Q: What kits are available?

A:Currently, we have two kits available:

Sperm Screen Kit (Double Density Gradient wash 40/80)

Sperm Prime Kit (Sperm Wash Media)

Q: What is the content of each kit?

A: The sperm Screen Kit contains:

Sperm Prime Wash 10*5ml (Sperm Prime is a sterile balanced salt solution, HEPES-buffered semen wash medium with Human Serum Albumin (HSA))

Sperm Screen Upper Layer 40% 10*1ml (Sperm Screen is an isotonic gradient for semen preparation with silane-coated colloidal silica particles suspended in HEPES Buffered Isotonic Salt Solution)

Sperm Screen Lower Layer 80% 10*1ml (Sperm Screen is an isotonic gradient for semen preparation with silane-coated colloidal silica particles suspended in HEPES Buffered Isotonic Salt Solution)

Sperm Prime Kit contains 10*5ml and 1*100ml (Sperm Prime is a sterile balanced salt solution, HEPES-buffered semen wash medium with Human Serum Albumin (HSA))

Q: Is this media manufactured by Shivani?

A: The media is manufactured at an environmentally controlled ISO9001 & ISO13485 certified facility in EUROPE. It is repackaged and labeled at our world-class state-of- the-art ART Medical Devices Facility in Mira, Mumbai-104, India.

Q: What tests are conducted during preparation and packing?

A: Sterility tests (bacterial & fungal screening) and physical examination.

Q: What is the temperature requirement for the kit and storage instructions?

A: Store at +2°C to +8°C at all times and protect it from sunlight.

Q: What are the advantages of using the Sperm Screen Kit?

A: The Sperm Screen Kit offers a safe, potential, efficient, and convenient approach to sperm preparation. It is a ready-to-use 3-in-1 kit for gradient separation. Each Sperm Screen Kit is sufficient for 10 samples of 1ml semen.

Q: How do we maintain the cold chain during shipment/transit?

A: We transit and ship our products in cold chain cargo, maintaining a temperature of +2°C to +8°C with suitable cold chain packing.

Q: What will be the expiry date of the kit from the date of supply?

A: One year from the date of production when stored unopened at +2°C to +8°C and protected from sunlight.

Q: What should be done for near/short expiry products?

A: Plan your order and consume.

Q: What pH do you recommend when using your culture media?

A: pH ranging from 7.25 to 7.50.

Q: Who will take responsibility for delivering the goods on time?

A: Shivani team.

Q: How can one check if the cold chain is maintained during transit?

A: A USB data logger can be provided with the product, shipped in cold chain cargo made with appropriate packing.

Q: If any variation is observed in temperature during transit, can the kit/media still be used?

A: Temperature and related time periods have a cumulative effect on media potential.

Q: Can we get some special training/instructions to use this media?

A: Yes, support can be provided.

Q: Is there any visual method to check if the media is, okay?

A: All media should be checked with the naked eye for any suspended particles and color changes as per the pH range. Check the temperature with a thermometer.

Q: What if the expiration date of the media falls in the middle of the cycle? Can it still be used?

A: Discard it.

Q: Is it okay to use media if it is frozen?

A: No.

Q: What is Jacket Warmer?

A: Jacket Warmer is a test tube warmer designed to prevent a drop in the temperature of the follicular fluid inside the test tube. Without it, the temperature can decrease nearly three times faster in a bare test tube.

Q: How many tubes does it hold?

A: It can hold up to 12 tubes.

Q: What metal are the jackets made of, and what is their thermal conductivity?

A: The jackets are made from a special Aluminium Alloy HE 30, with a thermal conductivity of 2.37 watts/cm.

Q: Can the unit and jackets be sterilized?

A: Yes, the unit can be externally cleaned using sterile water, 70% isopropyl alcohol, Fertisafe, or Oosafe. The jackets can be sterilized by autoclaving.

Q: What type of test tubes can it hold?

A: It is compatible with 14ml round bottom tubes.

Q: How do I switch on the Jacket Warmer?

A: Plug in the power cord into the power supply and switch it “ON” The display will show an orange power button. Long-press the button for 2 seconds, and the warmer will turn on.

Q: What is the efficiency of the jackets in maintaining the temperature of the follicular fluid? Why should I use Jacket Warmer?

A: Jacket Warmer allows you to transport tubes of follicular fluid from the operating theater to the workstation without a significant drop in temperature. The temperature of the test tube containing follicular fluid does not decrease by more than 0.15°C in 100 seconds when using the jacket warmer. In contrast, the temperature of follicular fluid in an unprotected test tube drops by nearly 0.75°C in the same time.

Q: What sort of voice notifications does the device provide?

A: Once the temperature of 37°C is reached, the device will provide a voice notification. Additionally, important error messages are conveyed through voice notifications.

Q: What is the purpose of the digital temperature bar indicator?

A: The mood bar indicator, with green and red colours, indicates stability and the rate of temperature rise from a distance. Initially, after startup, the moving red bar indicates that the Jacket Warmer is still reaching the set temperature. Once the temperature is achieved, the colour changes to green, with its movement gradually slowing down and ultimately stopping.

Q: What indications are shown on the display?

A: The display shows the Power Switch, Up and Down Keys, Digital Temperature Display, and the bar indicator.

Q: How do I change the set temperature?

A: Use the ^ and v keys to adjust the set temperature by pressing the ^ ^ v v keys.

Q: What is the price and quantity?

A: Price and quantity will be displayed and discussed.

Q: Is it possible to customize?

A: Currently, we offer our standard kit. If you require more than 60 Profert Kits, we can customize them for you.

Q: Do all the procedure items come with the kit?

A: Yes. For example, the ICSI kit includes Semen Preparation, Ovum Pickup, Denudation, ICSI, Culture, and ET components.

Q: How many Semen Collection Jars are included?

A: There are 3 units, which are used for collecting semen and extra follicular fluid, especially in PCOD patients.

Q: How is Profert Kit beneficial for patients?

A: If purchased from a pharmacy, patients can get reimbursement for medical bills from the company.

Q: How is it cost-effective for the IVF Centre?

A: Profert Kit is precise, minimizing misses and wastage. The Profert ICSI kit provides extra quantities of all disposables. By purchasing one additional unit of RI Holding from the stockist, you can perform two ICSI procedures at the cost of one ICSI kit.

Q: Where is the manufacturing and packing done?

A: Shivani Scientific has established a new medical device manufacturing facility, the first of its kind in the world of Assisted Reproduction, for manufacturing Profert ART kits. This facility is designed in accordance with Indian CDSCO (FDA) and international standards.

Q: Is one kit enough for one cycle?

A: Yes, in fact, we have provided extra quantities as a buffer.

Q: What is the kit’s expiry date?

A: The kit has an expiry date of 1-2 years. We mention the nearest product expiry date.

Q: What if I don’t want to use the RI injection and holding pipette?

A: No issues. You can opt for our Profert IVF kit. We can customize it if your order is for 60 units or more.

Q: Are only Falcon products available?

A: No, Falcon products don’t come in individual packaging (20s pack). However, the ICSI dish is from Falcon, and we can provide it individually packaged or a Nunc ICSI dish. We offer Nunc’s IVF grade dishes, which are tested for MEA, LAL tests for endotoxin, and the polystyrene material is tested for AME. It meets class VI material standards.

Q: Can the Profert kit be sold directly to patients?

A: Yes, patients can purchase it from the pharmacy with their prescription, allowing the pharmacy to claim an 18% GST refund.

Q: How to store the big box when our drawers are not that large?

A: The Profert outer box should be kept outside the lab. The inner tray should be removed as per the procedure.

Q: How efficient are the products in the kit?

A: All the products are from international brands, manufactured by reputable companies in the field of IVF. We do not break the seals of any product. If any product is compromised, we will replace it with a fresh one. Always ensure you have extra Holding at your disposal.

Q: Why should our center choose the Profert Kit?

A; Opting for the Profert Kit makes it easy to maintain stock according to our requirements. There are no chances of missing any items as everything is included in a single pack, saving time and reducing the likelihood of errors.

Q: Do we need to keep extra stock with the Profert Kit?

A: No, there’s no need to maintain extra stock because the Profert Kit already provides additional quantities in the pack.

Q: How does the Profert Kit reduce the chances of mishandling?

A: The Profert Kit minimizes the chances of mishandling since all the components are conveniently packed together, ensuring that items are handled correctly and with care.

Q: How does choosing the Profert Kit help reduce the risk of pilferage?

A: Opting for the Profert Kit reduces the chance of pilferage as it offers a complete package, making it less enticing for unauthorized removal of individual items.

Q: How does the Profert Kit help in reducing transportation costs?

A: The Profert Kit helps in reducing transportation costs because it is a comprehensive package with all the necessary components, eliminating the need for multiple shipments and saving on transport expenses.

Q: Can the Profert Kit be billed to and from the pharmacy, and can GST be claimed?

A: Yes, the Profert Kit can be billed to and from the pharmacy, and GST can be claimed, making it a cost-effective choice for your center.

Q: Why is temperature regulation in a centrifuge necessary if centrifugation lasts only for 10-20 minutes?

A: The generation of ROS, sperm motility, and their longevity on incubation depend on the temperature and its fluctuations. Hence, maintaining a stable temperature throughout the process is necessary.

Q: In mammals, sperm production occurs outside the body, and it is said to be around 34°C. Why is 37°C required? What are the sizes of tubes?

A: The Spermfuge has a temperature range from RT (around 21° - 42°C), and for simplicity, it is set at 37°C, but you can keep it around 34° - 35°C as needed.

Q: Why did the WHO manual not mention centrifugation when everyone has been using it for the last 10 years or more?

A: This is an inappropriate question. The WHO has recently established the SIG for stem cell research, although the work has been ongoing for more than 20 years. The WHO does not provide directions for every instrument and its use in labs. Furthermore, the WHO manual has always included sperm preparation methods in the appendix, which were considered appropriate at the time of publication.

Q: Why is g-Force mentioned by most media companies/publications instead of RPM?

A: It’s a matter of standardization. RPM (Revolutions Per Minute) and “g” Force are two different measures. RPM is the speed of rotation, whereas “g” Force measures the gravitational force acting on the sample. “g” Force is more specific and can be calculated using the formula “g” = 0.00001118 x radius x (rpm)^2. This measurement provides a comprehensive force acting on the sample.

Q: Which types of tubes can be used for centrifugation?

A: The choice of tubes depends on the user and the sample parameters. The key consideration is that the tubes should withstand a “g” force of about 1000xg and be sterile and disposable.

Q: What are the sizes of tubes that can be used?

A: One can use Falcon 6 ml, 14 ml, and 15 ml tubes.

Q: Why is a swing-out rotor head preferred over an angular rotor head?

A: The preference for a swing-out rotor head is related to the way the pellet is formed. In swing-out rotor centrifuges, the pellet is at the center, at the bottom of the tube, making it easier to withdraw the supernatant without disturbing the pellet. Additionally, the longer distance of travel in swing-out rotors can lead to better centrifugation in density gradient separation.

Q: Is it necessary to change the rotor head?

A: No, you only need to use an adapter when using 6 ml tubes.

Q: How many patient's samples can be processed simultaneously in one centrifuge chamber?

A: In the Spermfuge, a maximum of 8 patient’s samples can be processed at a time.

Q: If the tubes break during centrifugation when processing 8 tubes, what will happen?

A: You will lose the samples and the sterility of the samples. Contamination may occur when changing the tubes and recovering them from the bucket. The cause of tube breakage should be investigated and corrected for future use.

Q: In a non-heated centrifuge, does the temperature drop or increase during centrifugation?

A: Technically, the temperature drops, but even if it rises, it will be marginal and primarily due to the friction from the motor’s rotation. The extent of temperature change depends on factors like time, RPM, and ”g” Force, which should be assessed through experiments.

Q: Is there any requirement to change the “g” Force/RPM for swim-up and density gradient techniques?

A: Yes, for swim-up, lower “g” Force/RPM is sufficient because the sample is near normozoospermia. In density gradient, higher “g” Force/RPM is used to concentrate sperm at the bottom of the tube due to the layered colloidal suspension.

Q: Is there a risk of cross-contamination during centrifugation when processing different patient samples simultaneously?

A: No, if the user follows proper aseptic procedures, uses good standard disposables, and complies with the established norms of the procedure. Spermfuge provides sealed buckets as an additional measure to prevent possible issues.

Q: Why does the rotor rotate when we have not started the run yet and after the end of the cycle?

A: The program helps maintain temperature by rotating the rotor, which acts as a blower for temperature uniformity.

Q: What is the temperature range?

A: The temperature can be set from 2°C above room temperature to 40°C.

Q: How long does it take to reach 37°C initially?

A: It takes about 30 minutes to achieve the desired temperature after starting.

Q: What is the effect of temperature on sperm count?

A: Temperature can improve the recovery of actively motile sperm from the original unwashed sample, especially if the original sample has a good number of total motile sperm count.

Q: What is the optimal temperature required?

A: The optimum temperature needed for sperm activation is 34°C.

Q: What is capacitation and when/how does it happen?

A: Capacitation is the process by which the sperm’s inner and outer plasma membranes fuse, preparing the sperm for fertilization. It occurs as the sperm swims up in the genital tract, against the current of cervical mucus and uterine fluid, from the vagina to the fimbriae.

Q: At what different temperatures are sperm samples exposed from collection room to IUI transfer?

A: Sperm samples are exposed to temperatures ranging from 34°C in the testis to room temperature (RT) in the collection room (1st step), RT during transportation, RT/37°C upon receiving (2nd step), RT/37°C to centrifugation temperature (3rd step), centrifugation temperature (37°C/rarely RT - 4th step), and incubation temperature/RT to IUI transfer at RT (5th step).

Q: What is the recommended storage area for semen samples before and after centrifugation?

A: There is no specific recommendation, but the present WHO manual suggests that liquefaction should occur within one hour at 37°C. An incubator at 37°C or a warming block may be suitable storage options.

Q: What is the average success rate in IUI for the swim-up method and density gradient method?

A: Regardless of the preparation method, the average pregnancy rate for IUI is around 10-15% per cycle. In terms of yield, density gradient has a slight edge over the swim-up method when dealing with subnormal samples.

Q: What are the advantages of using washed samples in Spermfuge?

A: The use of the Spermfuge results in a higher ”Sperm Yield” which means an increase in the yield of activated, progressively motile, capacitated, and functionally active spermatozoa.

Q: Is it advantageous in oligozoospermia samples as well?

A: Yes, it is advantageous because it improves both the quality and quantity of recovered sperm, and ideal morphology plays a vital role in successful fertilization.

Q: What will be the difference in results?

A: The recovery of sperm will be better, both qualitatively and quantitatively. However, the outcome cannot be solely judged by sperm performance, as other factors also influence successful fertilization.

Q: While using the Spermfuge, will there be a rise in the pregnancy rate, and if so, by how much and why?

A: There is no documented evidence regarding the impact of the Spermfuge on the pregnancy rate, so a study is recommended to investigate this.

Q: Are there any recurring expenses while using the Spermfuge?

A: There are no specific recurring expenses, apart from the increase in the electricity bill by approximately one unit per day. Occasionally, there may be service-related issues such as the replacement of PCB or parts due to regular wear and tear associated with any machine with moving parts.