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

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ClinicalTrials.gov Identifier: NCT03809429
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 7, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE April 29, 2019
Estimated Primary Completion Date November 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
Number of oocytes retrieved [ Time Frame: On day of oocyte retrieval (up to 22 days after start of stimulation) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03809429 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • 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 subject, the reason for cycle cancellation will be 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 subject, the reason for blastocyst transfer cancellation will be 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 will be 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) will be reported. Embryo quality is determined by combined assesment 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) will be 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), 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) ]
  • Total gonadotropin dose [ Time Frame: Up to 20 days ]
    Calculated by start dates, end dates and daily dose of investigational medicinal product
  • Number of stimulation days [ Time Frame: Up to 20 days ]
    Calculated by start dates and end dates
  • Positive beta human chorionic gonadotropin (βhCG) rate [ Time Frame: 13-15 days after transfer (up to approximately 1.5 months after start of stimulation) ]
    Defined as positive serum βhCG test
  • Implantation rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 10-11 weeks after transfer (up to approximately 4 months after start of stimulation) ]
    At least one intrauterine viable fetus
  • Ongoing implantation rate [ Time Frame: 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) [ Time Frame: Up to 9 days after triggering of final follicular maturation ]
    Measured as mild, moderate or severe
  • Proportion of subjects with late OHSS (including OHSS of moderate/severe grade) [ Time Frame: >9 days after triggering of final follicular maturation ]
    Measured as mild, moderate or severe
  • Frequency of adverse events [ Time Frame: From time of signing informed consent until the end-of-trial (approximately 7 months) ]
    Any untoward medical occurrence
  • Intensity of adverse events [ Time Frame: 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 [ Time Frame: Up to 20 days ]
    Incidences of technical malfunctions of the pre-filled injection pen will be recorded
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility, Female
Intervention  ICMJE
  • Drug: FE 999049 + GnRH agonist (GONAPEPTYL)
    FE 999049 + GnRH agonist (GONAPEPTYL)
  • Drug: FE 999049 + GnRH antagonist (CETROTIDE)
    FE 999049 + GnRH antagonist (CETROTIDE)
Study Arms  ICMJE
  • Experimental: FE 999049 + GnRH agonist (GONAPEPTYL)
    Intervention: Drug: FE 999049 + GnRH agonist (GONAPEPTYL)
  • Experimental: FE 999049 + GnRH antagonist (CETROTIDE)
    Intervention: Drug: FE 999049 + GnRH antagonist (CETROTIDE)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date November 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Women undergoing their first IVF/ICSI cycle and aged 18-40 years will be included.
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Global Clinical Compliance +1 833-548-1402 (US/Canada) DK0-Disclosure@ferring.com
Contact: Global Clinical Compliance +1 862-286-5200 (outside US) DK0-Disclosure@ferring.com
Listed Location Countries  ICMJE Austria,   Denmark,   Israel,   Italy,   Netherlands,   Norway,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809429
Other Study ID Numbers  ICMJE 000304
2017-002783-40 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Compliance Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP