Prospective Randomized Sibling-Oocyte Trial Comparing Fertilization and Embryo Development Outcomes Between Intracytoplasmic Sperm Injection (ICSI) and Conventional IVF Using Frozen Donor Sperm

What this Trial Is About

Researchers are evaluating two fertilization methods—intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (IVF)—to determine which leads to better embryo development using frozen donor sperm in people without male fertility issues. This randomized, sibling-oocyte controlled trial aims to find out whether one method creates more usable embryos, affects fertilization success, or improves embryo quality and early pregnancy rates. The study focuses on non-male factor infertility cycles and addresses the clinical debate about routine ICSI use in these cases. Participants will have their mature eggs divided into two groups: one fertilized by ICSI, where a single sperm is directly injected into each egg, and the other by conventional IVF, where eggs are mixed with frozen-thawed donor sperm in culture for 16-18 hours. The assignment of eggs to each method is randomized within each participant. Embryos from both methods will be cultured under identical lab conditions and assessed for fertilization, blastulation, embryo quality, and early pregnancy outcomes. During the study, participants will continue their regular fertility treatment. Researchers will monitor outcomes such as the blastulation rate, fertilization rate, incidence of total fertilization failure, proportion of high-quality blastocysts, and early clinical pregnancy rate confirmed by ultrasound. The study will use statistical methods to compare results within each participant. Data confidentiality and regulatory standards will be maintained throughout the study, which is expected to enroll about 178 participants over 12 months.

SISTER: Sibling Oocyte Insemination With Frozen Sperm From Third Party Donors: Evaluation of Reproductive Techniques