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Completed

NCT Number: NCT03809429

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

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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Das Kinderwunsch Institut Schenk GmbH, Dobl, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FE 999049 + GnRH agonist (GONAPEPTYL)

Drug

Pre-filled injection pen

FE 999049 + GnRH antagonist (CETROTIDE)

Drug

Powder and solvent for solution for injection

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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.

  10. 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

  11. Circulating Concentrations of Estradiol

    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 estradiol were drawn

  12. Circulating Concentrations of Progesterone

    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 progesterone were drawn

  13. Circulating Concentrations of 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)

    Blood samples for analysis of circulating concentrations of Inhibin B were drawn

  14. Total Gonadotropin Dose

    Time frame: Up to 20 days

    Calculated by start dates, end dates and daily dose of investigational medicinal product

  15. Number of Stimulation Days

    Time frame: Up to 20 days

    Calculated by start dates and end dates

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade)

    Time frame: 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.

  23. Proportion of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade)

    Time frame: >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.

  24. Frequency of Adverse Events

    Time frame: From time of signing informed consent until the end-of-trial (approximately 7 months)

    Any untoward medical occurrence

  25. 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

  26. Technical Malfunctions of the Pre-filled Injection Pen

    Time frame: Up to 20 days

    Incidences of technical malfunctions of the pre-filled injection pen were recorded

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: BEYOND

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2019
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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