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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    415
  • sponsor
    Ferring Pharmaceuticals
Updated on 21 July 2021
body mass index
gonadotropin
follicle stimulating hormone
endometriosis
ovarian stimulation
in vitro fertilization
intracytoplasmic sperm injection
gonadotropin releasing hormone antagonist
follitropin delta

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.

Details
Condition Female infertility
Treatment FE 999049 + GnRH agonist (GONAPEPTYL), FE 999049 + GnRH antagonist (CETROTIDE)
Clinical Study IdentifierNCT03809429
SponsorFerring Pharmaceuticals
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

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
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