Trial · NCT01956123
Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2
NCT01956123, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2018-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2. Trials, record NCT01956123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01956123
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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 2
- NCT number
- NCT01956123
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 513 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Infertility
- Interventions
- Follitropin Delta (FE 999049), Follitropin Alfa (GONAL-F)
- First posted
- 2013-10-08
- Last updated
- 2023-09-06
- Other registries' IDs
- eudract:2013-001616-30
- Results first posted
- 2018-09-21
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles | Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose | The proportion (percentage) of participants with at least one treatment-induced anti-FSH antibody response at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by participants in COS cycle 2 are presented. Participants with observations in both cycles are only counted once. |
| Secondary | Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies With Neutralising Capacity After up to Two Repeated Controlled Ovarian Stimulation Cycles | Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose | The proportion (percentage) of participants with treatment-induced anti-FSH antibodies with neutralising capacity at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by participants in COS cycle 2 are presented. Participants with observations in both cycles are only counted once. |
| Secondary | Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity, After One and After Two Repeated Controlled Ovarian Stimulation Cycles | Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose | The proportion (percentage) of participants with treatment-induced anti-FSH antibodies, overall as well as with neutralising capacity, after one and after two repeated COS cycles is presented. |
| Secondary | Proportion (Percentage) of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS for Each Controlled Ovarian Stimulation Cycle | ≤9 days after triggering of final follicular maturation. | The proportion (percentage) of participants 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 (Percentage) of Subject With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response for Each Controlled Ovarian Stimulation Cycle | End-of-stimulation (up to 20 stimulation days) | Proportion (percentage) of participants with cycle cancellation due to poor ovarian response, excessive ovarian response, and triggering with gonadotropin-releasing hormone (GnRH) agonist are presented. |
| Secondary | Vital Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle | 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 for Each Controlled Ovarian Stimulation Cycle | 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 | Ongoing Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle | 10-11 weeks after blastocyst transfer | Ongoing pregnancy rate was defined as at least one intrauterine viable fetus 10-11 weeks after blastocyst transfer. |
| Secondary | Ongoing Implantation Rate for Each Controlled Ovarian Stimulation Cycle | 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 | Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period for Each Controlled Ovarian Stimulation Cycle | End-of-stimulation (up to 20 stimulation days) | Participants self-assessed injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after each injection. The injection site reactions were assessed as none, mild, moderate and severe. The frequency of injection site reactions (mild, moderate or severe) based on all assessment performed is presented. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles | Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose | Safety analysis set (all exposed participants). | Percentage of participants | NUMBER |
| SECONDARY | Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies With Neutralising Capacity After up to Two Repeated Controlled Ovarian Stimulation Cycles | Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose | Safety analysis set (all exposed participants). | Percentage of participants | NUMBER |
| SECONDARY | Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity, After One and After Two Repeated Controlled Ovarian Stimulation Cycles | Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose | Safety analysis set (all exposed participants). | Percentage of participants | NUMBER |
| SECONDARY | Proportion (Percentage) of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS for Each Controlled Ovarian Stimulation Cycle | ≤9 days after triggering of final follicular maturation. | Modified intention-to-treat (mITT) analysis set (all exposed participants). This is equivalent to the full analysis set (FAS). | Percentage of participants | NUMBER |
| SECONDARY | Proportion (Percentage) of Subject With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response for Each Controlled Ovarian Stimulation Cycle | End-of-stimulation (up to 20 stimulation days) | mITT analysis set (all exposed participants). This is equivalent to the FAS. | Percentage of participants | NUMBER |
| SECONDARY | Vital Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle | 5-6 weeks after blastocyst transfer | mITT analysis set (all exposed participants). This is equivalent to the FAS. | Percentage of participants | NUMBER |
| SECONDARY | Implantation Rate for Each Controlled Ovarian Stimulation Cycle | 5-6 weeks after blastocyst transfer | Participants with blastocyst transfer. In COS cycle 2, a total of 254 and 271 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively. In COS cycle 3, a total of 132 and 121 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively. | Percentage | NUMBER |
| SECONDARY | Ongoing Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle | 10-11 weeks after blastocyst transfer | mITT analysis set (all exposed participants). This is equivalent to FAS. | Percentage of participants | NUMBER |
| SECONDARY | Ongoing Implantation Rate for Each Controlled Ovarian Stimulation Cycle | 10-11 weeks after blastocyst transfer | Participants with blastocyst transfer. In COS cycle 2, a total of 254 and 271 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively. In COS cycle 3, a total of 132 and 121 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively. | Percentage | NUMBER |
| SECONDARY | Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period for Each Controlled Ovarian Stimulation Cycle | End-of-stimulation (up to 20 stimulation days) | Safety analysis set (all exposed participants). | Percentage of events | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles | FE 999049 (COS Cycle 2) | 0.79 | 95% Confidence Interval 0.10 to 2.84 | Percentage of participants | |
| Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles | GONAL-F (COS Cycle 2) | 0.38 | 95% Confidence Interval 0.01 to 2.12 | Percentage of participants | |
| Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies With Neutralising Capacity After up to Two Repeated Controlled Ovarian Stimulation Cycles | FE 999049 (COS Cycle 2) | 0.00 | 95% Confidence Interval 0.00 to 1.45 | Percentage of participants | |
| Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies With Neutralising Capacity After up to Two Repeated Controlled Ovarian Stimulation Cycles | GONAL-F (COS Cycle 2) | 0.00 | 95% Confidence Interval 0.00 to 1.40 | Percentage of participants | |
| Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity, After One and After Two Repeated Controlled Ovarian Stimulation Cycles | FE 999049 (COS Cycle 2) | Treatment-induced anti-FSH antibodies | 0.79 | 95% Confidence Interval 0.10 to 2.84 | Percentage of participants |
| Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity, After One and After Two Repeated Controlled Ovarian Stimulation Cycles | GONAL-F (COS Cycle 2) | Treatment-induced anti-FSH antibodies | 0.38 | 95% Confidence Interval 0.01 to 2.12 | Percentage of participants |
| Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity, After One and After Two Repeated Controlled Ovarian Stimulation Cycles | FE 999049 (COS Cycle 3) | Treatment-induced anti-FSH antibodies | 1.05 | 95% Confidence Interval 0.03 to 5.73 | Percentage of participants |
| Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity, After One and After Two Repeated Controlled Ovarian Stimulation Cycles | GONAL-F (COS Cycle 3) | Treatment-induced anti-FSH antibodies | 1.08 | 95% Confidence Interval 0.03 to 5.85 | Percentage of participants |
| Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity, After One and After Two Repeated Controlled Ovarian Stimulation Cycles | FE 999049 (COS Cycle 2) | Antibodies with neutralising capacity | 0.00 | 95% Confidence Interval 0.00 to 1.45 | Percentage of participants |
| Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity, After One and After Two Repeated Controlled Ovarian Stimulation Cycles | GONAL-F (COS Cycle 2) | Antibodies with neutralising capacity | 0.00 | 95% Confidence Interval 0.00 to 1.40 | Percentage of participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| COS Cycle 2 | STARTED | FE 999049 (COS Cycle 2) | 252 | |
| COS Cycle 2 | STARTED | GONAL-F (COS Cycle 2) | 261 | |
| COS Cycle 2 | STARTED | FE 999049 (COS Cycle 3) | 0 | |
| COS Cycle 2 | STARTED | GONAL-F (COS Cycle 3) | 0 | |
| COS Cycle 2 | COMPLETED | FE 999049 (COS Cycle 2) | 238 | |
| COS Cycle 2 | COMPLETED | GONAL-F (COS Cycle 2) | 254 | |
| COS Cycle 2 | COMPLETED | FE 999049 (COS Cycle 3) | 0 | |
| COS Cycle 2 | COMPLETED | GONAL-F (COS Cycle 3) | 0 | |
| COS Cycle 2 | NOT COMPLETED | FE 999049 (COS Cycle 2) | 14 | |
| COS Cycle 2 | NOT COMPLETED | GONAL-F (COS Cycle 2) | 7 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events52
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 (COS Cycle 2) | 13 | 252 | 14 |
| other | Procedural pain | Injury, poisoning and procedural complications | GONAL-F (COS Cycle 2) | 17 | 261 | 20 |
| other | Procedural pain | Injury, poisoning and procedural complications | FE 999049 (COS Cycle 3) | 5 | 95 | 6 |
| other | Procedural pain | Injury, poisoning and procedural complications | GONAL-F (COS Cycle 3) | 8 | 93 | 8 |
| other | Headache | Nervous system disorders | FE 999049 (COS Cycle 2) | 19 | 252 | 24 |
| other | Headache | Nervous system disorders | GONAL-F (COS Cycle 2) | 27 | 261 | 34 |
| other | Headache | Nervous system disorders | FE 999049 (COS Cycle 3) | 11 | 95 | 12 |
| other | Headache | Nervous system disorders | GONAL-F (COS Cycle 3) | 13 | 93 | 15 |
| other | Biochemical pregnancy | Pregnancy, puerperium and perinatal conditions | FE 999049 (COS Cycle 2) | 13 | 252 | 13 |
| other | Biochemical pregnancy | Pregnancy, puerperium and perinatal conditions | GONAL-F (COS Cycle 2) | 8 | 261 | 8 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FE 999049 (COS Cycle 2) | 0 | 252 |
| Total, all-cause mortality | GONAL-F (COS Cycle 2) | 0 | 261 |
| Total, all-cause mortality | FE 999049 (COS Cycle 3) | 0 | 95 |
| Total, all-cause mortality | GONAL-F (COS Cycle 3) | 0 | 93 |
| Total, other adverse events | FE 999049 (COS Cycle 2) | 70 | 252 |
| Total, other adverse events | GONAL-F (COS Cycle 2) | 77 | 261 |
| Total, other adverse events | FE 999049 (COS Cycle 3) | 26 | 95 |
| Total, other adverse events | GONAL-F (COS Cycle 3) | 34 | 93 |
| Total, serious adverse events | FE 999049 (COS Cycle 2) | 4 | 252 |
| Total, serious adverse events | GONAL-F (COS Cycle 2) | 4 | 261 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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 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.
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Read this trial from software.
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