Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)
- Conditions
- Infertility, Female
- Interventions
- Registration Number
- NCT03809429
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 437
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FE 999049 + GnRH antagonist (CETROTIDE) FE 999049 + GnRH antagonist (CETROTIDE) - FE 999049 + GnRH agonist (GONAPEPTYL) FE 999049 + GnRH agonist (GONAPEPTYL) -
- Primary Outcome Measures
Name Time Method Number of Oocytes Retrieved 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.
- Secondary Outcome Measures
Name Time Method Number of Follicles 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
Circulating Concentrations of Progesterone 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 progesterone were drawn
Circulating Concentrations of Estradiol 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
Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response 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) At end of transfer (up to 4 weeks) For each participant, the reason for blastocyst transfer cancellation was recorded.
Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved On day of oocyte retrieval (up to 22 days after start of stimulation) Grouped according to number of oocytes
Number of Metaphase II Oocytes On day of oocyte retrieval (up to 22 days after start of stimulation) Only applicable for those inseminated using ICSI
Fertilization Rate 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
Circulating Concentrations of Follicle-stimulating Hormone (FSH) 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.
Number of Embryos 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 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 Luteinizing Hormone (LH) 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
Circulating Concentrations of Inhibin B 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 Inhibin B were drawn
Total Gonadotropin Dose Up to 20 days Calculated by start dates, end dates and daily dose of investigational medicinal product
Number of Stimulation Days Up to 20 days Calculated by start dates and end dates
Positive Beta Human Chorionic Gonadotropin (βhCG) Rate 13-15 days after transfer (up to approximately 1.5 months after start of stimulation) Defined as positive serum βhCG test
Implantation Rate 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation) Defined as the number of gestational sacs after transfer divided by number of blastocysts transferred
Clinical Pregnancy Rate 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation) Defined as at least one gestational sac
Vital Pregnancy Rate 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation) Defined as at least one intrauterine gestational sac with fetal heart beat
Ongoing Pregnancy Rate 10-11 weeks after transfer (up to approximately 4 months after start of stimulation) At least one intrauterine viable fetus
Ongoing Implantation Rate 10-11 weeks after transfer (up to approximately 4 months after start of stimulation) Defined as number of intrauterine viable fetuses divided by the number of blastocysts transferred
Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) Up to 9 days after triggering of final follicular maturation Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.
Proportion of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade) >9 days after triggering of final follicular maturation Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.
Frequency of Adverse Events From time of signing informed consent until the end-of-trial (approximately 7 months) Any untoward medical occurrence
Intensity of Adverse Events From time of signing informed consent until the end-of-trial (approximately 7 months) Categorized as mild, moderate or severe
Technical Malfunctions of the Pre-filled Injection Pen Up to 20 days Incidences of technical malfunctions of the pre-filled injection pen were recorded
Trial Locations
- Locations (16)
Das Kinderwunsch Institut Schenk GmbH
🇦🇹Dobl, Austria
Oslo University Hospital
🇳🇴Oslo, Norway
Sykehuset Telemark HF
🇳🇴Porsgrunn, Norway
Gyn-A.R.T. AG
🇨🇭Zürich, Switzerland
Isala Fertility Center
🇳🇱Zwolle, Netherlands
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Rigshospitalet
🇩🇰Copenhagen, Denmark
Kepler University Hospital Linz
🇦🇹Linz, Austria
Kinderwunschzentrum Goldenes Kreuz Privatklinik
🇦🇹Vienna, Austria
Hillel Yafe Medical Center
🇮🇱Hadera, Israel
Dipartimento della Donna, del bambino e delle malattie urologiche
🇮🇹Bologna, Italy
Beilinson Hospital Rabin Medical Center
🇮🇱Petah tikva, Israel
St. Elisabeth Ziekenhuis
🇳🇱Tilburg, Netherlands
Sourasky Medical Center
🇮🇱Tel Aviv, Israel
European Hospital
🇮🇹Roma, Italy
Medicus AS
🇳🇴Trondheim, Norway