A randomized comparison of one controlled ovarian stimulation with corifollitropin alfa (CFA) versus up to three modified natural cycles (MNC) in expected and established poor responders - MONACO

niversitair Ziekenhuis Gent0 个研究点目标入组 300 人开始时间: 2024年6月14日最近更新: 2024年7月22日

适应症

试验速览

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•women with a clinical indication for ART with an expected low response to ovarian stimulation. Expected low prognosis will be defined according to the POSEIDON classification, which stratifies patients according to whether they have an unexpected (groups 1 and 2) or expected (groups 3 or 4) inappropriate ovarian response to gonadotropin stimulation. This trial only includes patients fulfilling the criteria of groups 3 or 4: • POSEIDON Group 3: patients < 35 years with poor ovarian reserve pre-stimulation parameters (AFC < 5 or AMH < 1.2 ng/ml*) • POSEIDON Group 4: patients = 35 years with poor ovarian reserve pre-stimulation parameters (AFC < 5 or AMH < 1.2 ng/ml*) * AMH value should not be older than 12 months., Informed consent form (ICF) dated and signed, Age = 18 and < 45 years old, Body Mass Index (BMI) = 18.5 kg/m² and < 35 kg/m², Regular menstrual cycles (between 21 and 35 days), Two ovaries present, Current pregnancy-wish, Single embryo transfer (SET)

•Basal FSH > 20 IU/L in the last 12 months, Simultaneous participation in another clinical study, Untreated and uncontrolled thyroid dysfunction, Tumors of the ovary, breast, uterus, pituitary or hypothalamus, Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause, Malformations of the reproductive organs, Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy, Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin), Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation

发起方

niversitair Ziekenhuis Gent