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Infertility, FemalePhase 3BEYONDNCT03809429

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

A Phase 3 study testing FE 999049 + GnRH agonist (GONAPEPTYL) and FE 999049 + GnRH antagonist (CETROTIDE) in people with Infertility, Female, run by Ferring Pharmaceuticals at 16 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Infertility, Female
What is being tested?
FE 999049 + GnRH agonist (GONAPEPTYL) and FE 999049 + GnRH antagonist (CETROTIDE)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
437 participants
Where
16 sitesin 7 countries
Study dates
29 Apr 2019to 16 Feb 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

16 sites in 7 countries.

16 sites in 7 countries

Israel4 sites

  • Hillel Yafe Medical Center

    Hadera

  • Shaare Zedek Medical Center

    Jerusalem

  • Beilinson Hospital Rabin Medical Center

    Petah Tikva

  • Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Austria3 sites

  • Das Kinderwunsch Institut Schenk GmbH

    Dobl

  • Kepler University Hospital Linz

    Linz

  • Kinderwunschzentrum Goldenes Kreuz Privatklinik

    Vienna

Other trials in Austria

Norway3 sites

  • Oslo University Hospital

    Oslo

  • Sykehuset Telemark HF

    Porsgrunn

  • Medicus AS

    Trondheim

Other trials in Norway

Italy2 sites

  • Dipartimento della Donna, del bambino e delle malattie urologiche

    Bologna

  • European Hospital

    Roma

Other trials in Italy

Netherlands2 sites

  • St. Elisabeth Ziekenhuis

    Tilburg

  • Isala Fertility Center

    Zwolle

Other trials in Netherlands

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

Switzerland1 site

  • Gyn-A.R.T. AG

    Zurich

Other trials in Switzerland

About this study

Official 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

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.

Being tested
FE 999049 + GnRH agonist (GONAPEPTYL), FE 999049 + GnRH antagonist (CETROTIDE)
Medical subject headings
Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FE 999049 + GnRH agonist (GONAPEPTYL)Drug

    Pre-filled injection pen

  • FE 999049 + GnRH antagonist (CETROTIDE)Drug

    Powder and solvent for solution for injection

Study groups in NCT03809429
Study groupRoleWhat they receive
FE 999049 + GnRH agonist (GONAPEPTYL)ExperimentalNot described
Receives: Drug: FE 999049 + GnRH agonist (GONAPEPTYL)
FE 999049 + GnRH antagonist (CETROTIDE)Active comparatorNot described
Receives: Drug: FE 999049 + GnRH antagonist (CETROTIDE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Oocytes Retrieved

    The number of oocytes retrieved was recorded at the oocyte retrieval visit.

    Measured: On day of oocyte retrieval (up to 22 days after start of stimulation)

Secondary outcomes (26)

  1. Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response

    For each participant, the reason for cycle cancellation was recorded

    Measured: At end-of-stimulation (up to 20 days)

  2. Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS)

    For each participant, the reason for blastocyst transfer cancellation was recorded.

    Measured: At end of transfer (up to 4 weeks)

  3. Number of Follicles

    The total number of follicles and the number of follicles per size category will be reported

    Measured: On stimulation day 6 and at end-of-stimulation (up to 20 days)

  4. Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved

    Grouped according to number of oocytes

    Measured: On day of oocyte retrieval (up to 22 days after start of stimulation)

  5. Number of Metaphase II Oocytes

    Only applicable for those inseminated using ICSI

    Measured: On day of oocyte retrieval (up to 22 days after start of stimulation)

  6. Fertilization Rate

    Measured by the number of pronuclei. Fertilized oocytes with 2 pronuclei were regarded as correctly fertilized

    Measured: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)

  7. Number of Embryos

    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

    Measured: On day 3 after oocyte retrieval (up to 25 days after start of stimulation)

  8. Number of Blastocysts

    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)

    Measured: On day 5 after oocyte retrieval (up to 27 days after start of stimulation)

  9. Circulating Concentrations of Follicle-stimulating Hormone (FSH)

    Blood samples for analysis of circulating concentrations of FSH were drawn.

    Measured: 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)

  10. Circulating Concentrations of Luteinizing Hormone (LH)

    Blood samples for analysis of circulating concentrations of LH were drawn

    Measured: 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)

  11. Circulating Concentrations of Estradiol

    Blood samples for analysis of circulating concentrations of estradiol were drawn

    Measured: 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)

  12. Circulating Concentrations of Progesterone

    Blood samples for analysis of circulating concentrations of progesterone were drawn

    Measured: 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)

  13. Circulating Concentrations of Inhibin B

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

    Measured: 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)

  14. Total Gonadotropin Dose

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

    Measured: Up to 20 days

  15. Number of Stimulation Days

    Calculated by start dates and end dates

    Measured: Up to 20 days

  16. Positive Beta Human Chorionic Gonadotropin (βhCG) Rate

    Defined as positive serum βhCG test

    Measured: 13-15 days after transfer (up to approximately 1.5 months after start of stimulation)

  17. Implantation Rate

    Defined as the number of gestational sacs after transfer divided by number of blastocysts transferred

    Measured: 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)

  18. Clinical Pregnancy Rate

    Defined as at least one gestational sac

    Measured: 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)

  19. Vital Pregnancy Rate

    Defined as at least one intrauterine gestational sac with fetal heart beat

    Measured: 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)

  20. Ongoing Pregnancy Rate

    At least one intrauterine viable fetus

    Measured: 10-11 weeks after transfer (up to approximately 4 months after start of stimulation)

  21. Ongoing Implantation Rate

    Defined as number of intrauterine viable fetuses divided by the number of blastocysts transferred

    Measured: 10-11 weeks after transfer (up to approximately 4 months after start of stimulation)

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

    Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.

    Measured: Up to 9 days after triggering of final follicular maturation

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

    Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.

    Measured: >9 days after triggering of final follicular maturation

  24. Frequency of Adverse Events

    Any untoward medical occurrence

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

  25. Intensity of Adverse Events

    Categorized as mild, moderate or severe

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

  26. Technical Malfunctions of the Pre-filled Injection Pen

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

    Measured: Up to 20 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2019
  2. Study start29 Apr 2019
  3. Primary completion16 Feb 2022
  4. Study completion16 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
437 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03809429
Sponsor's protocol ID
000304
Other IDs
2017-002783-40, 2017
Acronym
BEYOND
Status last verified
Sep 2022
First submitted
7 Jan 2019
Last updated
13 May 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lobo R, Soerdal T, Ekerhovd E, Cohlen B, Porcu E, Schenk M, Shufaro Y, Smeenk J, Suerdieck MB, Pinton P, Pinborg A; BEYOND Investigators. BEYOND: a randomized controlled trial comparing efficacy and safety of individualized follitropin delta dosing in a GnRH agonist versus antagonist protocol during the first ovarian stimulation cycle. Hum Reprod. 2024 May 9;39(7):1481-94. doi: 10.1093/humrep/deae092. Online ahead of print.

    PubMed 38723189

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FE 999049 + GnRH agonist (GONAPEPTYL) and FE 999049 + GnRH antagonist (CETROTIDE) in people with Infertility, Female, run by Ferring Pharmaceuticals at 16 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Israel, Austria, Norway, Italy, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Oocytes Retrieved (time frame: On day of oocyte retrieval (up to 22 days after start of stimulation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03809429, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.

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