Trial · NCT03809429
Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)
NCT03809429, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2024-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND). Trials, record NCT03809429. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03809429
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)
- NCT number
- NCT03809429
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 437 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Infertility, Female
- Interventions
- FE 999049 + GnRH agonist (GONAPEPTYL), FE 999049 + GnRH antagonist (CETROTIDE)
- First posted
- 2019-01-18
- Last updated
- 2024-05-13
- Other registries' IDs
- eudract:2017-002783-40
- Results first posted
- 2024-05-13
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Oocytes Retrieved | On day of oocyte retrieval (up to 22 days after start of stimulation) | The number of oocytes retrieved was recorded at the oocyte retrieval visit. |
| Secondary | Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response | At end-of-stimulation (up to 20 days) | For each participant, the reason for cycle cancellation was recorded |
| Secondary | Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS) | At end of transfer (up to 4 weeks) | For each participant, the reason for blastocyst transfer cancellation was recorded. |
| Secondary | Number of Follicles | On stimulation day 6 and at end-of-stimulation (up to 20 days) | The total number of follicles and the number of follicles per size category will be reported |
| Secondary | Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved | On day of oocyte retrieval (up to 22 days after start of stimulation) | Grouped according to number of oocytes |
| Secondary | Number of Metaphase II Oocytes | On day of oocyte retrieval (up to 22 days after start of stimulation) | Only applicable for those inseminated using ICSI |
| Secondary | Fertilization Rate | On day 1 after oocyte retrieval (up to 23 days after start of stimulation) | Measured by the number of pronuclei. Fertilized oocytes with 2 pronuclei were regarded as correctly fertilized |
| Secondary | Number of Embryos | On day 3 after oocyte retrieval (up to 25 days after start of stimulation) | The number of embryos (total and good-quality) was reported. Embryo quality is determined by combined assessment of cleavage stage (number of blastomeres/compaction status) and embryo morphology parameters |
| Secondary | Number of Blastocysts | On day 5 after oocyte retrieval (up to 27 days after start of stimulation) | The number of blastocysts (total and good-quality) was reported. Blastocyst quality is assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring is based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells) |
| Secondary | Circulating Concentrations of Follicle-stimulating Hormone (FSH) | On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) | Blood samples for analysis of circulating concentrations of FSH were drawn. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
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 | On day of oocyte retrieval (up to 22 days after start of stimulation) | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Oocytes | MEAN |
| SECONDARY | Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response | At end-of-stimulation (up to 20 days) | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | participants | NUMBER |
| SECONDARY | Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS) | At end of transfer (up to 4 weeks) | Participants analyzed for this endpoint represent participants with blastocyst transfer cancellation. | participants | NUMBER |
| SECONDARY | Number of Follicles | On stimulation day 6 and at end-of-stimulation (up to 20 days) | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Number of follicles | MEAN |
| SECONDARY | Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved | On day of oocyte retrieval (up to 22 days after start of stimulation) | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Metaphase II Oocytes | On day of oocyte retrieval (up to 22 days after start of stimulation) | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | MII oocytes | MEAN |
| SECONDARY | Fertilization Rate | On day 1 after oocyte retrieval (up to 23 days after start of stimulation) | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | percentage of fertilized oocytes | MEAN |
| SECONDARY | Number of Embryos | On day 3 after oocyte retrieval (up to 25 days after start of stimulation) | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Embryos | MEAN |
| SECONDARY | Number of Blastocysts | On day 5 after oocyte retrieval (up to 27 days after start of stimulation) | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Blastocysts | MEAN |
| SECONDARY | Circulating Concentrations of Follicle-stimulating Hormone (FSH) | On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | IU/L | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group126
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 + GnRH Agonist (GONAPEPTYL) | 11.1 | Standard Deviation 5.9 | Oocytes | |
| Number of Oocytes Retrieved | FE 999049 + GnRH Antagonist (CETROTIDE) | 9.6 | Standard Deviation 5.5 | Oocytes | |
| Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response | FE 999049 + GnRH Agonist (GONAPEPTYL) | Excessive response | 2 | participants | |
| Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response | FE 999049 + GnRH Antagonist (CETROTIDE) | Excessive response | 3 | participants | |
| Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response | FE 999049 + GnRH Agonist (GONAPEPTYL) | Poor response | 1 | participants | |
| Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response | FE 999049 + GnRH Antagonist (CETROTIDE) | Poor response | 3 | participants | |
| Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response | FE 999049 + GnRH Agonist (GONAPEPTYL) | Other reason | 1 | participants | |
| Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response | FE 999049 + GnRH Antagonist (CETROTIDE) | Other reason | 1 | participants | |
| Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS) | FE 999049 + GnRH Agonist (GONAPEPTYL) | Transfer cancellation | 27 | participants | |
| Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS) | FE 999049 + GnRH Antagonist (CETROTIDE) | Transfer cancellation | 30 | participants |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 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 + GnRH Agonist (GONAPEPTYL) | 220 | |
| Overall Study | STARTED | FE 999049 + GnRH Antagonist (CETROTIDE) | 215 | |
| Overall Study | COMPLETED | FE 999049 + GnRH Agonist (GONAPEPTYL) | 192 | |
| Overall Study | COMPLETED | FE 999049 + GnRH Antagonist (CETROTIDE) | 195 | |
| Overall Study | NOT COMPLETED | FE 999049 + GnRH Agonist (GONAPEPTYL) | 28 | |
| Overall Study | NOT COMPLETED | FE 999049 + GnRH Antagonist (CETROTIDE) | 20 |
Source ClinicalTrials.gov
Adverse events20
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 + GnRH Agonist (GONAPEPTYL) | 20 | 202 | 20 |
| other | Procedural pain | Injury, poisoning and procedural complications | FE 999049 + GnRH Antagonist (CETROTIDE) | 12 | 204 | 12 |
| other | Headache | Nervous system disorders | FE 999049 + GnRH Agonist (GONAPEPTYL) | 27 | 202 | 31 |
| other | Headache | Nervous system disorders | FE 999049 + GnRH Antagonist (CETROTIDE) | 29 | 204 | 30 |
| other | Biochemical pregnancy | Pregnancy, puerperium and perinatal conditions | FE 999049 + GnRH Agonist (GONAPEPTYL) | 10 | 202 | 10 |
| other | Biochemical pregnancy | Pregnancy, puerperium and perinatal conditions | FE 999049 + GnRH Antagonist (CETROTIDE) | 11 | 204 | 11 |
| other | Pelvic pain | Reproductive system and breast disorders | FE 999049 + GnRH Agonist (GONAPEPTYL) | 14 | 202 | 15 |
| other | Pelvic pain | Reproductive system and breast disorders | FE 999049 + GnRH Antagonist (CETROTIDE) | 11 | 204 | 12 |
| other | Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | FE 999049 + GnRH Agonist (GONAPEPTYL) | 12 | 202 | 12 |
| other | Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | FE 999049 + GnRH Antagonist (CETROTIDE) | 11 | 204 | 11 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FE 999049 + GnRH Agonist (GONAPEPTYL) | 0 | 202 |
| Total, all-cause mortality | FE 999049 + GnRH Antagonist (CETROTIDE) | 0 | 204 |
| Total, other adverse events | FE 999049 + GnRH Agonist (GONAPEPTYL) | 68 | 202 |
| Total, other adverse events | FE 999049 + GnRH Antagonist (CETROTIDE) | 69 | 204 |
| Total, serious adverse events | FE 999049 + GnRH Agonist (GONAPEPTYL) | 4 | 202 |
| Total, serious adverse events | FE 999049 + GnRH Antagonist (CETROTIDE) | 6 | 204 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38723189 | DERIVED |
Source PubMed
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FE 999049 + GnRH Agonist (GONAPEPTYL) vs FE 999049 + GnRH Antagonist (CETROTIDE): Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) | Trial comparisons |
| FE 999049 + GnRH Agonist (GONAPEPTYL) vs FE 999049 + GnRH Antagonist (CETROTIDE): Proportion of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade) | Trial comparisons |
| FE 999049 + GnRH Agonist (GONAPEPTYL) vs FE 999049 + GnRH Antagonist (CETROTIDE): Frequency of Adverse Events | Trial comparisons |
| FE 999049 + GnRH Agonist (GONAPEPTYL) vs FE 999049 + GnRH Antagonist (CETROTIDE): Technical Malfunctions of the Pre-filled Injection Pen | Trial comparisons |
| FE 999049 + GnRH Agonist (GONAPEPTYL) vs FE 999049 + GnRH Antagonist (CETROTIDE): deaths from any cause | Trial comparisons |
| FE 999049 + GnRH Agonist (GONAPEPTYL) vs FE 999049 + GnRH Antagonist (CETROTIDE): 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/NCT03809429
GET https://conductscience.org/api/trials/v1/NCT03809429/registered?page=2