Overview
This is a prospective, randomized, single center, phase 4 controlled trial. The study will compare the efficacy of two different strategies for the management of predicted poor response patients under stimulation for IVF/ICSI: up to three MNC cycles (group 1) versus a single GnRH antagonist CFA (group 2).
Eligibility
Inclusion Criteria:
- 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.
- Poor responders as defined according to the POSEIDON criteria:
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).
Exclusion Criteria:
- 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.
- Ovarian cysts or enlarged ovaries.
- 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.