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The use of intracytoplasmic sperm injection has increased substantially worldwide, primarily in couples with non-male factor infertility. However, there is a paucity of evidence from randomised trials supporting this approach compared with conventional in-vitro fertilisation (IVF). We aimed to investigate whether intracytoplasmic sperm injection would result in a higher livebirth rate compared with conventional IVF. This open-label, multicentre, randomised trial was done at two IVF centres in Ho Chi Minh City, Vietnam (IVFMD, My Duc Hospital and IVFAS, An Sinh Hospital). Eligible couples were aged at least 18 years and the male partner's sperm count and motility (progressive motility) were normal based on WHO 2010 criteria. Couples had to have undergone two or fewer previous conventional IVF or intracytoplasmic sperm injection attempts, have used an antagonist protocol for ovarian stimulation, and agree to have two or fewer embryos transferred. Couples were randomly assigned (1:1) to undergo either intracytoplasmic sperm injection or conventional IVF, using block randomisation with variable block size of 2, 4, or 8 and a telephone-based central randomisation method. The computer-generated randomisation list was prepared by an independent statistician who had no other involvement in the study. Embryologists and couples were not masked to study groups because of the type of interventions and differences in hospital fees, but clinicians performing embryo transfer were unaware of study group allocation. The primary outcome was livebirth after the first embryo transfer from the initiated cycle. Analyses were done on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03428919. Between March 16, 2018, and Aug 12, 2019, we randomly assigned 1064 couples to intracytoplasmic sperm injection (n=532) or conventional IVF (n=532). Livebirth after the first embryo transfer from the initiated cycle occurred in 184 (35%) of 532 couples randomly assigned to intracytoplasmic sperm injection and in 166 (31%) of 532 couples randomly assigned to conventional IVF (absolute difference 3·4%, 95% CI −2·4 to 9·2; risk ratio [RR] 1·11, 95% CI 0·93 to 1·32; p=0·27). 29 (5%) couples in the intracytoplasmic sperm injection group and 34 (6%) couples in the conventional IVF group had fertilisation failure (absolute difference −0·9%, −4·0 to 2·1, RR 0·85, 95% CI 0·53 to 1·38; p=0·60). In couples with infertility in whom the male partner has a normal total sperm count and motility, intracytoplasmic sperm injection did not improve the livebirth rate compared with conventional IVF. Our results challenge the value of the routine use of intracytoplasmic sperm injection in assisted reproduction techniques for this population. My Duc Hospital and Merck Sharp and Dohme.

Introduced in 1992, intracytoplasmic sperm injection (ICSI) was initially indicated for severe male infertility; however, its use has since been expanded to non-severe male infertility. We aimed to compare the efficacy and safety of ICSI versus conventional in-vitro fertilisation (IVF) in couples with infertility with non-severe male factor. We conducted an investigator-initiated, multicentre, open-label, randomised controlled trial in ten reproductive medicine centres across China. Couples with infertility with non-severe male factor without a history of poor fertilisation were randomly assigned (1:1) to undergo either ICSI or conventional IVF. The primary outcome was live birth after first embryo transfer. We performed the primary analysis in the intention-to-treat population using log-binomial regression models for categorical outcomes or linear regression models for continuous outcomes, adjusting for centre. This trial is registered with Clinicaltrials.gov, NCT03298633, and is completed. Between April 4, 2018, and Nov 15, 2021, 3879 couples were screened, of whom 2387 (61·5%) couples were randomly assigned (1184 [49·6%] to the ICSI group and 1203 [50·4%] to the conventional IVF group). After excluding couples who were ineligible, randomised twice, or withdrew consent, 1154 (97·5%) in the ICSI group and 1175 (97·7%) in the conventional IVF group were included in the primary analysis. Live birth after first embryo transfer occurred in 390 (33·8%) couples in the ICSI group and in 430 (36·6%) couples in the conventional IVF group (adjusted risk ratio [RR] 0·92 [95% CI 0·83–1·03]; p=0·16). Two (0·2%) neonatal deaths were reported in the ICSI group and one (0·1%) in the conventional IVF group. In couples with infertility with non-severe male factor, ICSI did not improve live birth rate compared with conventional IVF. Given that ICSI is an invasive procedure associated with additional costs and potential increased risks to offspring health, routine use is not recommended in this population. National Natural Science Foundation of China, National Key Research and Development Program, Beijing Municipal Science & Technology Commission, and Peking University Third Hospital.

Time-lapse imaging systems for embryo incubation and selection might improve outcomes of in-vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) treatment due to undisturbed embryo culture conditions, improved embryo selection, or both. However, the benefit remains uncertain. We aimed to evaluate the effectiveness of time-lapse imaging systems providing undisturbed culture and embryo selection, and time-lapse imaging systems providing only undisturbed culture, and compared each with standard care without time-lapse imaging. We conducted a multicentre, three-parallel-group, double-blind, randomised controlled trial in participants undergoing IVF or ICSI at seven IVF centres in the UK and Hong Kong. Embryologists randomly assigned participants using a web-based system, stratified by clinic in a 1:1:1 ratio to the time-lapse imaging system for undisturbed culture and embryo selection (time-lapse imaging group), time-lapse imaging system for undisturbed culture alone (undisturbed culture group), and standard care without time-lapse imaging (control group). Women were required to be aged 18–42 years and men (ie, their partners) 18 years or older. Couples had to be receiving their first, second, or third IVF or ICSI treatment and could not participate if using donor gametes. Participants and trial staff were masked to group assignment, embryologists were not. The primary outcome was live birth. We performed analyses using the intention-to-treat principle and reported the main analysis in participants with primary outcome data available (full analysis set). The trial is registered on the International Trials Registry (ISRCTN17792989) and is now closed. 1575 participants were randomly assigned to treatment groups (525 participants per group) between June 21, 2018, and Sept 30, 2022. The live birth rates were 33·7% (175/520) in the time-lapse imaging group, 36·6% (189/516) in the undisturbed culture group, and 33·0% (172/522) in the standard care group. The adjusted odds ratio was 1·04 (97·5% CI 0·73 to 1·47) for time-lapse imaging arm versus control and 1·20 (0·85 to 1·70) for undisturbed culture versus control. The risk reduction for the absolute difference was 0·7 percentage points (97·5% CI –5·85 to 7·25) between the time-lapse imaging and standard care groups and 3·6 percentage points (–3·02 to 10·22) between the undisturbed culture and standard care groups. 79 serious adverse events unrelated to the trial were reported (n=28 in time-lapse imaging, n=27 in undisturbed culture, and n=24 in standard care). In women undergoing IVF or ICSI treatment, the use of time-lapse imaging systems for embryo culture and selection does not significantly increase the odds of live birth compared with standard care without time-lapse imaging. Barts Charity, Pharmasure Pharmaceuticals, Hong Kong OG Trust Fund, Hong Kong Health and Medical Research Fund, Hong Kong Matching Fund.

Intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (c-IVF) are widely used fertilization techniques in assisted reproduction, but their relative effectiveness in patients without severe male factor infertility remains debated. While ICSI’s role in couples with severe male factor infertility is well established, its routine use in cases with normal or nonseverely decreased sperm quality is not evidence-based. Here we conducted the INVICSI study, an open-label, multicenter randomized controlled trial, to compare cumulative live birth rates (CLBR) as the primary outcome between ICSI and c-IVF in patients without severe male factor infertility. Between November 2019 and December 2022, 824 women undergoing their first IVF cycle were randomized to ICSI ( n  = 414) or c-IVF ( n  = 410) across six public fertility clinics in Denmark. The CLBR was 43.2% (179/414) in the ICSI group and 47.3% (193/408) in the c-IVF group, yielding a risk ratio of 0.91 (95% confidence interval, 0.79–1.06). These findings demonstrate that ICSI does not improve CLBR compared to c-IVF and support c-IVF as the preferred first-line treatment for patients with normal or nonseverely decreased sperm quality. ICSI should be reserved for severe male factor infertility. ClinicalTrials.gov registration: NCT04128904 . Intracytoplasmic sperm injection, usually reserved for cases of male infertility, was found to be nonsuperior to conventional in vitro fertilization in couples without male infertility concerns.

AbstractObjectiveTo assess the efficacy of preimplantation genetic testing for aneuploidies (PGT-A) compared to intracytoplasmic sperm injection (ICSI) alone in couples undergoing ICSI treatment because of severe male infertility.DesignMulticentre, open label, randomised controlled trial.SettingFour reproductive medicine centres across China.Participants450 couples with severe male factor infertility scheduled for ICSI were randomly assigned (1:1) to undergo PGT-A or not (225 couples in each group).InterventionsICSI with genetic testing of blastocysts before transfer in the PGT-A group, and ICSI without genetic testing for the no PGT-A group.Main outcome measuresPrimary outcomes were live birth after the first embryo transfer and cumulative live birth (up to three transfer cycles) within 12 months after randomisation. Primary analysis was based on intention-to-treat principle.ResultsBetween 15 July 2018 and 6 January 2023, 450 of 1347 screened couples gave informed consent and were randomised to the intervention, ICSI with PGT-A (n=225), or ICSI with no additional genetic testing (n=225). In total, 109 couples in the PGT-A group (48.4%) and 104 couples in the no PGT-A group (46.2%) had a live birth after the first embryo transfer (odds ratio 1.09 (95% confidence interval (CI) 0.76 to 1.58), P=0.64). The cumulative live birth rates per woman were 60.4% (136/225) and 60.9% (137/225) in the PGT-A and no PGT-A groups, respectively (0.98 (0.67 to 1.43), P=0.92). The PGT-A group had significantly lower rates of pregnancy loss after the first embryo transfer (13 (5.8%) PGT-A group v 43 (19.1%) no PGT-A group, 0.26 (0.14 to 0.50), P<0.001) and cumulative pregnancy loss (25 (11.1%) v 51 (22.7%), 0.43 (0.25 to 0.72), P=0.001) than the no PGT-A group.ConclusionPGT-A did not improve live birth rates in ICSI for severe male infertility compared to ICSI alone, but reduced rates of pregnancy loss.Trial registrationClinicalTrials.gov NCT02941965.

The effectiveness of PIEZO-ICSI (P-ICSI) compared to conventional ICSI (C-ICSI) is still controversial. The only confirmed effectiveness of P-ICSI compared to C-ICSI is that it can reduce the number of degenerated oocytes after ICSI. This study included 100 patients undergoing their first IVF cycle. The patients were randomly assigned to C-ICSI group and P-ICSI group, 50 patients per each group. A total of 2,434 oocytes were retrieved from 100 patients. Among them, 1,527 oocytes with visible meiotic spindle were inseminated by C-ICSI or P-ICSI (778 by C-ICSI, 749 by P-ICSI). Fertilization, degeneration after ICSI and blastocyst development were compared between the C-ICSI group and P-ICSI group. Among the embryos developed to blastocysts, good quality blastocysts were vitrified. The frozen-thawed embryo transfer (FET) cycles were carried out in 42 patients of C-ICSI group and in 45 patients of P-ICSI group. Clinical pregnancy outcomes were analyzed. The differences between C-ICSI group and P-ICSI group were statistically analyzed using Mann-Whitney U test or chi-Square test. Patient age was not different between C-ICSI group and P-ICSI group (33.5 ± 2.7 vs. 32.9 ± 2.4, P = 0.12114). Normal fertilization rate of P-ICSI group (584/749, 78.0%) was significantly higher than that of C-ICSI group (565/778, 72.6%, P = 0.0176). The oocyte degeneration rate after ICSI was significantly higher in C-ICSI group (49/778, 6.3%) than in P-ICSI group (24/749, 3.2%, P = 0.0055). Among the fertilized oocytes, 21 did not cleave; 14 were from C-ICSI group (2.48%) and 7 from P-ICSI group (1.20%, P = 0.1250). Blastocyst formation rate (65.5% vs. 67.8%, P = 0.4485) and the rates of blastocyst that were available for vitrification (59.3% vs. 62.6%, P = 0.2724) were not different between C-ICSI group and P-ICSI group. Blastocyst formation rate on day 5 was significantly higher in P-ICSI group (50.3%) than in C-ICSI group (43.9%, P = 0.0367). In FET cycles, average age of patients was 33.6 ± 2.6 years old in C-ICSI group and that was 32.9 ± 2.3 years old in P-ICSI group. The average number of transferred embryos was 1.5 ± 0.5 in C-ICSI group and 1.2 ± 0.4 in P-ICSI group. The clinical pregnancy rate and the abortion rate of C-ICSI group were 64.3% and 18.5%, respectively. Those of P-ICSI group were 66.7% and 23.3%, respectively. This study showed that normal fertilization rate, the survival of oocytes after ICSI and blastocyst formation rate on day 5 were significantly higher in P-ICSI group than in C-ICSI group. Developmental arrest of zygotes was lower in P-ICSI group than in C-ICSI group. The number of embryos available for vitrification can be increased by implementing P-ICSI. P-ICSI has the potential to improve the development of zygotes into blastocysts.

IntroductionIntracytoplasmic sperm injection (ICSI), originally introduced as add-on to in vitro fertilisation (IVF) for couples with severe male infertility, is in current clinical practice also used in couples with mild male or even unexplained infertility. However, ICSI has involved unresolved concerns regarding the selection and damage to gametes and the health conditions of the offspring, and it is also labour intensive and therefore more expensive than conventional IVF. High-quality well-powered randomised clinical trials (RCTs) comparing ICSI and IVF are lacking.Methods and analysisWe propose a multicentre, open-label RCT in 10 reproductive medical centres across China. We will study couples with non-severe male infertility (defined as a semen concentrate 5–15×106/mL or sperm with a progressive motility 10%–32%) scheduled for their first or second ICSI or IVF cycle, as low fertility rate after fertilisation are more frequent in this population, which could lead to controversy about ICSI or conventional IVF for fertilisation. On the day of oocyte retrieval, eligible participants are after informed consent be randomised to undergo either ICSI or conventional IVF in a 1:1 treatment ratio. Other standard assisted reproductive treatments are similar and parallel between two groups. Our primary outcome is ongoing pregnancy leading to live birth after the first cycle with embryo transfer. To demonstrate or refute a difference of 7% between ICSI and conventional IVF, we need to include 2346 women (1173 in each intervention arm). In addition, we will follow-up neonatal outcomes after delivery to identify the influence of ICSI on offspring.Ethics and disseminationEthical approval was obtained from Peking University Third Hospital medical science research ethics committee. The findings will be disseminated to the public through conference presentations and peer-reviewed scientific journals.Trial registration numberClinicalTrials.gov registry (NCT03298633).

ObjectivesThis study aimed to evaluate the role of intracytoplasmic sperm injection (ICSI) in the treatment of non-male factor infertile patients aged ≥ 39.MethodsThis is a single-center, prospective, randomized controlled clinical trial, between March 2018 and December 2019. Sixty-nine patients were recruited, and sixty patients participated in the study. Their ovaries were randomized prior to the beginning of the ovarian stimulation: the oocytes from one side (n = 257) were allocated to the ICSI (ICSI arm), while those of the contralateral side (n = 258) were allocated to conventional insemination (IVF arm). The fertilization rate per oocyte retrieved, number of zygotes (2PN), and cleavage-stage embryos were assessed and compared between the two study groups.ResultsThe average number of zygotes (3.1 vs. 2.7 p = 0.45), the fertilization rate (72.4% vs. 65.1% p = 0.38), the average number of cleavage-stage (2.8 vs. 2.4 p = 0.29), and the average top-quality embryos (TQE) cleavage-stage embryos (1.7 vs. 1.6 p = 0.94) were comparable between the two groups. The TQE rate per randomized oocyte (41.2% vs. 41% p = 0.8) was also similar in both groups.ConclusionsICSI does not improve the reproductive outcomes of advanced-age patients undergoing conventional insemination for non-male factor infertility.Trial registrationNCT03370068

PurposeTo evaluate the efficacy of magnetic-activated cell sorting (MACS) or testicular sperm aspiration (TESA) to improve reproductive outcomes in cases with elevated sperm DNA fragmentation undergoing assisted reproduction.MethodsThis randomized controlled trial included couples with failed IVF cycles and sperm DNA fragmentation > 30%. Sperm DNA fragmentation was assessed using the sperm chromatin structure assay (SCSA) method. Participants were randomly assigned to either the MACS or TESA group. Testicular sperm retrieval was performed for the TESA group, while MACS involved sperm selection using magnetic beads. Extended blastocyst culture, freeze all policy of blastocysts by vitrification, and frozen embryo transfer were undertaken as per clinic’s standard operating protocols. Blastocyst formation rate, implantation rate, miscarriage rate, multiple pregnancy rate, and live birth rate were analyzed and compared between MACS and TESA groups.ResultsThere were no significant differences in female age, male age, or sperm DNA fragmentation index (DFI) between the MACS and TESA groups. The blastocyst conversion rate was slightly higher in the TESA group (39%) compared to the MACS group (32%). However, the MACS group had a higher implantation rate (50%) than the TESA group (35%). Miscarriage rates, multiple pregnancy rates, and live birth rates did not show statistically significant differences between the groups. A chi-squared test was conducted to compare categorical variables, and t-tests were done to compare continuous variables.ConclusionIn cases with raised sperm DNA fragmentation, sperm selection by MACS or TESA seems to offer comparable reproductive outcomes. There seems no superiority of one intervention over the other in cases with raised sperm DNA fragmentation undergoing assisted reproduction. Both interventions seem to be beneficial for couples seeking assisted reproduction with raised sperm DNA fragmentation.

The research investigated the capacity of myo-inositol (MI) in order that it improves biochemical markers in serum and follicular fluid and, ultimately, intracytoplasmic sperm injection (ICSI) outcomes of women with PCOS. Sixty infertile patients with PCOS, who were undergoing ovulation induction for ICSI, were randomly divided to two groups . The MI group received 2000 mg myo-inositol + 1 mg folic acid twice a day for 6 weeks with starting the ICSI cycle. For the same period, the control group received a placebo containing only folic acid (1 mg). Levels of hormonal profiles in serum and follicular fluid, as well as oxidative stress markers (MDA, TAC, GPx, and SOD), were estimated using an ELISA assay. Primary end points were ICSI cycle outcomes. Compared to the placebo group, the MI group demonstrated significant reduction in serum and follicular fluid levels of LH, LH/FSH ratio, total testosterone, AMH, and androstenedione. Furthermore, the MI group exhibited meaningful increases in TAC, GPx, and SOD, but MDA significantly decreased. While the number of retrieved and mature oocytes is not statistically similar among the groups, the MI group showed significant improvements in the percentage of immature oocytes, cleavage rate, and good embryo quality. A meaningful correlation was checked between follicular fluid AMH level and LH, FSH, total testosterone, androstenedione, insulin, MDA, the number of retrieved oocytes, and immature oocytes. Our outcomes indicate that myo-inositol administration in women with PCOS undergoing ART helps to improve their hormonal profiles, and the quality of oocytes and embryos. Registration details: Date: 2022.10.19, Registry: https://irct.behdasht.gov.ir/trial/66005 , and Trial registration: IRCT202220921056008N1.