Abstract
The purpose was to determine any difference in outcomes, primarily in terms of number of retrieved oocytes per procedure, between two different needles used for oocytes retrieval procedure in Assisted Reproductive Technologies: the single-lumen needle (SLN) versus the double-lumen needle (DLN) with follicle flushing after aspiration. This randomized controlled trial included oocyte retrieval (OR) cycles for IVF and ICSI performed in 18 to 42-year-old women between March 2019 and January 2021 at a tertiary-care Fertility Center. A total of 200 ORs were randomized, 100 in each group. The mean number of retrieved oocytes was not different between groups (10.2 ± 6.5 for DLNs vs. 10.7 ± 7.0 for SLNs, p = 0.810). No significant differences were observed also in terms of number of retrieved oocytes/punctured follicles (83.0% ± 27.0% vs. 81.0% ± 22.0%, p = 0.916), number of retrieved oocytes/follicles at trigger (78.0% ± 29.0% vs. 78.0% ± 27.0%, p = 0.881), number of mature oocytes (7.6 ± 5.3 vs. 8.0 ± 5.1, p = 0.519), and pregnancy rate (27% vs. 23%, p = 0.514). However, the time required to retrieve each oocyte was longer using the DLN (1.5 ± 1.3 vs. 1.1 ± 0.9 minutes, p = 0.002). The present study confirmed the new perspectives on the sole use of SLNs in terms of saving time, without affecting the number of retrieved oocytes. Trial registration number and date of registration NCT03611907; July 26, 2018.
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Datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.
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Dataset underlying this article is available in Zenodo repository and can be accessed, upon reasonable request to the corresponding author, since it includes sensitive data.
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Acknowledgements
The authors thank all the embryologists and gynecologists working at Humanitas Fertility Center, Rozzano, Milan, Italy.
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Camilla Ronchetti, Federico Cirillo, and Paolo Emanuele Levi-Setti were involved in the study concept and design. Valentina Immediata, Clara Gargasole, Valeria Scolaro, and Emanuela Morenghi contributed to the acquisition of data. Federico Cirillo, Camilla Ronchetti, and Emanuela Morenghi analyzed data. Federico Cirillo, Camilla Ronchetti, and Paolo Emanuele Levi-Setti wrote the manuscript and had a primary responsibility for final content. Emanuela Morenghi and Paolo Emanuele Levi-Setti supervised the analysis. Camilla Ronchetti contributed to bibliography updating. Pasquale Patrizio and Elena Albani critically revised the manuscript and helped for data analysis. All authors read and approved the final manuscript.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional Humanitas research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Bioethics Committee of Humanitas institutional review board on January 23rd, 2018.
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Ronchetti, C., Cirillo, F., Immediata, V. et al. A Monocentric Randomized Controlled Clinical Trial to Compare Single- and Double-Lumen Needles in Oocyte Retrieval Procedure in Assisted Reproductive Technologies. Reprod. Sci. 30, 2866–2875 (2023). https://doi.org/10.1007/s43032-023-01232-w
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DOI: https://doi.org/10.1007/s43032-023-01232-w