Trial · NCT01416987
A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
NCT01416987, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2019-07-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa). Trials, record NCT01416987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01416987
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
- NCT number
- NCT01416987
- Status
- Completed
- Enrollment
- 600 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Infertility
- Interventions
- Pergoveris®
- First posted
- 2011-08-15
- Last updated
- 2019-07-19
- Results first posted
- 2019-07-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) | 2463 days | Safety analysis set included all participants who received at least one dose of Pergoveris®. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography | 2463 days | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Pregnancy as Per Safety Analysis Set | 2463 days | Safety analysis set included all participants who received at least one dose of Pergoveris®. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set | 2463 days | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) | Pergoveris® | Adverse event (AE) | 16 | Participants | |
| Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) | Pergoveris® | Adverse drug reaction (ADR) | 13 | Participants | |
| Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography | Pergoveris® | 528 | Participants | ||
| Number of Participants With Clinical Pregnancy as Per Safety Analysis Set | Pergoveris® | 246 | Participants | ||
| Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set | Pergoveris® | 227 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pergoveris® | 600 | |
| Overall Study | COMPLETED | Pergoveris® | 600 | |
| Overall Study | NOT COMPLETED | Pergoveris® | 0 |
Source ClinicalTrials.gov
Adverse events11
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | Pergoveris® | 7 | 600 | |
| other | Abdominal distension | Gastrointestinal disorders | Pergoveris® | 1 | 600 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Pergoveris® | 1 | 600 | |
| other | Nausea | Gastrointestinal disorders | Pergoveris® | 1 | 600 | |
| other | Injection site erythema | General disorders | Pergoveris® | 1 | 600 | |
| other | Injection site pain | General disorders | Pergoveris® | 1 | 600 | |
| other | Injection site pruritus | General disorders | Pergoveris® | 1 | 600 | |
| other | Nasopharyngitis | Infections and infestations | Pergoveris® | 1 | 600 | |
| other | Nasal obstruction | Respiratory, thoracic and mediastinal disorders | Pergoveris® | 1 | 600 | |
| serious | Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | Pergoveris® | 1 | 600 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pergoveris® | 0 | 600 |
| Total, other adverse events | Pergoveris® | 14 | 600 |
| Total, serious adverse events | Pergoveris® | 2 | 600 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01416987
GET https://conductscience.org/api/trials/v1/NCT01416987/registered