Study Protocol: Evaluating Cellular Fragmentation in Embryos Resulting from Intracytoplasmic Sperm Injection (ICSI): A Study of Degree, Pattern, Distribution, and Clinical Pregnancy Outcomes.

Background: Infertility affects approximately one in six couples worldwide, with assisted reproductive technologies (ART) providing effective solutions. Intracytoplasmic sperm injection (ICSI) is a widely used ART method; however, cytoplasmic fragmentation in embryos can influence implantation success and clinical pregnancy outcomes. The degree, pattern, and distribution of fragmentation remain crucial factors in embryo selection and success rates.

Objectives: This study evaluates cytoplasmic fragmentation in ICSI embryos and its impact on embryo development and pregnancy outcomes. The objectives include: assessing the extent of fragmentation in relation to implantation and pregnancy success, analyzing fragmentation patterns predictive of miscarriage or live birth, and standardizing measurement criteria for improved embryo selection in ART.

Methodology: This prospective observational study will be conducted at Wardha Test Tube Baby Center, AVBRH, Sawangi, over six months. The study will include couples undergoing ICSI, with embryo fragmentation assessed microscopically based on degree, pattern, and distribution. Clinical outcomes, including implantation rates and pregnancy success, will be analyzed using statistical methods such as Chi-square tests and regression analysis.

Expected result: It is anticipated that minimal fragmentation (<10%) will correlate with higher implantation and pregnancy rates, while severe fragmentation (>50%) will negatively impact outcomes. Localized fragmentation may have less detrimental effects than diffuse fragmentation, and inner cell mass fragmentation is expected to affect fetal development more significantly than trophectoderm fragmentation.

Study implication: This study will enhance understanding of fragmentation characteristics in ICSI embryos, contributing to improved embryo selection strategies and higher ART success rates. The findings may support refining embryo grading criteria to optimize clinical outcomes.