A prospective, multicenter, randomized, evaluator-blind, positive-controlled, noninferiority clinical study (IIT) to evaluate the efficacy and safety of follicle-stimulating hormone aN01 (Shengnuowa) in assisted reproduction in patients with ovarian hyporesponsiveness (POR).

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: control group:Short acting FSH+ antagonist;test team:RhFSH‐CTP+ short‐acting FSH+ antagonist; CONDITION: Poor Ovarian Response (POR) PRIMARY OUTCOME: Number of oocytes obtained; SECONDARY OUTCOME: Persistent pregnancy rate;Clinical pregnancy rate;fertilization rate;Number of high‐quality embryos;Treatment compliance;Number of MII oocytes obtained;Serum ß ‐human chorionic gonadotropin (ß‐hCG) positive rate;Planting rate; INCLUSION CRITERIA: 1. Age 20‐45 years (inclusive), female; 2. Meet at least one of the following two items: (1)The ovarian response in the previous IVF cycle was low, and the number of eggs obtained in the conventional scheme was <=3; (2) Decreased ovarian reserve [sinus follicle number (AFC) < 5‐7 or anti‐Mü llerian hormone (AMH) < 0.5‐1.1µ g/L] (AFC must be the bilateral result calculated on the 2nd‐4th day of menstrual cycle, with a diameter of 2‐10mm, including the boundary value); 3. BMI 18‐30 kg/m (including the boundary value); 4. Both husband and wife have informed consent, voluntarily participate in the experiment and sign the informed consent form;
Epistemonikos ID: 64ac33c4691c90f99c8ffb47dc32a7fb73f38e29
First added on: Oct 08, 2026