ICSI vs IVF with Normal Sperm Quality

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ICSI vs IVF with normal sperm quality

Intracytoplasmic sperm injection versus conventional in-vitro fertilisation in couples with infertility in whom the male partner has normal total sperm count and motility: an open-label, randomised controlled trial

A large multi-centre randomised trial was initiated to compare intracytoplasmic sperm injection (ICSI) versus conventional IVF, in infertile couples, where the male partner has normal total sperm count and motility.

Couples were recruited from two IVF centres (IVFMD and IVFAS) in Ho Chi Minh City, Vietnam. Total sperm count and (progressive) motility was based on WHO criteria (TSC ≥ 39 ×106, progressive motility ≥ 32%).

Only couples who had undergone 2 or fewer previous IVF/ICSI cycles, used the antagonist protocol for ovarian stimulation, and agreed to have 2 or fewer embryos transferred were eligible, whilst couples with poor oocyte fertilisation previously (≤ 25%) and or using frozen semen were excluded. Women with PCOS or oocyte maturation triggered by gonadotropin-releasing hormone agonist were included to increase the generalisation of the study.

In this trial, controlled ovarian stimulation was carried out using a follicle-stimulating hormone and gonadotropin-releasing antagonist protocol. Once 3 or more follicles reached a diameter of 17µm, ovulation was triggered using human chorionic gonadotropin (hCG), or gonadotropin-releasing hormone agonist in those at risk of OHSS, followed by oocyte retrieval 36 hours later.

On the day of oocyte retrieval, semen samples were collected and prepared by discontinuous density gradient centrifugation, with the swim-up technique step added to conventional IVF semen samples. In the conventional IVF group, oocytes were inseminated 2 hours post-retrieval in a concentration of 100,000 motile sperm/mL for 2 hours. Similarly, to keep time to insemination comparable in the ICSI group, intracytoplasmic sperm injection was done 3 to 4 hours after oocyte retrieval.

Fresh or frozen-thawed embryo transfer was then carried out on day 3 (cleavage stage) with progesterone (fresh) or progesterone + estradiol (frozen) given for luteal phase support until gestation week 7 or 12 dependent on pregnancy test results.

Primary study outcome was livebirth after the first embryo transfer, defined as the birth of at least one live neonate after 24 weeks gestation. In cases where no embryo was available for transfer, the cycle was considered a failure.

In total, 1064 eligible couples were evenly randomized to undergo IVF or ICSI cycles. Forty three couples changed their cycle preference, culminating in 571 couples allocated to ICSI group and 493 couples to IVF.

Initial baseline characteristics of the 2 groups showed no significant differences between the couples. For reference 90% of couples had not undertaken IVF or ICSI previously.

After insemination or injection, fertilisation rates per oocyte inseminated or injected was significantly higher in the ICSI group (75.0%) compared to IVF (66.7%), however this did not translate into significantly higher clinical pregnancy rates (43% vs 40%, P = 0.38) or livebirth rates (35% vs 31%, P = 0.27). Interestingly abnormal fertilisation per oocyte inseminated or injected was also significantly lower (1.3 vs 7.4%) in the ICSI group.

On the other hand, pregnancy complications (ectopic pregnancy, miscarriage, twin pregnancy or delivery), along with obstetric and perinatal outcomes, did not differ significantly between the 2 groups, although the study was underpowered to draw any conclusions for these specific outcomes.

At the end of 12 months, cumulative livebirth rate was 42% and 41%, in the ICSI and IVF groups respectively. Similarly median time to ongoing pregnancy resulting in livebirth, did not differ significantly, 178 vs 180 days for ICSI and IVF respectively.


In this trial comparing ICSI to IVF cycles, where male partners had normal sperm quality, fertilisation rate per oocyte was significantly higher in ICSI cycles (75.0 vs 66.7%). On the other hand clinical pregnancy rate and livebirth rate per cycle was not significantly different (P > 0.2).


  1. Day 3 embryo transfer only
  2. Sperm morphology and DNA fragmentation not evaluated
  3. Study size limited statistical significance to 10% difference

Similar studies

Supramaniam P R, et al. (2020). ICSI does not improve reproductive outcomes in autologous ovarian response cycles with non-male factor subfertility. https://doi.org/10.1093/humrep/dez301

Drakopoulos P, et al. (2019). ICSI does not offer any benefit over conventional IVF across different ovarian response categories in non-male factor infertility: a European multicenter analysis. https://doi.org/10.1007/s10815-019-01563-1

Sunderam S, et al. (2019). Comparing fertilization rates from intracytoplasmic sperm injection to conventional in vitro fertilization among women of advanced age with non-male factor infertility: a meta-analysis. https://doi.org/10.1016/j.fertnstert.2019.09.035

Li Z, et al. (2018). ICSI does not increase the cumulative live birth rate in non-male factor infertility. https://doi.org/10.1093/humrep/dey118

Tannus S, et al. (2016). The role of intracytoplasmic sperm injection in non-male factor infertility in advanced maternal age. https://doi.org/10.1093/humrep/dew298


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