Who is sponsoring NCT03809429?

NCT03809429 is sponsored by Ferring Pharmaceuticals.

What drugs are being tested in NCT03809429?

Interventions in NCT03809429: FE 999049 + GnRH agonist (GONAPEPTYL), FE 999049 + GnRH antagonist (CETROTIDE).

What condition does NCT03809429 study?

NCT03809429 studies Infertility, Female.

Is NCT03809429 still recruiting?

NCT03809429 is currently completed. Last updated 13 May 2024.

Are results published for NCT03809429?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-05-13 · How we verify

NCT03809429: BEYOND

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)

Completed Phase 3 Results posted Last updated 13 May 2024

What this trial tests

Phase 3 trial testing FE 999049 + GnRH agonist (GONAPEPTYL) in Infertility, Female in 437 participants. Completed in 16 February 2022.

Timeline

29 April 2019

Primary endpoint
16 February 2022

16 February 2022

Quick facts

Lead sponsor	Ferring Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	437
Start date	29 April 2019
Primary completion	16 February 2022
Estimated completion	16 February 2022
Sites	16 locations across Italy, Denmark, Netherlands, Austria, Israel, Norway, Switzerland

Drugs / interventions tested

FE 999049 + GnRH agonist (GONAPEPTYL) — full drug profile →
FE 999049 + GnRH antagonist (CETROTIDE) — full drug profile →

Conditions studied

Infertility, Female — all drugs for Infertility, Female →

Sponsor

Ferring Pharmaceuticals — full company profile →

Who can join

Adults 18 to 40, female only, with Infertility, Female. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Oocytes Retrieved Primary · 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.

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	11.1	± 5.9
FE 999049 + GnRH Antagonist (CETROTIDE)	9.6	± 5.5

Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response Secondary · At end-of-stimulation (up to 20 days)

For each participant, the reason for cycle cancellation was recorded

Excessive response

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	2
FE 999049 + GnRH Antagonist (CETROTIDE)	3

Poor response

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	1
FE 999049 + GnRH Antagonist (CETROTIDE)	3

Other reason

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	1
FE 999049 + GnRH Antagonist (CETROTIDE)	1

Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS) Secondary · At end of transfer (up to 4 weeks)

For each participant, the reason for blastocyst transfer cancellation was recorded.

Transfer cancellation

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	27
FE 999049 + GnRH Antagonist (CETROTIDE)	30

Reason for transfer cancellation: Adverse Event

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	5
FE 999049 + GnRH Antagonist (CETROTIDE)	8

Reason for transfer cancellation: Risk of OHSS

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	1
FE 999049 + GnRH Antagonist (CETROTIDE)	1

Reason for transfer cancellation: No blastocyst

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	13
FE 999049 + GnRH Antagonist (CETROTIDE)	18

Reason for transfer cancellation: COVID-19

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	3
FE 999049 + GnRH Antagonist (CETROTIDE)	1

Reason for transfer cancellation: Other reason

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	5
FE 999049 + GnRH Antagonist (CETROTIDE)	2

Number of Follicles Secondary · 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

Total number of follicles at Stimulation Day 6

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	15.2	± 6.3
FE 999049 + GnRH Antagonist (CETROTIDE)	14.9	± 6.3

Follicles >= 10 mm at Stimulation Day 6

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	4.6	± 4.3
FE 999049 + GnRH Antagonist (CETROTIDE)	7.1	± 3.6

Follicles >= 12 mm at Stimulation Day 6

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	1.6	± 2.7
FE 999049 + GnRH Antagonist (CETROTIDE)	3.8	± 2.9

Total number of follicles at End-of-stimulation visit

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	18.3	± 7.1
FE 999049 + GnRH Antagonist (CETROTIDE)	17.1	± 8.0

Follicles >= 10 mm at End-of-stimulation visit

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	14.8	± 6.4
FE 999049 + GnRH Antagonist (CETROTIDE)	13.3	± 6.1

Follicles >= 12 mm at End-of-stimulation visit

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	12.2	± 5.3
FE 999049 + GnRH Antagonist (CETROTIDE)	10.9	± 5.1

Follicles >= 15 mm at End-of-stimulation visit

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	7.9	± 3.7
FE 999049 + GnRH Antagonist (CETROTIDE)	7.2	± 3.3

Follicles >= 17 mm at End-of-stimulation visit

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	4.8	± 2.1
FE 999049 + GnRH Antagonist (CETROTIDE)	4.6	± 2.0

Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved Secondary · On day of oocyte retrieval (up to 22 days after start of stimulation)

Grouped according to number of oocytes

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	13
FE 999049 + GnRH Antagonist (CETROTIDE)	26
FE 999049 + GnRH Agonist (GONAPEPTYL)	47
FE 999049 + GnRH Antagonist (CETROTIDE)	56
FE 999049 + GnRH Agonist (GONAPEPTYL)	84
FE 999049 + GnRH Antagonist (CETROTIDE)	82
FE 999049 + GnRH Agonist (GONAPEPTYL)	42
FE 999049 + GnRH Antagonist (CETROTIDE)	29

Number of Metaphase II Oocytes Secondary · On day of oocyte retrieval (up to 22 days after start of stimulation)

Only applicable for those inseminated using ICSI

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	9.2	± 4.8
FE 999049 + GnRH Antagonist (CETROTIDE)	7.9	± 4.7

Fertilization Rate Secondary · 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

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	53.8	± 24.1
FE 999049 + GnRH Antagonist (CETROTIDE)	54.4	± 26.8

Number of Embryos Secondary · 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

Total number of embryos

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	5.7	± 3.9
FE 999049 + GnRH Antagonist (CETROTIDE)	5.0	± 3.9

Number of good-quality embryos

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	4.0	± 3.2
FE 999049 + GnRH Antagonist (CETROTIDE)	3.9	± 3.3

Number of Blastocysts Secondary · 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)

Total Number of blastocysts

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	3.8	± 3.1
FE 999049 + GnRH Antagonist (CETROTIDE)	3.3	± 2.9

Number of good-quality blastocysts

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	2.3	± 2.3
FE 999049 + GnRH Antagonist (CETROTIDE)	2.1	± 2.2

Circulating Concentrations of Follicle-stimulating Hormone (FSH) Secondary · 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.

Stimulation Day 6

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	15.5	± 4.3
FE 999049 + GnRH Antagonist (CETROTIDE)	16.7	± 4.5

End-of-stimulation

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	16.2	± 4.4
FE 999049 + GnRH Antagonist (CETROTIDE)	15.8	± 4.0

Oocyte retrieval

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	9.4	± 2.8
FE 999049 + GnRH Antagonist (CETROTIDE)	9.8	± 2.9

Circulating Concentrations of Luteinizing Hormone (LH) Secondary · 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 LH were drawn

Stimulation Day 6

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	1.5	± 0.9
FE 999049 + GnRH Antagonist (CETROTIDE)	5.6	± 6.0

End-of-stimulation

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	1.8	± 0.9
FE 999049 + GnRH Antagonist (CETROTIDE)	1.8	± 1.5

Oocyte retrieval

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	0.2	± 0.2
FE 999049 + GnRH Antagonist (CETROTIDE)	2.0	± 2.1

Circulating Concentrations of Estradiol Secondary · 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 estradiol were drawn

Stimulation Day 6

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	1190.1	± 1101.2
FE 999049 + GnRH Antagonist (CETROTIDE)	2675.8	± 1544.3

End-of-stimulation

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	7542.7	± 4106.8
FE 999049 + GnRH Antagonist (CETROTIDE)	6487.7	± 3960.2

Oocyte retrieval

Group	Value	95% CI
FE 999049 + GnRH Agonist (GONAPEPTYL)	3485.1	± 2129.0
FE 999049 + GnRH Antagonist (CETROTIDE)	3163.5	± 1865.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were recorded from signing of the informed consent until end-of-trial (approximately 7 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FE 999049 + GnRH Agonist (GONAPEPTYL)

Serious: 4/202 (2%)

Deaths: 0/202

FE 999049 + GnRH Antagonist (CETROTIDE)

Serious: 6/204 (3%)

Deaths: 0/204

Serious adverse events (5 terms)

Reaction	System	FE 999049 + GnRH Agonist (…	FE 999049 + GnRH Antagonis…
Ovarian hyperstimulation syndrome	Reproductive system and breast disorders	—	—
Appendicitis	Infections and infestations	—	—
Bacterial abdominal infection	Infections and infestations	—	—
Hyperemesis gravidarum	Pregnancy, puerperium and perinatal conditions	—	—
Adnexal torsion	Reproductive system and breast disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	FE 999049 + GnRH Agonist (…	FE 999049 + GnRH Antagonis…
Headache	Nervous system disorders	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—
Pelvic pain	Reproductive system and breast disorders	—	—
Ovarian hyperstimulation syndrome	Reproductive system and breast disorders	—	—
Biochemical pregnancy	Pregnancy, puerperium and perinatal conditions	—	—

Most-reported serious reactions: Ovarian hyperstimulation syndrome, Appendicitis, Bacterial abdominal infection, Hyperemesis gravidarum, Adnexal torsion.

Data from ClinicalTrials.gov NCT03809429 adverse events section.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study).
Blockeel C, Griesinger G, Rago R, Larsson P, et al · · 2022 · cited 14× · PMID 36619578 · DOI 10.3389/fendo.2022.992677
Efficacy and safety of follitropin delta for ovarian stimulation in vitro fertilization/ intracytoplasmic sperm injection cycles: a systematic review with meta-analysis.
Palomba S, Caserta D, Levi-Setti PE, Busnelli A. · · 2024 · cited 8× · PMID 38486276 · DOI 10.1186/s13048-024-01372-w
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.
Lobo R, Soerdal T, Ekerhovd E, Cohlen B, et al · · 2024 · cited 7× · PMID 38723189 · DOI 10.1093/humrep/deae092
Follitropin Delta as a State-of-the-Art Incorporated Companion for Assisted Reproductive Procedures: A Two Year Observational Study.
Doroftei B, Ilie OD, Dabuleanu AM, Diaconu R, et al · · 2021 · cited 7× · PMID 33919919 · DOI 10.3390/medicina57040379
Live birth rates following individualized dosing algorithm of follitropin delta in a long GnRH agonist protocol.
Sánchez MF, Larsson P, Serrano MF, Bosch E, et al · · 2023 · cited 5× · PMID 37194068 · DOI 10.1186/s12958-023-01090-w
Efficacy and safety of follitropin delta versus follitropin alpha/beta in infertility treatment: A systematic review and meta-analysis.
Komiya S, Watanabe J, Terayama T, Kamijo K, et al · · 2024 · cited 4× · PMID 38528991 · DOI 10.1002/rmb2.12573

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03809429 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ferring Pharmaceuticals
Last refreshed: 13 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03809429.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03809429: BEYOND

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (5 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Infertility, Female

Other Ferring Pharmaceuticals trials

Verify against primary sources