ROSI (Round Spermatid Injection) in Georgia

ROSI is a technically sophisticated and clinically debated assisted reproductive technique that may be regarded as a "last resort" in specific instances of male infertility when mature sperm cells are unavailable.

It is important to highlight that ROSI is not a standard treatment; success rates can differ considerably based on the center, laboratory expertise, and patient selection; additionally, information regarding safety and long-term outcomes is limited. Consequently, the decision-making process should involve the guidance of andrology/urology, reproductive endocrinology, and genetic counseling whenever feasible.

What is ROSI, and how does it differ from ICSI?

ROSI stands for "round spermatid injection"; in Turkish, it is known as "yuvarlak spermatid kurumu." The procedure involves the microinjection of round spermatid cells, which represent an earlier developmental stage of sperm, into the egg when mature sperm cells are absent in the semen or testicular tissue.

ROSI is distinct from the widely recognized ICSI (intracytoplasmic sperm injection) technique:

In ICSI, a mature sperm cell is directly injected into the egg.

ROSI utilizes an immature germ cell known as a round spermatid.

Due to this difference, ROSI may introduce greater uncertainty in the processes of precise cell identification, egg activation, embryo development, and achieving live birth. In clinical practice, it is regarded as less established than ICSI, and the outcomes are more variable.

For whom could this become a concern?

ROSI is typically regarded as a "last resort" for a very specific group of patients in whom mature sperm cannot be retrieved even from testicular tissue, particularly in cases involving conditions like non-obstructive azoospermia or spermatogenesis arrest.

Typically, the subsequent approach is taken into account prior to ROSI:

Comprehensive assessment of male infertility (medical history, physical examination, repeat semen analysis, ultrasound, etc.)

Hormonal assessment (e.g., FSH/LH/testosterone, prolactin; based on clinical context)

Genetic testing and counseling (as clinically required)

Micro-TESE is utilized to locate mature sperm and to prepare for ICSI if sperm is identified.

If mature sperm can be obtained, current evidence indicates that ICSI is typically more established and conducted with higher success rates in most centers. Conversely, ROSI is a more experimental alternative that may be considered in certain centers when mature sperm is not available.

Success rates

While pregnancies and live births have been documented with ROSI, outcomes can differ greatly based on the experience of the center, the selection of patients, the methods used for cell identification, and the protocols followed in the laboratory. Consequently, a singular “overall success rate” should not be regarded as relevant for every patient.

When assessing success, focusing exclusively on the fertilization rate may provide a distorted view. In ROSI, losses can happen at every phase: appropriate cell selection, egg activation, embryo development, achieving the transfer stage, and live birth.

Hazards and ambiguities

ROSI presents not only a reduced likelihood of success due to the utilization of immature cells but also the challenge of working with more restricted data concerning embryo development and long-term child health. While healthy births have been documented globally, the number of cases is lower in comparison to standard IVF/ICSI procedures, which complicates the ability to reach conclusive determinations about safety.

Data limitations — Results may not be applicable to a broader context due to the infrequency of the application and diverse protocols.

Laboratory reliance — The accuracy of cell identification and processing can greatly influence outcomes.

Interstage loss — Even if fertilization takes place, losses may occur during the stages of embryo development, transfer, or pregnancy.

Implementation in Georgia

Although there are facilities in Georgia that provide IVF and ICSI services, it is not always easily ascertainable from publicly accessible sources which facilities actually conduct ROSI, whether this service is consistently available, and what the clinical outcomes are. Consequently, a facility's claim that "we perform ROSI" should not be regarded as adequate on its own.

When considering ROSI, it is essential to obtain written experience and live birth data from the clinic. Additionally, it is important to specify the patient group that the data pertains to, the time frame it encompasses, and the criteria utilized for reporting.

Transparent data — ROSI cycle count, fertilization, transfer, clinical pregnancy, and live birth results.

Team and process — Processing of testicular tissue, selection of cells, and experience in embryology laboratory.

Cost and scope — This refers to whether the package includes items such as medications, anesthesia, genetic testing options, and freezing/transfer.

Questions to consider when meeting with the clinic

The questions listed below can assist in organizing the interview and enhancing the transparency of the decision-making process (it is advisable to request written responses):

Is ROSI a standard clinical service or a research/special case application?

How many ROSI cycles have you completed in the past 3 to 5 years?

How many fertilizations, embryo transfers, clinical pregnancies, and live births were accomplished? (What denominator was utilized to compute the rates?)

What methods are used to confirm that the cells in question are indeed round spermatids?

What protocols are utilized for egg activation? (Alternatives and indications, if applicable)

Who is responsible for the testicular tissue harvesting and cell selection process? (Urology/andrology and embryology team structure)

What insights do the embryology laboratory and the andrology team have concerning micro-TESE?

Is genetic counseling accessible? What are the possibilities and restrictions of embryo genetic testing?

Does the total cost include anesthesia, medications, embryo freezing, transfer, and any other procedures?

What alternative plans are proposed in the event of failure? (Micro-TESE + ICSI, research on frozen sperm, donor sperm, other options for beginning a family)

Conclusion

ROSI is a technique that may be viewed as a final option for biological parenthood in certain instances of azoospermia when mature sperm is unavailable. Nevertheless, it is not a standard treatment; the likelihood of success is typically low, and outcomes are significantly influenced by the center, team, and patient selection. The limited information regarding safety, embryo development, and long-term child health requires thorough evaluation of the decision.

Factors to take into account

Clarify the objective: “Fertilization” and “live birth” represent distinct outcomes; obtain data from the clinic for each phase.

The issue of the denominator: The ratios may seem different when expressed "per transfer," "per embryo," or "based on cycle start."

Discuss the alternatives: Evaluate options, including Micro-TESE combined with ICSI, possible repeat strategies, and associated costs.

Written consent and transparency: Documentation in writing is required for experimental or non-routine aspects, uncertainties, and center results.