Trial · NCT03296527
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women
NCT03296527, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2021-06-01
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 Pan-Asian Women. Trials, record NCT03296527. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03296527
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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 Pan-Asian Women
- NCT number
- NCT03296527
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,011 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Controlled Ovarian Simulation
- Interventions
- Follitropin alfa, Follitropin delta
- First posted
- 2017-09-28
- Last updated
- 2023-08-24
- Results first posted
- 2021-06-01
Source ClinicalTrials.gov
Registered outcomes61
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 transfer | Defined as at least one intrauterine viable fetus 10-11 weeks after transfer. |
| Secondary | Positive Beta Unit of Human Chorionic Gonadotropin (βhCG) Rate | 13-15 days after transfer | Defined as positive βhCG test 13-15 days after transfer. |
| Secondary | Clinical Pregnancy Rate | 5-6 weeks after transfer | Defined as at least one gestational sac 5-6 weeks after transfer. |
| Secondary | Vital Pregnancy Rate | 5-6 weeks after transfer | 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 | Defined as number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred. |
| Secondary | Ongoing Implantation Rate | 10-11 weeks after transfer | Defined as number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of embryos transferred. |
| Secondary | Proportion of Subjects With Extreme Ovarian Responses | Oocyte retrieval visit | Extreme ovarian response defined as \<4, ≥15 or ≥ 20 oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included as \<4 oocytes retrieved. |
| Secondary | Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS | Up to 9 days after triggering of final follicular maturation | Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe. |
| Secondary | Proportion of Subjects With Cycle Cancellation Due to Poor or Excessive Ovarian Response or Embryo Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk | End-of-stimulation visit (up to 20 days) or transfer visit | For each participant the reason for each cycle cancellation was recorded. Embryo transfer cancellation due to adverse events, such as ovarian hyperfunction, OHSS and progesterone increased in participants with embryos available for transfer, were considered as transfer cancellations due to excessive response / OHSS risk. |
| Secondary | Number of Follicles on Stimulation Day 6 | On stimulation Day 6 | Counted by ultrasound for the right and left ovary for each participant. |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 registered outcomesOutcomes61
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 transfer | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Positive Beta Unit of Human Chorionic Gonadotropin (βhCG) Rate | 13-15 days after transfer | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Clinical Pregnancy Rate | 5-6 weeks after transfer | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Vital Pregnancy Rate | 5-6 weeks after transfer | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Implantation Rate | 5-6 weeks after transfer | Participants with embryo transfer (a total of 548 and 546 embryos were transferred in the FE 999049 and GONAL-F groups, respectively). The experimental unit was transferred embryo. | percentage of sacs/embryos transferred | NUMBER |
| SECONDARY | Ongoing Implantation Rate | 10-11 weeks after transfer | Participants with embryo transfer (a total of 548 and 546 embryos were transferred in the FE 999049 and GONAL-F groups, respectively). The experimental unit was transferred embryos. | % of viable fetus/embryos transferred | NUMBER |
| SECONDARY | Proportion of Subjects With Extreme Ovarian Responses | Oocyte retrieval visit | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with oocytes retrieved and participants with cycle cancellation due to poor ovarian response. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS | Up to 9 days after triggering of final follicular maturation | The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Subjects With Cycle Cancellation Due to Poor or Excessive Ovarian Response or Embryo Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk | End-of-stimulation visit (up to 20 days) or transfer visit | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Number of Follicles on Stimulation Day 6 | On stimulation Day 6 | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | number of follicles | MEAN |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 outcomesResults by group242
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 000049 (Follitropin Delta) | 31.3 | percentage of participants | ||
| Ongoing Pregnancy Rate | GONAL-F (Follitropin Alfa) | 25.7 | percentage of participants | ||
| Positive Beta Unit of Human Chorionic Gonadotropin (βhCG) Rate | FE 000049 (Follitropin Delta) | 41.7 | percentage of participants | ||
| Positive Beta Unit of Human Chorionic Gonadotropin (βhCG) Rate | GONAL-F (Follitropin Alfa) | 35.3 | percentage of participants | ||
| Clinical Pregnancy Rate | FE 000049 (Follitropin Delta) | 36.1 | percentage of participants | ||
| Clinical Pregnancy Rate | GONAL-F (Follitropin Alfa) | 31.2 | percentage of participants | ||
| Vital Pregnancy Rate | FE 000049 (Follitropin Delta) | 32.3 | percentage of participants | ||
| Vital Pregnancy Rate | GONAL-F (Follitropin Alfa) | 28.0 | percentage of participants | ||
| Implantation Rate | FE 000049 (Follitropin Delta) | 35.6 | percentage of sacs/embryos transferred | ||
| Implantation Rate | GONAL-F (Follitropin Alfa) | 31.3 | percentage of sacs/embryos transferred |
1 to 10 of 242Source ClinicalTrials.gov
See all 242 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FE 000049 (Follitropin Delta) | 500 | |
| Overall Study | STARTED | GONAL-F (Follitropin Alfa) | 511 | |
| Overall Study | Full Analysis Set | FE 000049 (Follitropin Delta) | 499 | |
| Overall Study | Full Analysis Set | GONAL-F (Follitropin Alfa) | 510 | |
| Overall Study | COMPLETED | FE 000049 (Follitropin Delta) | 465 | |
| Overall Study | COMPLETED | GONAL-F (Follitropin Alfa) | 458 | |
| Overall Study | NOT COMPLETED | FE 000049 (Follitropin Delta) | 35 | |
| Overall Study | NOT COMPLETED | GONAL-F (Follitropin Alfa) | 53 |
Source ClinicalTrials.gov
Adverse events34
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 | Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | FE 000049 (Follitropin Delta) | 29 | 499 | 29 |
| other | Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | GONAL-F (Follitropin Alfa) | 35 | 510 | 35 |
| other | Pelvic discomfort | Reproductive system and breast disorders | FE 000049 (Follitropin Delta) | 25 | 499 | 26 |
| other | Pelvic discomfort | Reproductive system and breast disorders | GONAL-F (Follitropin Alfa) | 28 | 510 | 30 |
| other | Biochemical pregnancy | Pregnancy, puerperium and perinatal conditions | FE 000049 (Follitropin Delta) | 25 | 499 | 25 |
| other | Biochemical pregnancy | Pregnancy, puerperium and perinatal conditions | GONAL-F (Follitropin Alfa) | 21 | 510 | 21 |
| other | Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | FE 000049 (Follitropin Delta) | 25 | 499 | 25 |
| other | Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | GONAL-F (Follitropin Alfa) | 18 | 510 | 20 |
| serious | Enteritis | Gastrointestinal disorders | FE 000049 (Follitropin Delta) | 1 | 499 | 1 |
| serious | Enteritis | Gastrointestinal disorders | GONAL-F (Follitropin Alfa) | 0 | 510 | 0 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FE 000049 (Follitropin Delta) | 0 | 499 |
| Total, all-cause mortality | GONAL-F (Follitropin Alfa) | 0 | 510 |
| Total, other adverse events | FE 000049 (Follitropin Delta) | 97 | 499 |
| Total, other adverse events | GONAL-F (Follitropin Alfa) | 94 | 510 |
| Total, serious adverse events | FE 000049 (Follitropin Delta) | 30 | 499 |
| Total, serious adverse events | GONAL-F (Follitropin Alfa) | 18 | 510 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FE 000049 (Follitropin Delta) vs GONAL-F (Follitropin Alfa): deaths from any cause | Trial comparisons |
| FE 000049 (Follitropin Delta) vs GONAL-F (Follitropin Alfa): 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/NCT03296527
GET https://conductscience.org/api/trials/v1/NCT03296527/registered?page=2