Status:
COMPLETED
Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Infertility, Female
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
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 inje...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2022
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT03809429
Start Date
April 29 2019
End Date
February 16 2022
Last Update
May 13 2024
Active Locations (16)
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1
Das Kinderwunsch Institut Schenk GmbH
Dobl, Austria
2
Kepler University Hospital Linz
Linz, Austria
3
Kinderwunschzentrum Goldenes Kreuz Privatklinik
Vienna, Austria
4
Rigshospitalet
Copenhagen, Denmark