Infertility
Conditions
Brief summary
This prospective study collected safety information from more than 600 participants treated with Pergoveris®. During the Post-Marketing Surveillance (PMS) period, data about the participant's background, participant's medical history, Pergoveris® indication, prior infertility medication, Pergoveris® treatment status, concomitant drugs, all adverse events (regardless of the causal relationship to Pergoveris®) and efficacy (follicular growth and clinical pregnancy) were collected for study purposes.The post marketing surveillance was based on all cases treated with Pergoveris®.
Interventions
DRUGPergoveris®
Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
Sponsors
Merck Ltd.
Merck KGaA, Darmstadt, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Participants, who were eligible for Pergoveris® treatment according to the indication in the national label of Pergoveris®. The national label approved by Korea Food & Drug Administration is Pergoveris® in association with a follicle stimulating hormone(FSH) preparation was recommended for the stimulation of follicular development in women with severe Luteinizing Hormone (LH) and FSH deficiency. In clinical trials these participants were defined by an endogenous serum LH level less than (\<)1.2 International units per liter IU/L
Exclusion criteria
* According to national label
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) | 2463 days | Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse events included both Serious AEs and non-serious AEs. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse Drug Reactions (ADR) was defined as an adverse event for which a causal relationship between the product and the occurrence was suspected, that was judged possible or probable by the reporting physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography | 2463 days | Number of participants with one follicle of more than 17mm of mean diameter on ultrasonography were reported. |
| Number of Participants With Clinical Pregnancy as Per Safety Analysis Set | 2463 days | The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation. |
| Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set | 2463 days | The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pergoveris® Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days. | 600 |
| Total | 600 |
Baseline characteristics
| Characteristic | Pergoveris® | — |
|---|---|---|
| Age, Continuous | 34.58 Years STANDARD_DEVIATION 3.83 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 600 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 600 |
| other Total, other adverse events | 14 / 600 |
| serious Total, serious adverse events | 2 / 600 |
Outcome results
Primary
Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR)
Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse events included both Serious AEs and non-serious AEs. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse Drug Reactions (ADR) was defined as an adverse event for which a causal relationship between the product and the occurrence was suspected, that was judged possible or probable by the reporting physician.
Time frame: 2463 days
Population: Safety analysis set included all participants who received at least one dose of Pergoveris®.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pergoveris® | Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) | Adverse event (AE) | 16 Participants |
| Pergoveris® | Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) | Adverse drug reaction (ADR) | 13 Participants |
Secondary
Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography
Number of participants with one follicle of more than 17mm of mean diameter on ultrasonography were reported.
Time frame: 2463 days
Population: Effectiveness analysis set included participants who were evaluated for follicular growth (FG) after treatment with Pergoveris®, except those; who were not assessed for FG; whose assessments of FG were considered 'undecidable' based on Human Chorionic Gonadotropin (HCG) not administered, ultrasonography not done on the day of HCG administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pergoveris® | Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography | 528 Participants |
Secondary
Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set
The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation.
Time frame: 2463 days
Population: Effectiveness analysis set included participants who were evaluated for follicular growth (FG) after treatment with Pergoveris ®, except those; who were not assessed for FG; whose assessments of FG were considered 'undecidable' based on Human Chorionic Gonadotropin (HCG) not administered, ultrasonography not done on the day of HCG administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pergoveris® | Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set | 227 Participants |
Secondary
Number of Participants With Clinical Pregnancy as Per Safety Analysis Set
The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation.
Time frame: 2463 days
Population: Safety analysis set included all participants who received at least one dose of Pergoveris®.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pergoveris® | Number of Participants With Clinical Pregnancy as Per Safety Analysis Set | 246 Participants |