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

Ferring

Status and phase

Completed

Phase 3

Conditions

Infertility, Female

Treatments

Drug: FE 999049 + GnRH antagonist (CETROTIDE)

Drug: FE 999049 + GnRH agonist (GONAPEPTYL)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03809429

2017-002783-40 (EudraCT Number)

000304

Details and patient eligibility

About

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.

Enrollment

437 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.