Phase 3
N=435
Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)
Infertility, Female
Bottom Line
View on ClinicalTrials.gov: NCT03809429 ↗Enrolled (actual)
435
Serious AEs
2.5%
Results posted
May 2024
Primary outcome: Primary: Number of Oocytes Retrieved — 11.1; 9.6 Oocytes — p=0.0185
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FE 999049 + GnRH agonist (GONAPEPTYL) (Drug); FE 999049 + GnRH antagonist (CETROTIDE) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Oocytes Retrieved |
11.1; 9.6 | 0.0185 sig |
| SECONDARY Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response |
2; 3; 1; 3; 1; 1 | — |
| SECONDARY Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS) |
27; 30; 5; 8; 1; 1 | — |
| SECONDARY Number of Follicles |
15.2; 14.9; 4.6; 7.1; 1.6; 3.8 | 0.0281 sig |
| SECONDARY Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved |
13; 26; 47; 56; 84; 82 | — |
| SECONDARY Number of Metaphase II Oocytes |
9.2; 7.9 | 0.0962 |
| SECONDARY Fertilization Rate |
53.8; 54.4 | — |
| SECONDARY Number of Embryos |
5.7; 5.0; 4.0; 3.9 | 0.1894 |
| SECONDARY Number of Blastocysts |
3.8; 3.3; 2.3; 2.1 | 0.2025 |
| SECONDARY Circulating Concentrations of Follicle-stimulating Hormone (FSH) |
15.5; 16.7; 16.2; 15.8; 9.4; 9.8 | — |
| SECONDARY Circulating Concentrations of Luteinizing Hormone (LH) |
1.5; 5.6; 1.8; 1.8; 0.2; 2.0 | — |
| SECONDARY Circulating Concentrations of Estradiol |
1190.1; 2675.8; 7542.7; 6487.7; 3485.1; 3163.5 | — |
| SECONDARY Circulating Concentrations of Progesterone |
1.8; 2.6; 3.1; 3.5; 25.9; 26.0 | — |
| SECONDARY Circulating Concentrations of Inhibin B |
690.4; 808.2; 1032.6; 938.1; 416.6; 389.0 | — |
| SECONDARY Total Gonadotropin Dose |
112.2; 96.5 | <0.0001 sig |
| SECONDARY Number of Stimulation Days |
10.4; 8.8 | <0.0001 sig |
| SECONDARY Positive Beta Human Chorionic Gonadotropin (βhCG) Rate |
91; 79; 111; 125 | 0.1579 |
| SECONDARY Implantation Rate |
82; 68 | — |
| SECONDARY Clinical Pregnancy Rate |
81; 68; 121; 136 | 0.1134 |
| SECONDARY Vital Pregnancy Rate |
77; 62; 125; 142 | 0.0642 |
| SECONDARY Ongoing Pregnancy Rate |
73; 60; 129; 144 | 0.1002 |
| SECONDARY Ongoing Implantation Rate |
74; 60 | — |
| SECONDARY Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) |
8; 5 | — |
| SECONDARY Proportion of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade) |
4; 6 | — |
| SECONDARY Frequency of Adverse Events |
112; 109 | — |
| SECONDARY Intensity of Adverse Events |
42.6; 41.7; 18.8; 16.7; 4.0; 3.4 | — |
| SECONDARY Technical Malfunctions of the Pre-filled Injection Pen |
2; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03809429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.