Trial · NCT01956110
Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1
NCT01956110, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2018-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1. Trials, record NCT01956110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01956110
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1
- NCT number
- NCT01956110
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,329 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Infertility
- Interventions
- Follitropin Delta (FE 999049), Follitropin Alfa (GONAL-F)
- First posted
- 2013-10-08
- Last updated
- 2022-01-13
- Other registries' IDs
- eudract:2013-001669-17
- Results first posted
- 2018-09-25
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ongoing Pregnancy Rate | 10-11 weeks after blastocyst transfer | Ongoing pregnancy was defined as at least one intrauterine viable fetus 10-11 weeks after blastocyst transfer. |
| Primary | Ongoing Implantation Rate | 10-11 weeks after blastocyst transfer | Ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred. |
| Secondary | Vital Pregnancy Rate | 5-6 weeks after blastocyst transfer | Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after blastocyst transfer. |
| Secondary | Implantation Rate | 5-6 weeks after blastocyst transfer | Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred. |
| Secondary | Proportion of Subjects With Extreme Ovarian Responses, Defined as <4, ≥15 or ≥20 Oocytes Retrieved | Day of oocyte retrieval | |
| Secondary | Proportion of Subjects With Early OHSS (Ovarian Hyperstimulation Syndrome) and/or Preventive Interventions for Early OHSS | ≤9 days after triggering of final follicular maturation | The proportion of subjects with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented. |
| Secondary | Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response | End-of-stimulation (up to 20 stimulation days) | Proportion of subjects with cycle cancellation due to poor ovarian response, excessive ovarian response, and triggering with gonadotropin-releasing hormone (GnRH) agonist are presented. |
| Secondary | Number of Oocytes Retrieved | Day of oocyte retrieval | |
| Secondary | Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved | Day of oocyte retrieval | |
| Secondary | Percentage of Metaphase II Oocytes (Oocytes Inseminated Using ICSI [Intracytoplasmic Sperm Injection]) | Prior to insemination | Number of oocytes in metaphase II prior to ICSI insemination is presented. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ongoing Pregnancy Rate | 10-11 weeks after blastocyst transfer | Modified intention-to-treat (mITT) analysis set (all randomised and exposed subjects). This is equivalent to full analysis set (FAS). | Percentage of subjects | NUMBER |
| PRIMARY | Ongoing Implantation Rate | 10-11 weeks after blastocyst transfer | Subjects with blastocyst transfer (a total of 585 and 584 blastocysts were transferred in the FE999049 and GONAL-F groups, respectively). | Percentage | NUMBER |
| SECONDARY | Vital Pregnancy Rate | 5-6 weeks after blastocyst transfer | mITT analysis set (all randomised and exposed subjects). This is equivalent to the FAS. | Percentage of subjects | NUMBER |
| SECONDARY | Implantation Rate | 5-6 weeks after blastocyst transfer | Subjects with blastocyst transfer (a total of 585 and 584 blastocysts were transferred in the FE999049 and GONAL-F groups, respectively). | Percentage | NUMBER |
| SECONDARY | Proportion of Subjects With Extreme Ovarian Responses, Defined as <4, ≥15 or ≥20 Oocytes Retrieved | Day of oocyte retrieval | Subjects who underwent triggering of final follicular maturation. | Percentage of subjects | NUMBER |
| SECONDARY | Proportion of Subjects With Early OHSS (Ovarian Hyperstimulation Syndrome) and/or Preventive Interventions for Early OHSS | ≤9 days after triggering of final follicular maturation | mITT analysis set (all randomised and exposed subjects). This is equivalent to the FAS. | Percentage of subjects | NUMBER |
| SECONDARY | Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response | End-of-stimulation (up to 20 stimulation days) | mITT analysis set (all randomised and exposed subjects). This is equivalent to the FAS. | Percentage of subjects | NUMBER |
| SECONDARY | Number of Oocytes Retrieved | Day of oocyte retrieval | Subjects who underwent triggering of final follicular maturation. | Oocytes retrieved | MEAN |
| SECONDARY | Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved | Day of oocyte retrieval | Subjects who underwent triggering of final follicular maturation. | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Metaphase II Oocytes (Oocytes Inseminated Using ICSI [Intracytoplasmic Sperm Injection]) | Prior to insemination | Subjects with all oocytes inseminated using ICSI. | Number of oocytes | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ongoing Pregnancy Rate | FE 999049 | 30.7 | Percentage of subjects | ||
| Ongoing Pregnancy Rate | GONAL-F | 31.6 | Percentage of subjects | ||
| Ongoing Implantation Rate | FE 999049 | 35.2 | Percentage | ||
| Ongoing Implantation Rate | GONAL-F | 35.8 | Percentage | ||
| Vital Pregnancy Rate | FE 999049 | 31.7 | Percentage of subjects | ||
| Vital Pregnancy Rate | GONAL-F | 33.4 | Percentage of subjects | ||
| Implantation Rate | FE 999049 | 39.8 | Percentage | ||
| Implantation Rate | GONAL-F | 41.3 | Percentage | ||
| Proportion of Subjects With Extreme Ovarian Responses, Defined as <4, ≥15 or ≥20 Oocytes Retrieved | FE 999049 | <4 or >=15 oocytes retrieved | 26.6 | Percentage of subjects | |
| Proportion of Subjects With Extreme Ovarian Responses, Defined as <4, ≥15 or ≥20 Oocytes Retrieved | GONAL-F | <4 or >=15 oocytes retrieved | 31.3 | Percentage of subjects |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FE 999049 | 665 | |
| Overall Study | STARTED | GONAL-F | 661 | |
| Overall Study | COMPLETED | FE 999049 | 630 | |
| Overall Study | COMPLETED | GONAL-F | 639 | |
| Overall Study | NOT COMPLETED | FE 999049 | 35 | |
| Overall Study | NOT COMPLETED | GONAL-F | 22 |
Source ClinicalTrials.gov
Adverse events30
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 | Procedural pain | Injury, poisoning and procedural complications | FE 999049 | 49 | 665 | 51 |
| other | Procedural pain | Injury, poisoning and procedural complications | GONAL-F | 52 | 661 | 54 |
| other | Headache | Nervous system disorders | FE 999049 | 97 | 665 | 131 |
| other | Headache | Nervous system disorders | GONAL-F | 88 | 661 | 110 |
| other | Pelvic pain | Reproductive system and breast disorders | FE 999049 | 46 | 665 | 54 |
| other | Pelvic pain | Reproductive system and breast disorders | GONAL-F | 41 | 661 | 59 |
| other | Pelvic discomfort | Reproductive system and breast disorders | FE 999049 | 38 | 665 | 46 |
| other | Pelvic discomfort | Reproductive system and breast disorders | GONAL-F | 25 | 661 | 31 |
| serious | Post procedural haemorrhage | Injury, poisoning and procedural complications | FE 999049 | 2 | 665 | 2 |
| serious | Post procedural haemorrhage | Injury, poisoning and procedural complications | GONAL-F | 0 | 661 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FE 999049 | ||
| Total, all-cause mortality | GONAL-F | ||
| Total, other adverse events | FE 999049 | 168 | 665 |
| Total, other adverse events | GONAL-F | 159 | 661 |
| Total, serious adverse events | FE 999049 | 16 | 665 |
| Total, serious adverse events | GONAL-F | 10 | 661 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| FE 999049 vs GONAL-F: 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/NCT01956110
GET https://conductscience.org/api/trials/v1/NCT01956110/registered?page=2