Trial · NCT01297465
PERgoveriS In Stratified Treatment for Assisted Reproductive Technique
NCT01297465, Phase 3, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2014-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PERgoveriS In Stratified Treatment for Assisted Reproductive Technique. Trials, record NCT01297465. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01297465
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PERgoveriS In Stratified Treatment for Assisted Reproductive Technique
- NCT number
- NCT01297465
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 202 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Assisted Reproductive Techniques, Reproductive Technology, Assisted
- Interventions
- Gonal-f®, Pergoveris®, Pergoveris®, Recombinant human chorionic gonadotropin (r-hCG)
- First posted
- 2011-02-16
- Last updated
- 2021-05-28
- Other registries' IDs
- eudract:2010-023534-23
- Results first posted
- 2014-02-24
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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]) | |
| Secondary | Total Number of Stimulation Treatment Days | Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) | |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 \[ET\]). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Number of Oocytes Retrieved | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}]) | 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. | oocytes | MEAN |
| SECONDARY | 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]) | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. | IU | MEAN |
| SECONDARY | Total Number of Stimulation Treatment Days | Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. | days | MEAN |
| SECONDARY | Implantation Rate | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) | 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. | percent sacs per embryo | MEAN |
| SECONDARY | Number of Fetal Sacs With Activity | Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) | 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. | fetal sacs | MEAN |
| SECONDARY | Number of Fetal Hearts With Activity | Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) | 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. | fetal hearts | MEAN |
| SECONDARY | Clinical Pregnancy Rate | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) | 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. | percentage of participants | NUMBER |
| SECONDARY | 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]) | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. | participants | NUMBER |
| SECONDARY | Biochemical Pregnancies Rate | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) | 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. | participants | NUMBER |
| SECONDARY | Number of Participants With Multiple Pregnancies | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) | 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. | participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Number of Oocytes Retrieved | Gonal-f® Plus Pergoveris® | 10.9 | Standard Deviation 6.5 | oocytes | |
| Total Number of Oocytes Retrieved | Pergoveris® | 9.7 | Standard Deviation 6.9 | oocytes | |
| Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) | Gonal-f® Plus Pergoveris® | Total Dose | 3292 | Standard Deviation 851 | IU |
| Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) | Pergoveris® | Total Dose | 3321 | Standard Deviation 850 | IU |
| Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) | Gonal-f® Plus Pergoveris® | Mean Daily Dose | 307 | Standard Deviation 43 | IU |
| Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) | Pergoveris® | Mean Daily Dose | 311 | Standard Deviation 41 | IU |
| Total Number of Stimulation Treatment Days | Gonal-f® Plus Pergoveris® | 10.6 | Standard Deviation 1.6 | days | |
| Total Number of Stimulation Treatment Days | Pergoveris® | 10.6 | Standard Deviation 1.7 | days | |
| Implantation Rate | Gonal-f® Plus Pergoveris® | 13.3 | Standard Deviation 29.1 | percent sacs per embryo | |
| Implantation Rate | Pergoveris® | 24.7 | Standard Deviation 36.1 | percent sacs per embryo |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gonal-f® Plus Pergoveris® | 99 | |
| Overall Study | STARTED | Pergoveris® | 103 | |
| Overall Study | COMPLETED | Gonal-f® Plus Pergoveris® | 91 | |
| Overall Study | COMPLETED | Pergoveris® | 93 | |
| Overall Study | NOT COMPLETED | Gonal-f® Plus Pergoveris® | 8 | |
| Overall Study | NOT COMPLETED | Pergoveris® | 10 |
Source ClinicalTrials.gov
Adverse events116
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 | Headache | Nervous system disorders | Gonal-f® Plus Pergoveris® | 14 | 99 | |
| other | Headache | Nervous system disorders | Pergoveris® | 13 | 103 | |
| other | Somnolence | Nervous system disorders | Gonal-f® Plus Pergoveris® | 1 | 99 | |
| other | Somnolence | Nervous system disorders | Pergoveris® | 2 | 103 | |
| other | Migraine | Nervous system disorders | Gonal-f® Plus Pergoveris® | 1 | 99 | |
| other | Migraine | Nervous system disorders | Pergoveris® | 0 | 103 | |
| other | Syncope | Nervous system disorders | Gonal-f® Plus Pergoveris® | 0 | 99 | |
| other | Syncope | Nervous system disorders | Pergoveris® | 1 | 103 | |
| other | Abdominal pain | Gastrointestinal disorders | Gonal-f® Plus Pergoveris® | 6 | 99 | |
| other | Abdominal pain | Gastrointestinal disorders | Pergoveris® | 4 | 103 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gonal-f® Plus Pergoveris® | ||
| Total, all-cause mortality | Pergoveris® | ||
| Total, other adverse events | Gonal-f® Plus Pergoveris® | 31 | 99 |
| Total, other adverse events | Pergoveris® | 32 | 103 |
| Total, serious adverse events | Gonal-f® Plus Pergoveris® | 2 | 99 |
| Total, serious adverse events | Pergoveris® | 0 | 103 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26194884 | RESULT |
Source PubMed
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gonal-f® Plus Pergoveris® vs Pergoveris®: Number of Participants With Multiple Pregnancies | Trial comparisons |
| Gonal-f® Plus Pergoveris® vs Pergoveris®: Biochemical Pregnancies Rate | Trial comparisons |
| Gonal-f® Plus Pergoveris® vs Pergoveris®: Number of Participants With Treatment-emergent Adverse Events | Trial comparisons |
| Gonal-f® Plus Pergoveris® vs Pergoveris®: serious adverse events | Trial comparisons |
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/NCT01297465
GET https://conductscience.org/api/trials/v1/NCT01297465/results?page=2