Clinical trial NCT03809429: Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility, Female
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-01-18
Enrollment: 437
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Oocytes Retrieved
timeFrame: On day of oocyte retrieval (up to 22 days after start of stimulation)
Secondary outcomes:
measure: Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response
timeFrame: At end-of-stimulation (up to 20 days)
measure: Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS)
timeFrame: At end of transfer (up to 4 weeks)
measure: Number of Follicles
timeFrame: On stimulation day 6 and at end-of-stimulation (up to 20 days)
measure: Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
timeFrame: On day of oocyte retrieval (up to 22 days after start of stimulation)
measure: Number of Metaphase II Oocytes
timeFrame: On day of oocyte retrieval (up to 22 days after start of stimulation)
measure: Fertilization Rate
timeFrame: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
measure: Number of Embryos
timeFrame: On day 3 after oocyte retrieval (up to 25 days after start of stimulation)
measure: Number of Blastocysts
timeFrame: On day 5 after oocyte retrieval (up to 27 days after start of stimulation)
measure: Circulating Concentrations of Follicle-stimulating Hormone (FSH)
timeFrame: 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)
measure: Circulating Concentrations of Luteinizing Hormone (LH)
timeFrame: 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)
measure: Circulating Concentrations of Estradiol
timeFrame: 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)
measure: Circulating Concentrations of Progesterone
timeFrame: 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)
measure: Circulating Concentrations of Inhibin B
timeFrame: 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)
measure: Total Gonadotropin Dose
timeFrame: Up to 20 days
measure: Number of Stimulation Days
timeFrame: Up to 20 days
measure: Positive Beta Human Chorionic Gonadotropin (βhCG) Rate
timeFrame: 13-15 days after transfer (up to approximately 1.5 months after start of stimulation)
measure: Implantation Rate
timeFrame: 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)
measure: Clinical Pregnancy Rate
timeFrame: 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)
measure: Vital Pregnancy Rate
timeFrame: 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)
measure: Ongoing Pregnancy Rate
timeFrame: 10-11 weeks after transfer (up to approximately 4 months after start of stimulation)
measure: Ongoing Implantation Rate
timeFrame: 10-11 weeks after transfer (up to approximately 4 months after start of stimulation)
measure: Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade)
timeFrame: Up to 9 days after triggering of final follicular maturation
measure: Proportion of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade)
timeFrame: >9 days after triggering of final follicular maturation
measure: Frequency of Adverse Events
timeFrame: From time of signing informed consent until the end-of-trial (approximately 7 months)
measure: Intensity of Adverse Events
timeFrame: From time of signing informed consent until the end-of-trial (approximately 7 months)
measure: Technical Malfunctions of the Pre-filled Injection Pen
timeFrame: Up to 20 days
Other outcomes:
Locations:
city: Dobl
country: Austria
facility: Das Kinderwunsch Institut Schenk GmbH
city: Linz
country: Austria
facility: Kepler University Hospital Linz
city: Vienna
country: Austria
facility: Kinderwunschzentrum Goldenes Kreuz Privatklinik
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Hadera
country: Israel
facility: Hillel Yafe Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Petah tikva
country: Israel
facility: Beilinson Hospital Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Bologna
country: Italy
facility: Dipartimento della Donna, del bambino e delle malattie urologiche
city: Roma
country: Italy
facility: European Hospital
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Fertility Center
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Porsgrunn
country: Norway
facility: Sykehuset Telemark HF
city: Trondheim
country: Norway
facility: Medicus AS
city: Zürich
country: Switzerland
facility: Gyn-A.R.T. AG
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: