Menopur And Rekovelle Combination Study

An Exploratory Study to Evaluate a Mixed Protocol of Menopur (Highly Purified Human Menopausal Gonadotropin) and REKOVELLE (Follitropin Delta) for Controlled Ovarian Stimulation in IVF (in Vitro Fertilization)

This study proposes to evaluate the effect of adding HP-hMG (Menopur) to follitropin delta in a "mixed protocol" regimen, using an individualized, fixed dose of follitropin delta based on the established algorithm, combined with a variable, adjustable dose of Menopur based on body weight and ovarian reserve.

The initial dose of follitropin delta will be determined at enrolment by the analysis of serum AMH on days 2 to 5 of the menstrual cycle preceding the IVF treatment cycle and body weight in Kg The initial dose of HP-hMG to be added on top of follitropin delta will be determined at enrolment by the total follitropin delta dose and body weight in Kg

Inclusion Criteria:

• Women 18 to 40 years of age undergoing their first IVF/ICSI cycle
• Diagnosed with unexplained infertility, tubal infertility, endometriosis stage I/II, or with partners diagnosed with male factor infertility
• Regular menstrual cycles of 24-35 days
• Presence of both ovaries
• Early follicular phase FSH serum concentration <10 IU/L measured between Day 2 to Day 5 of menstrual cycle within the previous 12 months
• Ejaculated sperm (fresh or frozen) for insemination

Exclusion Criteria:

• Inability to consent
• Endometriosis stage III and IV
• High risk of OHSS (AMH ≥ 35 pmol/L)
• History of recurrent miscarriages defined as ≥ 3 consecutive losses
• Women undergoing egg donation
• Women participating in any other research project
• Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle
• Hypersensitivity to follitropin delta and/or HP-hMG