Clinical Research Directory

Inclusion Criteria: * Women aged 18 to 40 years inclusively at the time of consent form signature * Diagnosis of unexplained infertility, tubal infertility, endometriosis stage I/II or 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 and Day 5 of menstrual cycle within the previous 24 months * First IVF/ICSI cycle * IVF antagonist protocol prescribed * Partner or donor ejaculated sperm (fresh or frozen) used for fertilization Exclusion Criteria: * Women undergoing oocyte donation * Endometriosis stage III/IV * High risk of OHSS (AMH ≥ 35 pmol/L) * Body Mass Index (BMI) \> 40 kg/m2 Protocol number: IIS-1056 MARCS 2.0 Study Version: 1.1 - Date : 14 APR 2025 Page 12 of 28 * Gynaecological haemorrhages of unknown aetiology * History of recurrent miscarriages defined as ≥ 3 consecutive losses * Renal or hepatic impairment * Hypersensitivity to any active ingredient or excipients in follitropin delta and/or HP-hMG * Tumours of hypothalamus or pituitary gland * Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome * Current or history of ovarian, uterine or mammary carcinoma * History of thrombophilia * Use of hormonal preparations (except for 17β-estradiol, testosterone gel, DHEA and thyroid medication) during the last menstrual cycle * Women participating in any other interventional research project