
| Merck Services U.K. Ltd, UK | INDUSTRY |
| LLC Merck, Russia | INDUSTRY |
| Merck spol. s r.o., Slovakia | INDUSTRY |
| Merck Pharma, K.S., Slovakia | INDUSTRY |
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|
| Pergoveris® | Drug | 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. |
|
| Pergoveris® | Drug | Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice. |
|
| Recombinant human chorionic gonadotropin (r-hCG) | Drug | 250 microgram of r-hCG will be administered once subcutaneously on r-hCG day (at least 1 follicles >= 18 mm). |
|
|
| 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. | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
| Number of Fetal Sacs With Activity | Number of fetal sacs with activity was evaluated by ultrasound scan | Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) |
| Number of Fetal Hearts With Activity | Number of fetal hearts with activity was evaluated by ultrasound scan | Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) |
| 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]). | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
| 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. | S1 until Day 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
| 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. | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
| Number of Participants With Multiple Pregnancies | Multiple pregnancy was defined as the existence of more than one fetal sac with fetal heart activity. | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
| 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. | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
| 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. | Day 1 up to days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
| 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]) |
| Fredericia |
| Denmark |
| Research Site | Helsinki | Finland |
| Research Site | Bondy | France |
| Research Site | Bruges | France |
| Research Site | Clamart | France |
| Research Site | Thenon | France |
| Research Site | Villeurbanne | France |
| Research Site | Berlin | Germany |
| Research Site | Halle | Germany |
| Research Site | Heraklion | Crete | Greece |
| Research Site | Pylaia | Thessaloniki | Greece |
| Research Site | Athens | Greece |
| Research Site | Bologna | Italy |
| Research Site | Florence | Italy |
| Research Site | Torino | Italy |
| Research Site | Zwolle | Netherlands |
| Research Site | Warsaw | Poland |
| Research Site | Moscow | Russia |
| Research Site | Samara | Russia |
| Research Site | Bratislava | Slovakia |
| Research Site | London | United Kingdom |
| Research Site | Swansea | United Kingdom |
| FG001 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | centimeter |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilogram |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | oocytes | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}]) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. | Posted | Mean | Standard Deviation | IU | Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Number of Stimulation Treatment Days | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. | Posted | Mean | Standard Deviation | days | Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percent sacs per embryo | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Fetal Sacs With Activity | Number of fetal sacs with activity was evaluated by ultrasound scan | 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. | Posted | Mean | Standard Deviation | fetal sacs | Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Fetal Hearts With Activity | Number of fetal hearts with activity was evaluated by ultrasound scan | 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. | Posted | Mean | Standard Deviation | fetal hearts | Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) |
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| 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]). | 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. | Posted | Number | percentage of participants | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
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| 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. | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. | Posted | Number | participants | S1 until Day 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
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| 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. | 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. | Posted | Number | participants | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
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| Secondary | Number of Participants With Multiple Pregnancies | Multiple pregnancy was defined as the existence of more than one fetal sac with fetal heart activity. | 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. | Posted | Number | participants | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
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| 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. | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. | Posted | Number | participants | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
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| 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. | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. | Posted | Number | participants | Day 1 up to days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
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| Secondary | Systolic and Diastolic Arterial Blood Pressure Assessments | 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. | Posted | Mean | Standard Deviation | millimeter of mercury ( mm Hg) | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
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| Secondary | Heart Rate Assessments | 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. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
|
Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 2 | 99 | 31 | 99 | ||
| EG001 | 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. | 0 | 103 | 32 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Lip pruritus | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Adnexa uteri pain | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Escherichia vaginitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Eye infection viral | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vaginitis bacterial | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Waist circumference increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oestradiol increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Non-systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Myopia | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C571801 | follitropin alfa |
| C551396 | pergoveris |
| D006063 | Chorionic Gonadotropin |
| C412828 | Ovidrel |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Other |
|
| White |
|
| Superiority or Other (legacy) |
|
|
| Units | Counts |
|---|---|
| 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. |
|
|
|
|
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.
|
|
|
|
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.
|
|
|
|
|
|
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|