Trial · NCT01497197
A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique
NCT01497197, Phase 3, Terminated, Merck KGaA, Darmstadt, Germany; results first posted 2015-11-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique. Trials, record NCT01497197. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01497197
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique
- NCT number
- NCT01497197
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 174 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Infertility, Fertility, Follicle Stimulating Hormone Deficiency
- Interventions
- GONAL-f®, Luveris®, Recombinant human chorionic gonadotropin (r-hCG)
- First posted
- 2011-12-22
- Last updated
- 2015-11-09
- Results first posted
- 2015-11-09
- Limitations and caveats
- Study was terminated as per sponsor's decision.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation | 34-38 hours post r-hCG administration | Ovarian stimulation was performed using in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The total number of oocytes collected per subject following stimulation was reported. |
| Secondary | Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) | Screening | Mean daily dose of FSH was to be determined by dividing the total daily dose by the number of stimulation days. |
| Secondary | Total Number of Stimulation Treatment Days | 6 days post stimulation (Number of stimulation days+6 days) | The total number of stimulation treatment days for each subject was determined based on the treatment administration information collected in the case report form. |
| Secondary | Implantation Rate | 35-42 days post r-hCG administration | The implantation rate was determined as number of fetal sacs divided by the number of embryos transferred post r-hCG administration. |
| Secondary | Number of Fetal Sacs With Activity | 35-42 days post r-hCG administration | Number of fetal sacs with activity was evaluated by ultrasound scan (US) on Days 35-42 post r-hCG to confirm clinical pregnancy. |
| Secondary | Number of Fetal Sacs With Detectable Heart Beats | 35-42 days post r-hCG administration | Number of fetal sacs with detectable heart beats was evaluated by US on Days 35-42 post r-hCG to confirm clinical pregnancy |
| Secondary | Total Pregnancy Rate and Clinical Pregnancy Rate | 35-42 days post r-hCG administration | The subject was considered to have a positive pregnancy result if beta-hCG \>10 international units per liter (IU/L) and the subject had not menstruated between post-r-hCG Days 15-20. Clinical pregnancy was defined as the existence of at least an US confirmed gestational sac in the uterus with fetal heart activity post-r-hCG Days 35-42. |
| Secondary | Cycle Cancellation Rate Prior to r-hCG | Up to 85 days | If the subject was not administered with r-hCG and withdrew prematurely from the trial, it was considered as cycle cancellation. |
| Secondary | Number of Subjects With Biochemical Pregnancies | 35 to 42 days post r-hCG administration | Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Subjects with beta-hCG concentration greater than 10 IU/L were considered as biochemical pregnant. |
| Secondary | Number of Subjects With Multiple Pregnancies | 35 to 42 days post r-hCG administration | Multiple pregnancy was defined as the existence of more than one ultrasound confirmed gestational sac in the uterus with fetal heart activity at post-r-hCG Days 35-42. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 Per Subject Following Ovarian Stimulation | 34-38 hours post r-hCG administration | Modified intention-to-treat (MITT) included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following recombinant human follicle stimulating hormone (r-hFSH) stimulation and r-hCG injection). | oocytes | MEAN |
| SECONDARY | Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) | Screening | Data was not analysed as per planned analysis due to frequent protocol violations/deviations, there was no subject eligible to be analyzed per protocol. | ||
| SECONDARY | Total Number of Stimulation Treatment Days | 6 days post stimulation (Number of stimulation days+6 days) | MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection). | days | MEAN |
| SECONDARY | Implantation Rate | 35-42 days post r-hCG administration | MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all subjects who showed positive pregnancy test and evaluable for this outcome measure. | fetal sacs/embryo transferred | MEAN |
| SECONDARY | Number of Fetal Sacs With Activity | 35-42 days post r-hCG administration | MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all participants who showed positive pregnancy test and evaluable for this outcome measure. | Fetal sacs | MEAN |
| SECONDARY | Number of Fetal Sacs With Detectable Heart Beats | 35-42 days post r-hCG administration | MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all participants who showed positive pregnancy test and evaluable for this outcome measure. | Fetal sacs | MEAN |
| SECONDARY | Total Pregnancy Rate and Clinical Pregnancy Rate | 35-42 days post r-hCG administration | MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection). | percentage of subjects | NUMBER |
| SECONDARY | Cycle Cancellation Rate Prior to r-hCG | Up to 85 days | MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection). | percentage of subjects | NUMBER |
| SECONDARY | Number of Subjects With Biochemical Pregnancies | 35 to 42 days post r-hCG administration | MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection). | subjects | NUMBER |
| SECONDARY | Number of Subjects With Multiple Pregnancies | 35 to 42 days post r-hCG administration | MITT included all subjects randomized into trial who received at least 1 dose of Gonal-f® or Luveris®, and completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection). 'N'=signifies all subjects who showed positive pregnancy test and evaluable for this outcome measure. | subjects | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group28
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 Per Subject Following Ovarian Stimulation | Gonal-f®+Luveris | 8.6 | Standard Deviation 6.54 | oocytes | |
| Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation | Gonal-f® Followed by Luveris | 8.7 | Standard Deviation 5.77 | oocytes | |
| Total Number of Stimulation Treatment Days | Gonal-f®+Luveris | 11.1 | Standard Deviation 2.42 | days | |
| Total Number of Stimulation Treatment Days | Gonal-f® Followed by Luveris | 11.3 | Standard Deviation 2.24 | days | |
| Implantation Rate | Gonal-f®+Luveris | 0.5 | Standard Deviation 0.51 | fetal sacs/embryo transferred | |
| Implantation Rate | Gonal-f® Followed by Luveris | 0.4 | Standard Deviation 0.51 | fetal sacs/embryo transferred | |
| Number of Fetal Sacs With Activity | Gonal-f®+Luveris | 0.8 | Standard Deviation 0.42 | Fetal sacs | |
| Number of Fetal Sacs With Activity | Gonal-f® Followed by Luveris | 1.1 | Standard Deviation 0.54 | Fetal sacs | |
| Number of Fetal Sacs With Detectable Heart Beats | Gonal-f®+Luveris | 0.6 | Standard Deviation 0.50 | Fetal sacs | |
| Number of Fetal Sacs With Detectable Heart Beats | Gonal-f® Followed by Luveris | 1.0 | Standard Deviation 0.45 | Fetal sacs |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 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®+Luveris | 89 | |
| Overall Study | STARTED | Gonal-f® Followed by Luveris | 85 | |
| Overall Study | COMPLETED | Gonal-f®+Luveris | 72 | |
| Overall Study | COMPLETED | Gonal-f® Followed by Luveris | 70 | |
| Overall Study | NOT COMPLETED | Gonal-f®+Luveris | 17 | |
| Overall Study | NOT COMPLETED | Gonal-f® Followed by Luveris | 15 |
Source ClinicalTrials.gov
Adverse events16
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 | Overdose | Injury, poisoning and procedural complications | Gonal-f®+Luveris | 13 | 89 | |
| other | Overdose | Injury, poisoning and procedural complications | Gonal-f® Followed by Luveris | 14 | 85 | |
| other | Oestradiol increased | Investigations | Gonal-f®+Luveris | 8 | 89 | |
| other | Oestradiol increased | Investigations | Gonal-f® Followed by Luveris | 8 | 85 | |
| other | Progesterone increased | Investigations | Gonal-f®+Luveris | 0 | 89 | |
| other | Progesterone increased | Investigations | Gonal-f® Followed by Luveris | 1 | 85 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Gonal-f®+Luveris | 0 | 89 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Gonal-f® Followed by Luveris | 1 | 85 | |
| other | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Gonal-f®+Luveris | 2 | 89 | |
| other | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Gonal-f® Followed by Luveris | 5 | 85 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gonal-f®+Luveris | ||
| Total, all-cause mortality | Gonal-f® Followed by Luveris | ||
| Total, other adverse events | Gonal-f®+Luveris | 24 | 89 |
| Total, other adverse events | Gonal-f® Followed by Luveris | 27 | 85 |
| Total, serious adverse events | Gonal-f®+Luveris | 4 | 89 |
| Total, serious adverse events | Gonal-f® Followed by Luveris | 5 | 85 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Gonal-f®+Luveris vs Gonal-f® Followed by Luveris: serious adverse events |
Source 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/NCT01497197
GET https://conductscience.org/api/trials/v1/NCT01497197/results?page=2