A Randomized Controlled Trial Comparing Intracytoplasmic Sperm Injection and Conventional In Vitro Fertilization Outcomes in Patients With Advanced Maternal Age

Abstract

Background: The most widely used fertilization treatment globally is intracytoplasmic sperm injection (ICSI), which is now indicated for a broader range of conditions. This study was designed to assess the outcomes of ICSI and conventional in vitro fertilization (c-IVF) specifically in advanced maternal age (AMA) patients.

Methods: This randomized controlled study included 70 women aged 39 - 44 years with a body mass index (BMI) of 18 - 35 kg/m² and partners with normal semen parameters. After informed consent, each patient’s ovaries were randomized before stimulation: oocytes from one ovary (n = 250) underwent ICSI, and those from the other (n = 250) underwent conventional IVF.

Results: The average daily gonadotropin dose was 351.5 IU, with ovarian stimulation lasting about 9.7 days. Baseline follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were 9.1 and 4.9 IU/L, respectively. Semen parameters included a volume of 2.1 mL, concentration of 72.5 million/mL, 59.7% motility, and 5.2% normal morphology. An average of 7.1 oocytes were retrieved per patient. In the ICSI and c-IVF groups, 71.2% and 72.4% of oocytes formed zygotes, with similar cleavage and top-quality embryo rates. Embryo transfers occurred in 54.8% (ICSI) and 57.6% (c-IVF) of cases. No substantial disparities were detected between the groups concerning their clinical and ongoing pregnancy rates.

Conclusions: In women aged 39 - 44 with normal sperm parameters, this study found no substantial variation in fertilization, embryo quality, or pregnancy rates between ICSI and c-IVF. Thus, ICSI offers no clear advantage over c-IVF in this population, suggesting that c-IVF remains a viable and effective option for patients with AMA.