A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Ovarian Response of a Starting Dose of 15 μg Follitropin Delta (REKOVELLE) to a Starting Dose of 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

Hormone preparations like REKOVELLE and GONAL-F are used to make the body produce multiple egg sacs, allowing more eggs to be collected from women undergoing infertility treatment.

The main purpose of this trial is to see how many eggs are produced with a starting dose of 15 µg REKOVELLE compared to a starting dose of 225 IU GONAL-F. This research is intended to provide more knowledge about REKOVELLE, including the doses given in the trial.

Inclusion Criteria:

• Infertile women aged 18-40 years
• Diagnosed with tubal infertility, unexplained infertility, mild endometriosis (stage I/II) or partners with decreased sperm quality
• Medically eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI)
• Infertility for at least one year for participants ≤ 37 years or for at least 6 months for participants ≥ 38 years
• Regular menstrual cycles of 21-35 days.

Exclusion Criteria:

• Known condition of not functioning ovaries
• Known advanced endometriosis (stage III/IV)
• Considered unsuitable for controlled ovarian stimulation with a dosing regimen corresponding to approximately 225 IU/day gonadotropin, as judged by the investigator
• History of previous episode of OHSS or exuberant ovarian response to gonadotropins, and polycystic ovarian syndrome
• Any known hormonal or metabolic abnormalities which can compromise participation in the trial
• Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus