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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2022
• Main ID: NCT03809429
• Date of registration: 07/01/2019
• Prospective Registration: Yes
• Primary sponsor: Ferring Pharmaceuticals
• Public title: Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND) BEYOND
• Scientific title: A Randomised, Controlled, Open Label, Parallel Group, Multicentre Trial Comparing the Efficacy and Safety of Individualised FE 999049 (Follitropin Delta) Dosing, Using a Long GnRH Agonist Protocol and a GnRH Antagonist Protocol in Women Undergoing Controlled Ovarian Stimulation
• Date of first enrolment: April 29, 2019
• Target sample size: 437
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03809429
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Austria, Denmark, Israel, Italy, Netherlands, Norway, Switzerland

Contacts

• Name: Global Clinical Compliance
• Affiliation: Ferring Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Infertility, Female

Intervention(s)

Drug: FE 999049 + GnRH antagonist (CETROTIDE)

Drug: FE 999049 + GnRH agonist (GONAPEPTYL)

Primary Outcome(s)

Number of oocytes retrieved [Time Frame: On day of oocyte retrieval (up to 22 days after start of stimulation)]

Secondary Outcome(s)

Number of blastocysts [Time Frame: On day 5 after oocyte retrieval (up to 27 days after start of stimulation)]

Number of embryos [Time Frame: On day 3 after oocyte retrieval (up to 25 days after start of stimulation)]

Number of stimulation days [Time Frame: Up to 20 days]

Technical malfunctions of the pre-filled injection pen [Time Frame: Up to 20 days]

Frequency of adverse events [Time Frame: From time of signing informed consent until the end-of-trial (approximately 7 months)]

Ongoing pregnancy rate [Time Frame: 10-11 weeks after transfer (up to approximately 4 months after start of stimulation)]

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)]

Number of follicles [Time Frame: On stimulation day 6 and at end-of-stimulation (up to 20 days)]

Ongoing implantation rate [Time Frame: 10-11 weeks after transfer (up to approximately 4 months after start of stimulation)]

Circulating concentrations of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone and inhibin B [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)]

Positive beta human chorionic gonadotropin (ßhCG) rate [Time Frame: 13-15 days after transfer (up to approximately 1.5 months after start of stimulation)]

Intensity of adverse events [Time Frame: From time of signing informed consent until the end-of-trial (approximately 7 months)]

Vital pregnancy rate [Time Frame: 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)]

Fertilization rate [Time Frame: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)]

Number of metaphase II oocytes [Time Frame: On day of oocyte retrieval (up to 22 days after start of stimulation)]

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)]

Total gonadotropin dose [Time Frame: Up to 20 days]

Clinical pregnancy rate [Time Frame: 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)]

Implantation rate [Time Frame: 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)]

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)]

Proportion of subjects with early OHSS (including OHSS of moderate/severe grade) [Time Frame: Up to 9 days after triggering of final follicular maturation]

Proportion of subjects with late OHSS (including OHSS of moderate/severe grade) [Time Frame: >9 days after triggering of final follicular maturation]

Secondary ID(s)

000304

2017-002783-40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors