Abstract
In assisted reproduction treatments (ART), applying the ICSI method for fertilization of oocytes rather than traditional IVF method, is regarded as controversial for two reasons, namely utility and safety. Our study examines an IVF-ICSI Split model for couples with unexplained infertility, where male factor is meticulously excluded and ART is conducted by a strict algorithm, a commitment to blastocyst culture, along with single embryo transfers and a high commitment to cryopreservation. From 242 treatment cycles, 3346 oocytes recovered (13.8 per OPU) were randomly allocated to IVF or ICSI and the fertilization rates standardized to the number of 2PNS arising from each group applying the metaphase II oocyte number identified for the ICSI group, as the denominator for both groups. The fertilization rates were significantly higher overall for ICSI (83.2% vs 65.4%; p<0.0001), being most pronounced for women under 40 years. The resultant embryos had equivalent implantation rates in both fresh ET and frozen (FET) cycles with no significant differences in pregnancy rates, miscarriage rates or live birth outcomes indicating equivalent embryo quality. However, there were significantly higher numbers of ICSI-generated embryos cryopreserved and subsequent FET procedures showed higher live birth rates (21 births vs 6 births; p<0.005) and potential livebirths (214 births vs 104 births; p<0.0001). No congenital fetal abnormalities were detected in any of the 199 babies delivered during the study period to December 2020, neither IVF-generated nor ICSI-generated. Whilst the data strongly favors ICSI, there were 2 women (from 26 with fertilization in one arm only) who demonstrated fertilization only in the IVF arm of the study. We conclude that the IVF-ICSI Split model should be undertaken on all IVF-naïve women with unexplained infertility to determine the appropriate fertilization mode, albeit ICSI will be safely preferred for >90% of cases.
Highlights
In vitro fertilization (IVF) has become a popular treatment mode for infertility due to female factors since it first success in 1978 [1,2,3,4,5,6,7,8]
Our study examines an IVF-ICSI Split model for couples with unexplained infertility, where male factor is meticulously excluded and assisted reproduction treatments (ART) is conducted by a strict algorithm, a commitment to blastocyst culture, along with single embryo transfers and a high commitment to cryopreservation
From 242 treatment cycles, 3346 oocytes recovered (13.8 per oocyte pick-up (OPU)) were randomly allocated to IVF or ICSI and the fertilization rates standardized to the number of 2PNS arising from each group applying the metaphase II oocyte number identified for the ICSI group, as the denominator for both groups
Summary
In vitro fertilization (IVF) has become a popular treatment mode for infertility due to female factors since it first success in 1978 [1,2,3,4,5,6,7,8]. It is estimated more than 10 million infants have been derived from the IVF±ICSI methodologies These historical advances in managing infertility caused some trepidation as numerous physiological processes have become sequentially bypassed. Even at the OCC site, several complex natural processes are bypassed when ICSI is utilized These include hyperactivated motility [27], the acrosome reaction [28], cumulus dispersal [29], sperm-zona binding and sperm penetration followed by sperm-oolemma binding [30,31]. These processes ensue in response to oocyte-sperm activation, the molecular events being well summarized recently [32,33]. Studies on non-human primates may be of concern, revealing ICSI may potentially affect pronuclear orientation, cleavage patterns, and microtubule configurations (which influence zygote polarity and embryonic axes) [35,36,37]
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