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

NCT03809429 | Completed Phase 3 Results

• 2 other identifiers: 0003042017-002783-40
• Study Type: interventional
• Target: 437
• Locations: 7 countries
• Sites: 16

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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• Number of Oocytes Retrieved

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

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

Secondary Outcomes (26)

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

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

• 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)

• Number of Follicles

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

• 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)

• Number of Metaphase II Oocytes

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

Study Arms (2)

FE 999049 + GnRH agonist (GONAPEPTYL)

EXPERIMENTAL

Drug: FE 999049 + GnRH agonist (GONAPEPTYL)

FE 999049 + GnRH antagonist (CETROTIDE)

ACTIVE COMPARATOR

Drug: FE 999049 + GnRH antagonist (CETROTIDE)

Interventions

FE 999049 + GnRH agonist (GONAPEPTYL) DRUG

Pre-filled injection pen

FE 999049 + GnRH agonist (GONAPEPTYL)

FE 999049 + GnRH antagonist (CETROTIDE) DRUG

Powder and solvent for solution for injection

FE 999049 + GnRH antagonist (CETROTIDE)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women undergoing their first IVF/ICSI cycle and aged 18-40 years will be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (16)

Das Kinderwunsch Institut Schenk GmbH

Dobl, Austria

Location

Kepler University Hospital Linz

Linz, Austria

Location

Kinderwunschzentrum Goldenes Kreuz Privatklinik

Vienna, Austria

Location

Rigshospitalet

Copenhagen, Denmark

Location

Hillel Yafe Medical Center

Hadera, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Beilinson Hospital Rabin Medical Center

Petah Tikva, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

Dipartimento della Donna, del bambino e delle malattie urologiche

Bologna, Italy

Location

European Hospital

Roma, Italy

Location

St. Elisabeth Ziekenhuis

Tilburg, Netherlands

Location

Isala Fertility Center

Zwolle, Netherlands

Location

Oslo University Hospital

Oslo, Norway

Location

Sykehuset Telemark HF

Porsgrunn, Norway

Location

Medicus AS

Trondheim, Norway

Location

Gyn-A.R.T. AG

Zurich, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 38723189 DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

FE 999049; Gonadotropin-Releasing Hormone; cetrorelix

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Global Clinical Compliance
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

+1 833-548-1402

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 18, 2019
• Study Start: April 29, 2019
• Primary Completion: February 16, 2022
• Study Completion: February 16, 2022
• Last Updated: May 13, 2024
• Results First Posted: May 13, 2024

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); DK (1); IL (4); NL (2); IT (2); NO (3); CH (1)