Trial · NCT03228680
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women
NCT03228680, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2021-03-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women. Trials, record NCT03228680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03228680
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women
- NCT number
- NCT03228680
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 373 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Infertility
- Interventions
- Follitropin delta, Follitropin beta
- First posted
- 2017-07-25
- Last updated
- 2023-08-24
- Results first posted
- 2021-03-24
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Oocytes Retrieved | 36h (± 2h) after triggering of final follicular maturation (On day of oocyte retrieval) | The number of oocytes retrieved was recorded at the oocyte retrieval visit. |
| Secondary | Clinical Pregnancy Rate | 5-6 weeks after transfer (up to approximately 3 months after start of stimulation) | Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer. |
| Secondary | Positive Beta Unit of Human Chorionic Gonadotropin (Beta-hCG) Rate | 13-15 days after transfer (up to approximately 1.5 months after start of stimulation) | Defined as positive serum beta-hCG test 13-15 days after transfer. |
| Secondary | Vital Pregnancy Rate | 5-6 weeks after transfer (up to approximately 3 months after start of stimulation) | Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer. |
| Secondary | Implantation Rate | 5-6 weeks after transfer (up to approximately 3 months after start of stimulation) | Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by the number of blastocysts transferred. |
| Secondary | Proportion of Participants With Cycle Cancellation Due to Poor or Excessive Ovarian Response | End-of-stimulation (up to 20 stimulation days) | |
| Secondary | Proportion of Participants With Blastocyst Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk | End-of-stimulation (up to 20 stimulation days) | |
| Secondary | Proportion of Participants With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved | On the day of oocyte retrieval (up to 22 days after start of stimulation) | Defined as proportion of participants grouped according to the number of oocytes retrieved. The proportion of participants with \<4 oocytes (low response), 4-7 oocytes (moderate response), 8-14 oocytes (targeted response), 15-19 oocytes (hyperresponse) and ≥20 oocytes (severe hyperresponse) are presented. |
| Secondary | Proportion of Participants With Extreme Ovarian Responses (Defined as <4, ≥15 or ≥20 Oocytes Retrieved) in Risk Population | On the day of oocyte retrieval (up to 22 days after start of stimulation) | |
| Secondary | Proportion of Participants With Preventive Interventions for Early Ovarian Hyperstimulation Syndrome (OHSS) | ≤9 days after triggering of final follicular maturation |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Oocytes Retrieved | 36h (± 2h) after triggering of final follicular maturation (On day of oocyte retrieval) | The full analysis set (FAS) comprised all randomized and exposed participants. | Oocytes retrieved | MEAN |
| SECONDARY | Clinical Pregnancy Rate | 5-6 weeks after transfer (up to approximately 3 months after start of stimulation) | The FAS comprised of all randomized and exposed participants. | percentage of participants | NUMBER |
| SECONDARY | Positive Beta Unit of Human Chorionic Gonadotropin (Beta-hCG) Rate | 13-15 days after transfer (up to approximately 1.5 months after start of stimulation) | The FAS comprised of all randomized and exposed participants. | percentage of participants | NUMBER |
| SECONDARY | Vital Pregnancy Rate | 5-6 weeks after transfer (up to approximately 3 months after start of stimulation) | The FAS comprised of all randomized and exposed participants. | percentage of participants | NUMBER |
| SECONDARY | Implantation Rate | 5-6 weeks after transfer (up to approximately 3 months after start of stimulation) | The FAS comprised of all randomized and exposed participants with blastocyst transfer. | % of sacs/blastocysts transferred | NUMBER |
| SECONDARY | Proportion of Participants With Cycle Cancellation Due to Poor or Excessive Ovarian Response | End-of-stimulation (up to 20 stimulation days) | The FAS comprised of all randomized and exposed participants. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants With Blastocyst Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk | End-of-stimulation (up to 20 stimulation days) | The FAS comprised of all randomized and exposed participants. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved | On the day of oocyte retrieval (up to 22 days after start of stimulation) | The FAS comprised of all randomized and exposed participants. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants With Extreme Ovarian Responses (Defined as <4, ≥15 or ≥20 Oocytes Retrieved) in Risk Population | On the day of oocyte retrieval (up to 22 days after start of stimulation) | The FAS comprised of all randomized and exposed participants. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants With Preventive Interventions for Early Ovarian Hyperstimulation Syndrome (OHSS) | ≤9 days after triggering of final follicular maturation | The FAS comprised of all participants randomized or exposed. | percentage of participants | NUMBER |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group156
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Oocytes Retrieved | FE 999049 (Follitropin Delta) | 9.3 | Standard Deviation 5.4 | Oocytes retrieved | |
| Number of Oocytes Retrieved | FOLLISTIM (Follitropin Beta) | 10.5 | Standard Deviation 6.1 | Oocytes retrieved | |
| Clinical Pregnancy Rate | FE 999049 (Follitropin Delta) | 25.3 | percentage of participants | ||
| Clinical Pregnancy Rate | FOLLISTIM (Follitropin Beta) | 23.7 | percentage of participants | ||
| Positive Beta Unit of Human Chorionic Gonadotropin (Beta-hCG) Rate | FE 999049 (Follitropin Delta) | 29.4 | percentage of participants | ||
| Positive Beta Unit of Human Chorionic Gonadotropin (Beta-hCG) Rate | FOLLISTIM (Follitropin Beta) | 29.4 | percentage of participants | ||
| Vital Pregnancy Rate | FE 999049 (Follitropin Delta) | 23.5 | percentage of participants | ||
| Vital Pregnancy Rate | FOLLISTIM (Follitropin Beta) | 21.5 | percentage of participants | ||
| Implantation Rate | FE 999049 (Follitropin Delta) | 31.9 | % of sacs/blastocysts transferred | ||
| Implantation Rate | FOLLISTIM (Follitropin Beta) | 29.8 | % of sacs/blastocysts transferred |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 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 (Follitropin Delta) | 170 | |
| Overall Study | STARTED | FOLLISTIM (Follitropin Beta) | 178 | |
| Overall Study | COMPLETED | FE 999049 (Follitropin Delta) | 147 | |
| Overall Study | COMPLETED | FOLLISTIM (Follitropin Beta) | 143 | |
| Overall Study | NOT COMPLETED | FE 999049 (Follitropin Delta) | 23 | |
| Overall Study | NOT COMPLETED | FOLLISTIM (Follitropin Beta) | 35 |
Source ClinicalTrials.gov
Adverse events26
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 | Constipation | Gastrointestinal disorders | FE 999049 (Follitropin Delta) | 4 | 170 | 4 |
| other | Constipation | Gastrointestinal disorders | FOLLISTIM (Follitropin Beta) | 5 | 177 | 6 |
| other | Injection site erythema | General disorders | FE 999049 (Follitropin Delta) | 13 | 170 | 14 |
| other | Injection site erythema | General disorders | FOLLISTIM (Follitropin Beta) | 15 | 177 | 15 |
| other | Injection site pruritus | General disorders | FE 999049 (Follitropin Delta) | 0 | 170 | 0 |
| other | Injection site pruritus | General disorders | FOLLISTIM (Follitropin Beta) | 5 | 177 | 5 |
| other | Viral upper respiratory tract infection | Infections and infestations | FE 999049 (Follitropin Delta) | 6 | 170 | 6 |
| other | Viral upper respiratory tract infection | Infections and infestations | FOLLISTIM (Follitropin Beta) | 6 | 177 | 6 |
| other | Headache | Nervous system disorders | FE 999049 (Follitropin Delta) | 4 | 170 | 4 |
| other | Headache | Nervous system disorders | FOLLISTIM (Follitropin Beta) | 4 | 177 | 4 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FE 999049 (Follitropin Delta) | 0 | 170 |
| Total, all-cause mortality | FOLLISTIM (Follitropin Beta) | 0 | 177 |
| Total, other adverse events | FE 999049 (Follitropin Delta) | 73 | 170 |
| Total, other adverse events | FOLLISTIM (Follitropin Beta) | 92 | 177 |
| Total, serious adverse events | FE 999049 (Follitropin Delta) | 0 | 170 |
| Total, serious adverse events | FOLLISTIM (Follitropin Beta) | 2 | 177 |
Source ClinicalTrials.gov
Papers3
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FE 999049 (Follitropin Delta) vs FOLLISTIM (Follitropin Beta): Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-stimulation | Trial comparisons |
| FE 999049 (Follitropin Delta) vs FOLLISTIM (Follitropin Beta): deaths from any cause | Trial comparisons |
| FE 999049 (Follitropin Delta) vs FOLLISTIM (Follitropin Beta): Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-trial | Trial comparisons |
| FE 999049 (Follitropin Delta) vs FOLLISTIM (Follitropin Beta): 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/NCT03228680
GET https://conductscience.org/api/trials/v1/NCT03228680/registered?page=2