Primary outcomeMean· On day of oocyte retrieval (up to 22 days after start of stimulation)
Number of Oocytes Retrieved
| Group | Value (Oocytes) | Spread |
|---|---|---|
| FE 999049 + GnRH Agonist (GONAPEPTYL) | 11.1 | 5.9 |
| FE 999049 + GnRH Antagonist (CETROTIDE) | 9.6 | 5.5 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataFollitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)
Short name BEYOND
NCTNCT03809429 (opens ClinicalTrials.gov in a new tab)Other id000304Other id2017-002783-40Other id2017
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 437 participants (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Design
- Randomized · Open label (no masking)
- Countries
7 countries
Austria, Denmark, Israel, Italy, Netherlands, Norway, Switzerland
- Start
- 29 Apr 2019
- Primary completion
- 16 Feb 2022
- Completion
- 16 Feb 2022
- First posted
- 18 Jan 2019
- Last update posted
- 13 May 2024
- Conditions
- Infertility, Female
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20192020202120222023
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
To compare the efficacy and safety of FE 999049 (follitropin delta) and its personalized dosing algorithm in controlled ovarian stimulation for in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) using a long gonadotropin-releasing hormone (GnRH) agonist protocol versus a short GnRH antagonist protocol.
Interventions
- FE 999049 + GnRH agonist (GONAPEPTYL)Drug
- FE 999049 + GnRH antagonist (CETROTIDE)Drug
Arms2
Experimental
FE 999049 + GnRH agonist (GONAPEPTYL)
Active comparator
FE 999049 + GnRH antagonist (CETROTIDE)
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Oocytes Retrieved
Time frame · On day of oocyte retrieval (up to 22 days after start of stimulation)
Registry description
The number of oocytes retrieved was recorded at the oocyte retrieval visit.
Secondary outcomes(20)
Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response
Time frame · At end-of-stimulation (up to 20 days)
Registry description
For each participant, the reason for cycle cancellation was recorded
Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS)
Time frame · At end of transfer (up to 4 weeks)
Registry description
For each participant, the reason for blastocyst transfer cancellation was recorded.
Number of Follicles
Time frame · On stimulation day 6 and at end-of-stimulation (up to 20 days)
Registry description
The total number of follicles and the number of follicles per size category will be reported
Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
Time frame · On day of oocyte retrieval (up to 22 days after start of stimulation)
Registry description
Grouped according to number of oocytes
Number of Metaphase II Oocytes
Time frame · On day of oocyte retrieval (up to 22 days after start of stimulation)
Registry description
Only applicable for those inseminated using ICSI
Fertilization Rate
Time frame · On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Registry description
Measured by the number of pronuclei. Fertilized oocytes with 2 pronuclei were regarded as correctly fertilized
Number of Embryos
Time frame · On day 3 after oocyte retrieval (up to 25 days after start of stimulation)
Registry description
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
Number of Blastocysts
Time frame · On day 5 after oocyte retrieval (up to 27 days after start of stimulation)
Registry description
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)
Circulating Concentrations of Follicle-stimulating Hormone (FSH)
Time frame · 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)
Registry description
Blood samples for analysis of circulating concentrations of FSH were drawn.
Circulating Concentrations of Luteinizing Hormone (LH)
Time frame · 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)
Registry description
Blood samples for analysis of circulating concentrations of LH were drawn
Circulating Concentrations of Estradiol
Time frame · 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)
Registry description
Blood samples for analysis of circulating concentrations of estradiol were drawn
Circulating Concentrations of Progesterone
Time frame · 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)
Registry description
Blood samples for analysis of circulating concentrations of progesterone were drawn
Circulating Concentrations of Inhibin B
Time frame · 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)
Registry description
Blood samples for analysis of circulating concentrations of Inhibin B were drawn
Total Gonadotropin Dose
Time frame · Up to 20 days
Registry description
Calculated by start dates, end dates and daily dose of investigational medicinal product
Number of Stimulation Days
Time frame · Up to 20 days
Registry description
Calculated by start dates and end dates
Positive Beta Human Chorionic Gonadotropin (βhCG) Rate
Time frame · 13-15 days after transfer (up to approximately 1.5 months after start of stimulation)
Registry description
Defined as positive serum βhCG test
Implantation Rate
Time frame · 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)
Registry description
Defined as the number of gestational sacs after transfer divided by number of blastocysts transferred
Clinical Pregnancy Rate
Time frame · 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)
Registry description
Defined as at least one gestational sac
Vital Pregnancy Rate
Time frame · 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)
Registry description
Defined as at least one intrauterine gestational sac with fetal heart beat
Ongoing Pregnancy Rate
Time frame · 10-11 weeks after transfer (up to approximately 4 months after start of stimulation)
Registry description
At least one intrauterine viable fetus
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeNumber· At end-of-stimulation (up to 20 days)
Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response
| Group | Value (participants) |
|---|---|
| FE 999049 + GnRH Agonist (GONAPEPTYL) | 2 |
| FE 999049 + GnRH Antagonist (CETROTIDE) | 3 |
Secondary outcomeNumber· At end of transfer (up to 4 weeks)
Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS)
| Group | Value (participants) |
|---|---|
| FE 999049 + GnRH Agonist (GONAPEPTYL) | 27 |
| FE 999049 + GnRH Antagonist (CETROTIDE) | 30 |
Secondary outcomeMean· On stimulation day 6 and at end-of-stimulation (up to 20 days)
Number of Follicles
| Group | Value (Number of follicles) | Spread |
|---|---|---|
| FE 999049 + GnRH Agonist (GONAPEPTYL) | 15.2 | 6.3 |
| FE 999049 + GnRH Antagonist (CETROTIDE) | 14.9 | 6.3 |
Secondary outcomeCount of participants· On day of oocyte retrieval (up to 22 days after start of stimulation)
Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
| Group | Value (Participants) |
|---|---|
| FE 999049 + GnRH Agonist (GONAPEPTYL) | 13 |
| FE 999049 + GnRH Antagonist (CETROTIDE) | 26 |
Secondary outcomeMean· On day of oocyte retrieval (up to 22 days after start of stimulation)
Number of Metaphase II Oocytes
| Group | Value (MII oocytes) | Spread |
|---|---|---|
| FE 999049 + GnRH Agonist (GONAPEPTYL) | 9.2 | 4.8 |
| FE 999049 + GnRH Antagonist (CETROTIDE) | 7.9 | 4.7 |
Secondary outcomeMean· On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Fertilization Rate
| Group | Value (percentage of fertilized oocytes) | Spread |
|---|---|---|
| FE 999049 + GnRH Agonist (GONAPEPTYL) | 53.8 | 24.1 |
| FE 999049 + GnRH Antagonist (CETROTIDE) | 54.4 | 26.8 |
Secondary outcomeMean· On day 3 after oocyte retrieval (up to 25 days after start of stimulation)
Number of Embryos
| Group | Value (Embryos) | Spread |
|---|---|---|
| FE 999049 + GnRH Agonist (GONAPEPTYL) | 5.7 | 3.9 |
| FE 999049 + GnRH Antagonist (CETROTIDE) | 5.0 | 3.9 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| FE 999049 + GnRH Agonist (GONAPEPTYL)FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | 0 / 202 | 4 / 202 | 68 / 202 |
| FE 999049 + GnRH Antagonist (CETROTIDE)FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection | 0 / 204 | 6 / 204 | 69 / 204 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedLobo R, Soerdal T, Ekerhovd E, Cohlen B, Porcu E, Schenk M, Shufaro Y, Smeenk J, Suerdieck MB, Pinton P, Pinborg A; BEYOND Investigators. BEYOND: a randomized controlled trial comparing efficacy and safety of individualized follitropin delta dosing in a GnRH agonist versus antagonist protocol during the first ovarian stimulation cycle. Hum Reprod. 2024 May 9;39(7):1481-94. doi: 10.1093/humrep/deae092. Online ahead of print. PMID 38723189
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 40 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Infertile women aged 18-40 undergoing their first IVF/ICSI cycle that are in good physical and mental health and that have been diagnosed with problems in the fallopian tubes, mild endometriosis or have partners with decreased sperm quality.
* The participants must have a regular menstrual cycle, a normal uterus and 2 normal ovaries.
* The allowed body mass index is 17.5-32 Kg/m\^2.
Exclusion Criteria:
* Women with very high ovarian reserve, strong preference for either treatment, severe endometriosis, history of repeated miscarriage, couples with known problems in the chromosomes, history or high risk of producing blood cloths, women known to have chronic diseases, women recently participating in trials with non-registered drugs.
PepBank is a research reference. Talk to a doctor before you use any peptide.