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

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Cetrorelix; Deslorelin; Follicle Stimulating Hormone; Prolactin Release-Inhibiting Factors; Triptorelin Pamoate

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.