NCT03228680 is a Phase 3 clinical trial of Follitropin delta in Infertility, sponsored by Ferring Pharmaceuticals.

Who is sponsoring NCT03228680?

NCT03228680 is sponsored by Ferring Pharmaceuticals.

What drugs are being tested in NCT03228680?

Interventions in NCT03228680: Follitropin delta, Follitropin beta.

What condition does NCT03228680 study?

NCT03228680 studies Infertility.

Is NCT03228680 still recruiting?

NCT03228680 is currently completed. Last updated 24 August 2023.

Are results published for NCT03228680?

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

Last reviewed 2023-08-24 · How we verify

NCT03228680

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

Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women

Completed Phase 3 Results posted Last updated 24 August 2023

What this trial tests

Phase 3 trial testing Follitropin delta in Infertility in 373 participants. Completed in 8 July 2019.

Timeline

29 July 2017

Primary endpoint
10 June 2019

8 July 2019

Quick facts

Lead sponsor	Ferring Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	373
Start date	29 July 2017
Primary completion	10 June 2019
Estimated completion	8 July 2019
Sites	17 locations across Japan

Drugs / interventions tested

Follitropin delta — full drug profile →
Follitropin beta — full drug profile →

Conditions studied

Infertility — all drugs for Infertility →

Sponsor

Ferring Pharmaceuticals — full company profile →

Who can join

Adults 20 to 40, female only, with Infertility. 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 · 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.

Group	Value	95% CI
FE 999049 (Follitropin Delta)	9.3	± 5.4
FOLLISTIM (Follitropin Beta)	10.5	± 6.1

Clinical Pregnancy Rate Secondary · 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.

Group	Value	95% CI
FE 999049 (Follitropin Delta)	25.3
FOLLISTIM (Follitropin Beta)	23.7

Positive Beta Unit of Human Chorionic Gonadotropin (Beta-hCG) Rate Secondary · 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.

Group	Value	95% CI
FE 999049 (Follitropin Delta)	29.4
FOLLISTIM (Follitropin Beta)	29.4

Vital Pregnancy Rate Secondary · 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.

Group	Value	95% CI
FE 999049 (Follitropin Delta)	23.5
FOLLISTIM (Follitropin Beta)	21.5

Implantation Rate Secondary · 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.

Group	Value	95% CI
FE 999049 (Follitropin Delta)	31.9
FOLLISTIM (Follitropin Beta)	29.8

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

Cycle cancelled due to poor ovarian response

Group	Value	95% CI
FE 999049 (Follitropin Delta)	1.2
FOLLISTIM (Follitropin Beta)	0.6

Cycle cancelled due to excessive ovarian response

Group	Value	95% CI
FE 999049 (Follitropin Delta)	0
FOLLISTIM (Follitropin Beta)	1.1

Proportion of Participants With Blastocyst Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk Secondary · End-of-stimulation (up to 20 stimulation days)

Group	Value	95% CI
FE 999049 (Follitropin Delta)	7.6
FOLLISTIM (Follitropin Beta)	11.3

Proportion of Participants With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved Secondary · 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.

Low response (<4 oocytes)

Group	Value	95% CI
FE 999049 (Follitropin Delta)	8.3
FOLLISTIM (Follitropin Beta)	5.2

Moderate response (4-7 oocytes)

Group	Value	95% CI
FE 999049 (Follitropin Delta)	36.1
FOLLISTIM (Follitropin Beta)	26.6

Targeted response (8-14 oocytes)

Group	Value	95% CI
FE 999049 (Follitropin Delta)	40.8
FOLLISTIM (Follitropin Beta)	42.8

Hyperresponse (15-19 oocytes)

Group	Value	95% CI
FE 999049 (Follitropin Delta)	10.1
FOLLISTIM (Follitropin Beta)	14.5

Severe hyperresponse (≥ 20 oocytes)

Group	Value	95% CI
FE 999049 (Follitropin Delta)	4.7
FOLLISTIM (Follitropin Beta)	11.0

Proportion of Participants With Extreme Ovarian Responses (Defined as <4, ≥15 or ≥20 Oocytes Retrieved) in Risk Population Secondary · On the day of oocyte retrieval (up to 22 days after start of stimulation)

AMH < 15 pmol/L (<4 oocytes retrieved)

Group	Value	95% CI
FE 999049 (Follitropin Delta)	11.6
FOLLISTIM (Follitropin Beta)	12.3

AMH >= 15 pmol/L (>=15 oocytes retrieved)

Group	Value	95% CI
FE 999049 (Follitropin Delta)	22.0
FOLLISTIM (Follitropin Beta)	42.0

AMH >= 15 pmol/L (>=20 oocytes retrieved)

Group	Value	95% CI
FE 999049 (Follitropin Delta)	8.0
FOLLISTIM (Follitropin Beta)	19.0

Proportion of Participants With Preventive Interventions for Early Ovarian Hyperstimulation Syndrome (OHSS) Secondary · ≤9 days after triggering of final follicular maturation

Cycle cancellation

Group	Value	95% CI
FE 999049 (Follitropin Delta)	0
FOLLISTIM (Follitropin Beta)	1.1

Triggering with GnRH agonist

Group	Value	95% CI
FE 999049 (Follitropin Delta)	1.2
FOLLISTIM (Follitropin Beta)	1.1

Administration of dopamine agonist

Group	Value	95% CI
FE 999049 (Follitropin Delta)	0.6
FOLLISTIM (Follitropin Beta)	1.7

Proportions of Participants With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS Secondary · Up to 9 days after triggering of final follicular maturation

Defined as proportion of participants with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented.

Early OHSS (any grade)

Group	Value	95% CI
FE 999049 (Follitropin Delta)	10.0
FOLLISTIM (Follitropin Beta)	18.6

Early OHSS (moderate/severe)

Group	Value	95% CI
FE 999049 (Follitropin Delta)	6.5
FOLLISTIM (Follitropin Beta)	13.0

Early OHSS (any grade) and/or preventive

Group	Value	95% CI
FE 999049 (Follitropin Delta)	10.6
FOLLISTIM (Follitropin Beta)	20.9

Early OHSS (moderate/severe) and/or preventive

Group	Value	95% CI
FE 999049 (Follitropin Delta)	7.6
FOLLISTIM (Follitropin Beta)	16.4

Proportions of Participants With Late OHSS (Including OHSS of Moderate/Severe Grade) Secondary · >9 days after triggering of final follicular maturation

Defined as proportions of participants with late OHSS (including OHSS of moderate/severe grade). Late OHSS was defined as OHSS with onset \>9 days after triggering of final follicular maturation. The proportion of participants with late OHSS, and late OHSS of moderate or severe grade are presented. All OHSS cases were graded as mild, moderate, or severe.

Late OHSS (any grade)

Group	Value	95% CI
FE 999049 (Follitropin Delta)	1.2
FOLLISTIM (Follitropin Beta)	1.1

Late OHSS (moderate/severe)

Group	Value	95% CI
FE 999049 (Follitropin Delta)	0.6
FOLLISTIM (Follitropin Beta)	1.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FE 999049 (Follitropin Delta)

Serious: 0/170 (0%)

Deaths: 0/170

FOLLISTIM (Follitropin Beta)

Serious: 2/177 (1%)

Deaths: 0/177

Serious adverse events (1 terms)

Reaction	System	FE 999049 (Follitropin Del…	FOLLISTIM (Follitropin Beta)
Ovarian hyperstimulation syndrome	Reproductive system and breast disorders	—	—

Other adverse events (12 terms — click to expand)

Reaction	System	FE 999049 (Follitropin Del…	FOLLISTIM (Follitropin Beta)
Ovarian hyperstimulation syndrome	Reproductive system and breast disorders	—	—
Injection site erythema	General disorders	—	—
Biochemical pregnancy	Pregnancy, puerperium and perinatal conditions	—	—
Ovarian cyst	Reproductive system and breast disorders	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—
Constipation	Gastrointestinal disorders	—	—
Injection site pruritus	General disorders	—	—
Ovarian enlargement	Reproductive system and breast disorders	—	—
Headache	Nervous system disorders	—	—
Abortion spontenous	Pregnancy, puerperium and perinatal conditions	—	—
Haemorrhage in pregnancy	Pregnancy, puerperium and perinatal conditions	—	—
Pelvic fluid collection	Reproductive system and breast disorders	—	—

Most-reported serious reactions: Ovarian hyperstimulation syndrome.

Data from ClinicalTrials.gov NCT03228680 adverse events section.

Sponsor's own description

To demonstrate non-inferiority of FE 999049 compared to FOLLISTIM with respect to number of oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation.

Publications & conference data

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

Individualised gonadotropin dose selection using markers of ovarian reserve for women undergoing in vitro fertilisation plus intracytoplasmic sperm injection (IVF/ICSI).
Ngwenya O, Lensen SF, Vail A, Mol BWJ, et al · · 2024 · cited 12× · PMID 38174816 · DOI 10.1002/14651858.cd012693.pub3
Incidence and severity of ovarian hyperstimulation syndrome (OHSS) in high responders after gonadotropin-releasing hormone (GnRH) agonist trigger in "freeze-all" approach.
Fernández-Sánchez M, Fatemi H, García-Velasco JA, Heiser PW, et al · · 2023 · cited 10× · PMID 37156263 · DOI 10.1080/09513590.2023.2205952
A Narrative Review Discussing the Efficiency of Personalized Dosing Algorithm of Follitropin Delta for Ovarian Stimulation and the Reproductive and Clinical Outcomes.
Doroftei B, Ilie OD, Anton N, Marcu OA, et al · · 2023 · cited 9× · PMID 36672987 · DOI 10.3390/diagnostics13020177
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
Comparison of ovarian response to follitropin delta in Japanese and White IVF/ICSI patients.
Ishihara O, Nelson SM, Arce JC. · · 2022 · cited 5× · PMID 34799275 · DOI 10.1016/j.rbmo.2021.09.014
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
The pregnancy outcomes among women receiving individualized algorithm dosing with follitropin delta: a systematic review of randomized controlled trials.
Doroftei B, Ilie OD, Dabuleanu AM, Armeanu T, et al · · 2024 · cited 2× · PMID 38809330 · DOI 10.1007/s10815-024-03146-1
Cost-Effectiveness of Follitropin Delta Compared with Follitropins Alfa and Beta in Controlled Ovarian Stimulation for Assisted Reproductive Technologies (ART) in France.
Hamamah S, Carette J, Leleu H, Markert M. · · 2026 · PMID 41811581 · DOI 10.1007/s41669-026-00641-2

Verify or expand the search:

Other trials of Follitropin delta

Trials testing the same drug.

NCT06511791 — An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta at Different Time · Phase 1 · terminated
NCT06466486 — An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta During Controlled · Phase 1 · terminated
NCT05873725 — Retrospective Study of High Dose Follitropin Delta in a Mixed Protocol With Human Chorionic Gonadotropin · completed
NCT05103228 — Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders · NA · completed
NCT03830723 — Personalized Insemination Treatment Study · Phase 2 · completed

Other recruiting trials for Infertility

Currently open trials in the same condition.

NCT07074015 — IntelliWell: An AI-Assisted Imaging Platform for Detection and Location of Ultra-Rare Testicular Sperm in Surgical Speci · NA · recruiting
NCT07358468 — Impact Of FET Preparation Protocol On Endometrial Peristalsis: A Prospective Cohort Study · recruiting
NCT07340827 — A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH · Phase 3 · recruiting
NCT07369362 — To Investigate if the Harvester® Improves Sperm Motility and Blastocyst Utilization (the Percent of Fertilized Eggs That · NA · active not recruiting
NCT07153367 — Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauter · Phase 2 · recruiting

Other Ferring Pharmaceuticals trials

Trials by the same sponsor.

NCT07152730 — A Study to Measure Pharmacokinetic (PK) Concentrations of Gonadotropin-Releasing Hormone Delivered by the OmniPod Pump · Phase 1 · withdrawn
NCT07029451 — To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patt · recruiting
NCT06668493 — Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis · Phase 1, PHASE2 · recruiting
NCT06545955 — A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in · Phase 3 · recruiting
NCT06510374 — Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Can · Phase 3 · recruiting

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 NCT03228680 (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: 24 August 2023

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/NCT03228680.

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