Frequently Asked Questions

There are a number of reasons that IVF and Assisted Reproductive Technology (ART) are becoming more common. These include the overall decline in the global fertility rate (decline in both male fertility, and female fertility as women postpone the age they try to conceive); the rising number of fertility clinics worldwide; technological advancements; and increasing public-private investments, funds, and grants.

The world is experiencing a major fertility crisis, caused by both sociological and environmental circumstances. If the current rate of male infertility decline continues, researchers predict that 50% of men will be infertile by 2045. 

An estimated 15% of couples will have trouble conceiving. Globally, 48.5 million couples experience infertility.

Due to these factors, IVF is becoming far more popular. In the US alone, 60% of respondents to an infertility survey stated that they had received some form of fertility treatment. Today 1 in 8 couples require IVF.
In 2019, 2.5 million IVF procedures were performed globally. At the forecasted growth rate of 10% annually, the number of procedures is expected to double and reach 5 million by 2026. According to Swan & Colino (2021), most couples may have to use assisted reproduction. 

Although the use of Assisted Reproductive Technology (ART) is still relatively rare compared to potential demand, its use has more than doubled over the past decade in the US alone.

The average cost of an IVF cycle in the US is $12,400 US. This does not include the cost of advanced treatments or related medications and drugs required. The average cost of the first IVF cycle in the US is $19,234 US. The global average direct cost for a single IVF cycle is $4,950 US.

According to this figure, the treatment market size is expected to reach $25 billion US dollars in 2025, and the total global fertility market expected to reach $52 billion.

Intracytoplasmic Sperm Injection (ICSI) is an Assisted Reproductive Technology (ART) procedure, in which, unlike in-vitro fertilization (IVF), a single spermatozoon is injected directly into the cytoplasm of an egg using very fine micro-manipulation equipment.

ICSI is one of the most common techniques used in assisted reproductive technology. Prevalence of ICSI is constantly rising, with over 80% of current ART cycles using ICSI, as opposed to IVF.
For cycles with male factor infertility, ICSI use increased from 76.3% in 1996 to 93.3% in 2012*.
For cycles without male factor infertility, ICSI use increased from 15.4% in 1996 to 66.9% in 2012*.

ICSI was pioneered in 1991 by Dr. Gianpiero Palermo, a Professor of Embryology in Obstetrics and Gynecology, and his team.

In natural fertilization, sperm compete and when the first sperm penetrates the oolemma, the oolemma hardens to block the entry of any other sperm. Concern has been raised that in ICSI, this sperm selection process is bypassed and the sperm is selected by the embryologist without any specific testing. Findings from some but not all studies suggest that ICSI is associated with an increased risk for chromosomal abnormalities, autism, intellectual disabilities, and birth defects compared with conventional IVF.

* https://www.cdc.gov/art/key-findings/icsi.html

According to the American Society for Reproductive Medicine, ICSI is a safe and effective procedure for couples with male factor infertility (around 50%). ICSI can improve the chance of fertilization for couples with poor fertilization in a previous IVF cycle.

As evident from the images on this website, examining a spermatozoon using a special microscope with high magnification (x6,100) shows morphological defects that cannot be observed in standard magnification. These morphological defects were found to be correlated with DNA methylation and the expression of many genes. 

Furthermore, using high magnification was shown to improve clinical and perinatal outcomes. Most importantly, the use of high magnification seems to be an effective tool for reducing the incidence of structural defects.

In a meta-analysis study, the incidence of birth defects was statistically different, with 2.5% in high magnification and 4.5% in standard magnification.

The benefits of injecting a selected spermatazoon include:

  • Higher fertilization rate
  • Sperm quality is a critical factor for embryo development to blastocyst stage
  • Higher pregnancy and birth rates
  • Decreased birth defects
  • The spermatozoon delivers a novel epigenetic signature to the egg (Miller et al, 2010)

The robotic system makes the sperm collection process more efficient.
It can complete the collection of the required number of spermatozoa quickly, accurately and at a higher level of consistency than a human can.

Clinical tests are run on numerous cases, to prove safety, similar to any other medical device. 

AI algorithms are already used for image decoding tasks such as CT and MRI images. In a similar way, at BAIBYSTM the algorithms are used to continuously check the sperm images, in order to detect morphological defects. Unlike an embryologist who performs a similar assessment, AI algorithms do so quickly, consistently (without fatigue, concentration demands, or human error issues), and according to uniform standards.
  • Proprietary algorithms processes the video stream of “live” sperm in real time
  • Autonomously classifies sperm cells based on their morphology and motility at high magnification (×6,100)
  • The algorithm controls the motorized X-Y stage in real-time to maintain the selected sperm cell in the middle of the field of view

No, not all spermatozoa are equal. Most are unsuitable for fertilization, and many have DNA fragmentation. 

It can take a trained embryologist 1-3 hours to select sperm under high magnification, as opposed to minutes under normal magnification. 

This makes selection under high magnification by embryologists an expensive, tedious, and subjective process.

Yes, the technology used in BAIBYS’ system is patent protected.