DRUG
FE 999049 + GnRH agonist (GONAPEPTYL)
Pre-filled injection pen
Status
Completed
Phase
Phase 3
Enrollment
437
Locations
16
Results
Posted
Publications
1
Study summary
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
DRUG
Pre-filled injection pen
DRUG
Powder and solvent for solution for injection
Timeline
First posted
Jan 18, 2019
Study start
Apr 29, 2019
Primary completion
Feb 16, 2022
Study completion
Feb 16, 2022
Results posted
May 13, 2024
Registry updated
May 13, 2024
Outcomes
Number of Oocytes Retrieved
Time frame · 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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Blood samples for analysis of circulating concentrations of LH were drawn
Eligibility
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.
Study locations
Austria · Denmark · Israel · Italy · Netherlands · Norway · Switzerland. Showing up to 24 locations stored in the fast local snapshot.
Das Kinderwunsch Institut Schenk GmbH
Dobl, Austria
Kepler University Hospital Linz
Linz, Austria
Kinderwunschzentrum Goldenes Kreuz Privatklinik
Vienna, Austria
Rigshospitalet
Copenhagen, Denmark
Hillel Yafe Medical Center
Hadera, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Beilinson Hospital Rabin Medical Center
Petah Tikva, Israel
Sourasky Medical Center
Tel Aviv, Israel
Dipartimento della Donna, del bambino e delle malattie urologiche
Bologna, Italy
European Hospital
Roma, Italy
St. Elisabeth Ziekenhuis
Tilburg, Netherlands
Isala Fertility Center
Zwolle, Netherlands
Oslo University Hospital
Oslo, Norway
Sykehuset Telemark HF
Porsgrunn, Norway
Medicus AS
Trondheim, Norway
Gyn-A.R.T. AG
Zurich, Switzerland
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