Effectiveness and Patient Compliance of a Needle-Free Injection System in Controlled Ovarian Stimulation in IVF Cycles: A Real-World, Investigator-Initiated, Retrospective, Multicenter, Observational Study.

Background Limited literature exists supporting the use of a needle-free injection system (NFIS) for in vitro fertilization (IVF) cycles, highlighting an unmet need for painless drug delivery to improve patient compliance and reduce treatment dropouts. We evaluated the effectiveness and patient compliance of NFIS for administering gonadotropins for controlled ovarian stimulation (COS) in IVF-embryo transfer (IVF-ET) cycles. Methods This real-world study included female patients aged ≥21 years who underwent COS in IVF-ET cycles from December 2025 to February 2026. Patients received either recombinant follicle-stimulating hormone (r-FSH) (Group-1) or r-FSH with highly purified human menopausal gonadotropin (hMG) (Group-2). The endpoints were the number of mature oocytes and total oocytes retrieved, total dose of gonadotropins used, total number of days of stimulation, serum FSH levels (on day 6 of stimulation and on the day of trigger), total number of follicles >17 mm on the day of trigger, and pain score. Results Of 43 patients analyzed (Group-1: 25; Group-2: 18), the mean ± SD total number of days of ovarian stimulation was 10.0 ± 1.2, and the total dose of gonadotropins used was 2458.7 ± 617.8 IU. The total number of days of ovarian stimulation was 10.0 ± 1.0 and 10.1 ± 1.5, and the total dose of gonadotropins used was 2203.9 ± 554.2 IU and 2812.5 ± 530.5 IU, for Group-1 and Group-2, respectively. Similarly, serum FSH levels at day 6 of COS were 18.1 ± 4.4 and 27.8 ± 0.0 IU/L, and on the day of ovulation trigger were 15.8 ± 6.0 and 36.0 ± 28.3 IU/L. Total number of follicles >17 mm on the day of trigger was 12.2 ± 6.5 in Group-1 and 4.8 ± 4.1 in Group-2. Total number of oocytes was 13.4 ± 6.2 and 6.1 ± 7.6, and the total number of metaphase II oocytes retrieved was 11.0 ± 5.4 and 4.8 ± 6.3 for Group-1 and Group-2, respectively. The pain score for administering r-FSH via NFIS in both groups was 1.2 ± 1.3, and for hMG via NFIS in Group-2, it was 3.6 ± 2.2. Conclusion NFIS was effective for administering gonadotropins for COS in IVF-ET cycles while ensuring patient compliance with minimal pain.