SEQUENTIAL CULTURE MEDIA SYSTEM

Transcription

1 SEQUENTIAL CULTURE MEDIA SYSTEM

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3 Gamete solutions... 7 Fertilization solutions...15 Cleavage solutions...21 Blastocyst solutions...27 STIC Media Stopper Removal Tool...35 Complete list of order numbers...36

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5 Nurture gametes and embryos with the nutrients they need. Our culture system mimics the delicate and dynamic environment of the female reproductive tract by providing nutrients to meet the shifting metabolic requirements of gametes and embryos.

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7 GAMETE Gamete collection and preparation might be the most stressful process in IVF, and the environmental disruption that occurs can significantly impair gamete viability. These gamete solutions meet the metabolic requirements of the oocyte and help to maintain oocyte homeostasis so that subsequent steps in IVF can succeed. 7

8 SYDNEY IVF GAMETE BUFFER GAMETE Sydney IVF Gamete Buffer is used to physically wash and store gametes in preparation for the fertilization step in the IVF process. Designed to be used in atmospheric air conditions, not an enriched CO 2 environment HEPES buffered Designed to prepare oocytes and maintain a stable environment during washing of cumulus-enclosed oocytes. Designed to prepare sperm for swim-up, density gradient, and diluent procedures Can be used during ICSI USAGE Sydney IVF Gamete Buffer is designed for gamete washing, swim-up procedures, and use as a diluent in density gradient and sperm-thawing procedures. It can also be used for ICSI when a HEPES-buffered environment is required. After ovum aspiration, Sydney IVF Gamete Buffer is used to wash the cumulus-oocyte complex before it is transferred into Sydney IVF Fertilization Medium. The nonessential amino acids prevent the depletion of the oocyte s internal pool of amino acids. Order Reference Volume Number Part Number ml G46320 K-SIGB-20-AA 20 G46318 K-SIGB-50-AA 50 G46317 K-SIGB-100-AA 100 RELATED PRODUCTS Sydney IVF Follicle Flush Buffer Sydney IVF Spermient Sydney IVF Sperm Gradient Kit Cook Flexipet Pipettes CONSTITUENTS Calcium lactate D-glucose Gentamicin Glutamine, stabilized Glycine HEPES Human serum albumin (HSA)* L-alanine L-asparagine L-aspartic acid L-glutamic acid L-proline L-serine Magnesium sulphate Potassium chloride Potassium phosphate Purified water Sodium bicarbonate Sodium chloride Sodium pyruvate Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml HSSA: 90% of control at 24 hours We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 8

9 SYDNEY IVF SPERM MEDIUM Sydney IVF Sperm Medium is intended for use during in vitro fertilization procedures to process sperm. Used for sperm preparation and storage Recommended for swim-up and sperm washing in 6% CO 2 USAGE Sydney IVF Sperm Medium is designed for use with the swim-up technique to separate motile populations of sperm. Intrauterine insemination can be performed in this medium, or sperm can be resuspended in Sydney IVF Fertilization Medium prior to the insemination of oocytes in vitro. The product should be equilibrated in 6% CO 2 before use. Order Reference Volume Number Part Number ml G46316 K-SISM-20-AA 20 G46315 K-SISM-50-AA 50 G46314 K-SISM-100-AA 100 RELATED PRODUCTS Sydney IVF Gamete Buffer Sydney IVF Sperm Gradient Kit Sydney IVF Sperm Cryopreservation Buffer Sydney IVF Fertilization Medium IUI catheters CONSTITUENTS Calcium lactate D-glucose Gentamicin Glutamine, stabilized Glycine Human serum albumin (HSA)* Magnesium sulphate Potassium chloride Potassium phosphate Purified water Sodium bicarbonate Sodium chloride Sodium pyruvate Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml GAMETE We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 9

10 SYDNEY IVF SPERM GRADIENT KIT GAMETE Sydney IVF Sperm Gradient is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma. Sold as a convenient two-part kit for separating motile sperm Contains silane-coated silica Includes one vial of 40% solution and one vial of 80% solution USAGE Sydney IVF Sperm Gradient was designed for use in sperm preparation via density-gradient separation. The gradients are prepared by adding 1.5 ml of 40% solution underlaid with 1.5 ml of 80% solution in a conical-bottom test tube. The liquefied semen is then overlaid onto the gradients. The test tube is centrifuged, and the resultant pellet is aspirated and washed in Sydney IVF Gamete Buffer. The final pellet is resuspended in either Sydney IVF Sperm Medium or Sydney IVF Fertilization Medium. Order Reference Volume Number Part Number ml G46313 K-SISG-20-AA 20 (x2) G46312 K-SISG-50-AA 50 (x2) RELATED PRODUCTS Sydney IVF Gamete Buffer Sydney IVF Sperm Medium Sydney IVF Sperm Cryopreservation Buffer Sydney IVF Fertilization Medium CONSTITUENTS Calcium lactate D-glucose Gentamicin Glutamine, stabilized Glycine HEPES Human serum albumin (HSA)* Magnesium sulphate Potassium chloride Potassium phosphate Purified water Silane-coated silica particles Sodium bicarbonate Sodium chloride Sodium pyruvate Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 10

11 SYDNEY IVF SPERMIENT Sydney IVF Spermient is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma. Sold at a 100% concentration of silane-coated-silica based stock solution to enable customization of sperm density separation Can be diluted with Sydney IVF Gamete Buffer to any required concentration USAGE Sydney IVF Spermient is a 100% stock solution that should be diluted with Sydney IVF Gamete Buffer to the density required for use (for example, 80% and 40%).* A one- or two-layer gradient is then prepared in a conical-bottom test tube. The liquefied semen is overlaid on the gradient. The tube is centrifuged, and the resultant pellet is aspirated and washed in Sydney IVF Gamete Buffer. The final pellet is resuspended in either Sydney IVF Sperm Medium or Sydney IVF Fertilization Medium. Order Reference Volume Number Part Number ml G46311 K-SISP-20-AA 20 G46310 K-SISP-100-AA 100 RELATED PRODUCTS Sydney IVF Gamete Buffer Sydney IVF Sperm Medium Sydney IVF Sperm Cryopreservation Buffer Sydney IVF Fertilization Medium CONSTITUENTS Calcium lactate D-glucose Gentamicin Glutamine, stabilized Glycine HEPES Human serum albumin (HSA)** Magnesium sulphate Potassium chloride Potassium phosphate Purified water Silane-coated silica particles Sodium bicarbonate Sodium chloride Sodium pyruvate Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml GAMETE We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *Use of this medium at dilutions below 40% and above 80% has not been evaluated and therefore is not recommended. **We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 11

12 SYDNEY IVF SPERM CRYOPRESERVATION BUFFER GAMETE Sydney IVF Sperm Cryopreservation Buffer is intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing. HEPES buffered Contains glycerol as a cryoprotectant Suitable for microsurgical epididymal sperm aspiration (MESA) and testicular sperm aspiration (TESA) samples USAGE Sydney IVF Sperm Cryopreservation Buffer is used for the freezing of washed spermatozoa. It is a HEPES-buffered solution that contains glycerol as a cryoprotectant. Order Reference Volume Number Part Number ml G46309 K-SISC-20-AA 20 RELATED PRODUCTS Sydney IVF Gamete Buffer Sydney IVF Sperm Medium Sydney IVF Sperm Gradient Kit IUI catheters CONSTITUENTS Calcium lactate D-glucose HEPES Gentamicin Glycerol Glycine Human serum albumin (HSA)* Magnesium sulphate Potassium chloride Purified water Sodium bicarbonate Sodium chloride Sodium phosphate Sucrose RELEASE SPECIFICATIONS ph (in air): Osmolality: 1,190-1,210 mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml HSSA: 90% of control at 24 hours We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 12

13 SYDNEY IVF FOLLICLE FLUSH BUFFER Sydney IVF Follicle Flush Buffer is intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection. HEPES buffered Suitable for flushing needles and lines Contains nonessential amino acids Protein free USAGE Sydney IVF Follicle Flush Buffer contains nonessential amino acids. This solution is HEPES buffered so that it maintains ph at 37 C without the use of a CO 2 incubator. Order Reference Volume Number Part Number ml G46308 K-SIFB-100-AA 100 RELATED PRODUCTS Sydney IVF Gamete Buffer Aspiration needles Cook Vacuum Pump Test Tube Heater CONSTITUENTS Calcium lactate D-glucose Gentamicin Glutamine, stabilized Glycine HEPES L-alanine L-asparagine L-aspartic acid L-glutamic acid L-proline L-serine Magnesium sulphate Potassium chloride Potassium phosphate Purified water Sodium bicarbonate Sodium chloride Sodium pyruvate Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered GAMETE We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 13

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15 Achieving a high fertilization rate increases the potential success of any treatment cycle, and successful fertilization whether ICSI or insemination depends in part on the fertilization media. These formulations are made with carefully selected ingredients and stringent quality-control procedures. 15

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17 SYDNEY IVF CULTURE OIL Sydney IVF Culture Oil is intended to be used as an oil overlay for culture of gametes, zygotes, or embryos in assisted reproductive technology (ART) and micromanipulation procedures. Specifically designed for human IVF Extensively tested to ensure quality Tested for peroxide value Tested for peroxide toxicity with a specially designed MEA Packaged to reduce headspace and protect the product from light USAGE Sydney IVF Culture Oil protects gametes and embryos during culture and IVF procedures by creating a barrier between the embryo culture medium and the atmosphere. This barrier helps to prevent evaporation and minimizes fluctuations in ph and osmolality. Order Reference Volume Number Part Number ml G46319 K-SICO-50-2-AA 50 (x2) RELATED PRODUCTS Sydney IVF Fertilization Medium Sydney IVF Cleavage Medium Sydney IVF Blastocyst Medium Cook Flexipet Pipettes CONSTITUENTS Mineral oil RELEASE SPECIFICATIONS 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Peroxide toxicity MEA: Two-cell MEA 80% of control expanded to blastocysts at 72 hours Peroxide value assay: < 0.01 meq/kg Endotoxins: < 0.40 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered GAMETE We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 17

18 SYDNEY IVF MEDIUM GAMETE Sydney IVF Fertilization Medium is intended for use during in vitro procedures for insemination and incubation of oocytes. Bicarbonate buffered Can be used for both short and long insemination protocols Provides a glucose-rich environment for efficient cumulus-oocyte complex and sperm cell metabolism Includes antioxidants and nonessential amino acids USAGE After the cumulus-oocyte complex has been washed, it is placed in Sydney IVF Fertilization Medium, where insemination occurs. The oocyte can remain in this medium for hours. The fertilized oocytes are checked for pronuclei and then transferred into Sydney IVF Cleavage Medium. This is the first step in the Cook Medical sequential system. Order Reference Volume Number Part Number ml G46307 K-SIFM-20-AA 20 G46306 K-SIFM-50-AA 50 G46305 K-SIFM-100-AA 100 RELATED PRODUCTS Sydney IVF Gamete Buffer Sydney IVF Sperm Medium Sydney IVF Cleavage Medium Cook Flexipet Pipettes CONSTITUENTS Calcium lactate Calcium pantothenate D-glucose EDTA Gentamicin Glutamine, stabilized Glycine Human serum albumin (HSA)* L-alanine L-asparagine L-aspartic acid L-glutamic acid L-proline L-serine Magnesium chloride Magnesium sulphate Potassium chloride Potassium phosphate Purified water Sodium bicarbonate Sodium chloride Sodium pyruvate Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 18

19 SYDNEY IVF PVP Sydney IVF PVP is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures. Bicarbonate buffered Contains 10% polyvinylpyrrolidone (PVP) USAGE Sydney IVF PVP is used to reduce the motility of sperm so that it is easier to isolate and capture with an ICSI pipette. The product should be equilibrated in 6% CO 2 prior to use. Order Reference Volume Number Part Number μl G46303 K-SIPV AA 200 (x5) RELATED PRODUCTS Sydney IVF Gamete Buffer Sydney IVF Cleavage Medium Cook Flexipet Pipettes Micromanipulation pipettes CONSTITUENTS Calcium lactate D-glucose Gentamicin Glutamine, stabilized Glycine Human serum albumin (HSA)* Magnesium sulphate Potassium chloride Potassium phosphate Purified water PVP (MW 360,000) Sodium bicarbonate Sodium chloride Sodium pyruvate Taurine RELEASE SPECIFICATIONS 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml GAMETE We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 19

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21 The embryo's metabolic needs must be met for successful cleavage to occur and for the embryo to be viable for transfer, cryopreservation, and further culturing. These media formulations meet those needs by delivering necessary metabolites to the developing embryo. 21

22 SYDNEY IVF MEDIUM GAMETE Sydney IVF Cleavage Medium is intended for use during in vitro fertilization procedures for culture and transfer of cleavage-stage embryos. A bicarbonate-buffered medium specifically designed for early cleavage-stage development Low in glucose and high in pyruvate to support early cleavage-stage development Recommended for ICSI procedures to support oocytes when cumulus cell metabolism and sperm cell movement are no longer critical USAGE After normally fertilized oocytes are identified, they are transferred into Sydney IVF Cleavage Medium for culture from day 1 to day 3 (up to the eight-cell stage). Sydney IVF Cleavage Medium is formulated to provide early embryos with the necessary metabolic substrates for development. This is the second step in the Cook Medical sequential system. Order Reference Volume Number Part Number ml G46302 K-SICM-20-AA 20 G46301 K-SICM-50-AA 50 G46300 K-SICM-100-AA 100 RELATED PRODUCTS Micromanipulation pipettes Sydney IVF Cryopreservation Kit Sydney IVF Thawing Kit CONSTITUENTS Calcium lactate Calcium pantothenate D-glucose EDTA Gentamicin Glutamine, stabilized Glycine Human serum albumin (HSA)* L-alanine L-arginine L-asparagine L-aspartic acid L-cystine L-glutamic acid L-histidine L-isoleucine L-leucine L-lysine L-methionine L-phenylalanine L-proline L-serine L-threonine L-tryptophan L-tyrosine L-valine Magnesium chloride Magnesium sulphate Potassium chloride Potassium phosphate Purified water Sodium bicarbonate Sodium chloride Sodium pyruvate Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 22

23 SYDNEY IVF EMBRYO BIOPSY MEDIUM Sydney IVF Embryo Biopsy Medium is intended for use in assisted reproduction technologies to facilitate the aspiration of blastomeres for preimplantation genetic diagnosis. Calcium and magnesium-free medium USAGE Embryos are placed in this medium for approximately five minutes (a minimum of 1 minute to a maximum of 10 minutes) to break down gap junctions between blastomeres. One or two blastomeres are removed for genetic analysis, and the embryo is then returned to the Sydney IVF Cleavage Medium or Sydney IVF Blastocyst Medium for further culturing. The product should be equilibrated in 6% CO 2 prior to use. Order Reference Volume Number Part Number ml G46299 K-SIEB-20-AA 20 RELATED PRODUCTS Sydney IVF Cleavage Medium Sydney IVF Blastocyst Medium Cook Flexipet Pipettes Cook Blastomere Aspiration Pipettes CONSTITUENTS EDTA Gentamicin Glutamine, stabilized Glycine Human serum albumin (HSA)* L-alanine L-asparagine L-aspartic acid L-glutamic acid L-proline L-serine Potassium chloride Potassium phosphate Purified water Sodium bicarbonate Sodium chloride Sodium pyruvate Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml GAMETE We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 23

24 SYDNEY IVF CRYOPRESERVATION KIT GAMETE The Sydney IVF Cryopreservation Kit is intended for use during in vitro fertilization procedures for cryopreservation of 1-cell to 8-cell embryos. HEPES buffered Sold as a three-step kit Contains propanediol and sucrose as cryoprotectants Suitable for all stages from zygote to compacted morulae USAGE The Sydney IVF Cryopreservation Kit protects human cleavage-stage embryos from 2PN to 8-cell stage during dehydration and freezing. This HEPES-buffered kit contains propanediol and sucrose as cryoprotectants and is used in a three-step equilibration protocol. Order Reference Volume Number Part Number ml G46298 K-SICS-5000-AA 10 (x2) 20 (x1) RELATED PRODUCTS Sydney IVF Thawing Kit Sydney IVF Cleavage Medium Cook Flexipet Pipettes CONSTITUENTS Calcium lactate Calcium pantothenate D-glucose EDTA Gentamicin Glutamine, stabilized Glycine HEPES Human serum albumin (HSA)* L-alanine L-asparagine L-aspartic acid L-glutamic acid L-proline L-serine Magnesium chloride Magnesium sulphate Potassium chloride Potassium phosphate Propanediol Purified water Sodium bicarbonate Sodium chloride Sodium pyruvate Sucrose Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality of base solution: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 24

25 SYDNEY IVF THAWING KIT The Sydney IVF Thawing Kit is intended for use during in vitro fertilization procedures for thawing of 1-cell to 8-cell embryos. HEPES buffered Used in a four-step protocol Formulated to match the Sydney IVF Cryopreservation Kit and reduce embryo stress USAGE The Sydney IVF Thawing Kit is used to thaw earlystage embryos, from 2PN to morula, that have been cryopreserved by use of a slow-freeze technique. This kit has a four-step dilution protocol. Order Reference Volume Number Part Number ml G46297 K-SITS-5000-AA 10 (x4) RELATED PRODUCTS Sydney IVF Freezing Kit Sydney IVF Cleavage Medium Cook Flexipet Pipettes Sydney IVF Cryopreservation Kit CONSTITUENTS Calcium lactate Calcium pantothenate D-glucose EDTA Gentamicin Glutamine, stabilized Glycine HEPES Human serum albumin (HSA)* L-alanine L-asparagine L-aspartic acid L-glutamic acid L-proline L-serine Magnesium chloride Magnesium sulphate Potassium chloride Potassium phosphate Propanediol Purified water Sodium bicarbonate Sodium chloride Sodium pyruvate Sucrose Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality of base solution: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml GAMETE We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 25

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27 Cellular differentiation is crucial for successful IVF outcomes, and blastocyst formation is a key indicator for embryo transfer. These blastocyst media formulations supply the nutrients that are required to produce high-quality blastocysts and to support them through uterine transfer and cryopreservation. The vitrification and warming kits contain trehalose, ethylene glycol, and DMSO to remove and displace water, thereby reducing embryo exposure to cryoprotectants prior to vitrification. These flexible and convenient kits can be used with any registered closedvitrification device that has a cooling rate greater than -15,000 ºC per minute. 27

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29 SYDNEY IVF MEDIUM Sydney IVF Blastocyst Medium is intended for use during in vitro fertilization procedures for extended culture and transfer of embryos. Designed to provide the necessary nutrients to support blastulation, differentiation, and expansion Bicarbonate buffered Has a higher glucose concentration for blastocyst metabolism and energy production Includes essential and nonessential amino acids to support blastocyst development Ideal for use in a low-oxygen environment USAGE Once an embryo has reached day 3 (the eight-cell) stage, it is transferred into Sydney IVF Blastocyst Medium, which is metabolically balanced to support blastocyst development. This is the third and final step of the Cook Medical sequential system. Order Reference Volume Number Part Number ml G46296 K-SIBM-20-AA 20 G46295 K-SIBM-50-AA 50 RELATED PRODUCTS Embryo transfer catheters Sydney IVF Blastocyst Vitrification Kit Sydney IVF Blastocyst Warming Kit Sydney IVF Blastocyst Freezing Kit Sydney IVF Blastocyst Thawing Kit Cook Flexipet Pipettes CONSTITUENTS Calcium lactate Calcium pantothenate D-glucose Gentamicin Glutamine, stabilized Glycine Human serum albumin (HSA)* L-alanine L-arginine L-asparagine L-aspartic acid L-cystine L-glutamic acid L-histidine L-isoleucine L-leucine L-lysine L-methionine L-phenylalanine L-proline L-serine L-threonine L-tryptophan L-tyrosine L-valine Magnesium chloride Magnesium sulphate Potassium chloride Potassium phosphate Purified water Sodium bicarbonate Sodium chloride Sodium pyruvate Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml GAMETE We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 29

30 SYDNEY IVF CRYOPRESERVATION KIT GAMETE The Sydney IVF Blastocyst Cryopreservation Kit is intended for use in assisted reproduction technologies for cryopreservation of blastocysts. Facilitates long-term blastocyst storage HEPES buffered Contains glycerol and sucrose as cryprotectants Used in a three-step freezing process USAGE The Sydney IVF Blastocyst Cryopreservation Kit is used to protect human blastocysts during dehydration and freezing. This HEPES-buffered kit contains glycerol and sucrose as cryoprotectants and is used in a three-step equilibration protocol. Order Reference Volume Number Part Number ml G46294 K-SIBF-5000-AA 20 (x3) RELATED PRODUCTS Sydney IVF Blastocyst Medium Sydney IVF Blastocyst Thawing Kit Cook Flexipet Pipettes CONSTITUENTS Calcium lactate Calcium pantothenate D-glucose EDTA Gentamicin Glutamine, stabilized Glycerol Glycine HEPES Human serum albumin (HSA)* L-alanine L-asparagine L-aspartic acid L-glutamic acid L-proline L-serine Magnesium chloride Magnesium sulphate Potassium chloride Potassium phosphate Purified water Sodium bicarbonate Sodium chloride Sodium pyruvate Sucrose Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality of base solution: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 30

31 SYDNEY IVF THAWING KIT The Sydney IVF Blastocyst Thawing Kit is intended for use in assisted reproduction technologies for thawing of cryopreserved blastocysts. Used in a four-step thawing process HEPES buffered to protect cryopreserved blastocysts during thawing USAGE The Sydney IVF Blastocyst Thawing Kit is used to protect human blastocysts during thawing and rehydration. This kit has a four-step dilution protocol. Order Reference Volume Number Part Number ml G46293 K-SIBT-5000-AA 20 (x4) RELATED PRODUCTS Sydney IVF Blastocyst Medium Sydney IVF Blastocyst Cryopreservation Kit Cook Flexipet Pipettes Embryo transfer catheters CONSTITUENTS Calcium lactate Calcium pantothenate D-glucose EDTA Gentamicin Glutamine, stabilized Glycine HEPES Human serum albumin (HSA)* L-alanine L-asparagine L-aspartic acid L-glutamic acid L-proline L-serine Magnesium chloride Magnesium sulphate Potassium chloride Potassium phosphate Purified water Sodium bicarbonate Sodium chloride Sodium pyruvate Sucrose Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality of base solution: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml GAMETE We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 31

32 SYDNEY IVF VITRIFICATION KIT GAMETE The Sydney IVF Blastocyst Vitrification Kit is intended to be used for the vitrification of human blastocysts for ART procedures. This kit is designed for use with the Sydney IVF Blastocyst Warming Kit (K-SIBW-5000-AA). HEPES buffered Contains dimethyl sulfoxide (DMSO), ethylene glycol, and trehalose as cryoprotectants Used in a three-step vitrification process Not packaged ready to use the user must combine the solutions USAGE The Sydney IVF Blastocyst Vitrification Kit is used for the vitrification of blastocysts on day 5 or day 6. This HEPESbuffered kit contains DMSO, ethylene glycol, and trehalose as cryoprotectants and has a three-step equilibration protocol. Order Reference Volume Number Part Number ml G46292 K-SIBV-5000-AA 20 (x3) 10 (x1) RELATED PRODUCTS Sydney IVF Blastocyst Warming Kit Sydney IVF Blastocyst Medium Cook Flexipet Pipettes Embryo transfer catheters CONSTITUENTS Calcium lactate Calcium pantothenate D-glucose DMSO EDTA Ethylene glycol Gentamicin Glutamine, stabilized Glycine HEPES Human serum albumin (HSA)* L-alanine L-asparagine L-aspartic acid L-glutamic acid L-proline L-serine Magnesium chloride Magnesium sulphate Potassium chloride Potassium phosphate Purified water Sodium bicarbonate Sodium chloride Sodium pyruvate Trehalose Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality of base solution: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 32

33 SYDNEY IVF WARMING KIT The Sydney IVF Blastocyst Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using the Sydney IVF Blastocyst Vitrification Kit (K-SIBV-5000-AA) for ART procedures. HEPES buffered Contains trehalose Used in a three-step warming process USAGE The Sydney IVF Blastocyst Warming Kit is used for the warming of vitrified human blastocysts. This kit has a threestep warming and dilution protocol. Order Reference Volume Number Part Number ml G46291 K-SIBW-5000-AA 20 (x3) RELATED PRODUCTS Sydney IVF Blastocyst Vitrification Kit Sydney IVF Blastocyst Medium Cook Flexipet Pipettes Embryo transfer catheters CONSTITUENTS Calcium lactate Calcium pantothenate D-glucose EDTA Gentamicin Glutamine, stabilized Glycine HEPES Human serum albumin (HSA)* L-alanine L-asparagine L-aspartic acid L-glutamic acid L-proline L-serine Magnesium chloride Magnesium sulphate Potassium chloride Potassium phosphate Purified water Sodium bicarbonate Sodium chloride Sodium pyruvate Trehalose Taurine RELEASE SPECIFICATIONS ph (in air): Osmolality of base solution: mosm/kg 2-cell MEA: 80% of control expanded to blastocysts at 72 hours Endotoxins: < 0.4 EU/mL Shelf life: 20 weeks from date of manufacture Sterile: Aseptically filtered HSA assay: mg/ml GAMETE We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. *We take standard measures to prevent our medicinal human-blood and plasma products from causing infections. These steps include screening individual donations and plasma pools for specific markers of infection and inactivating and removing viruses during manufacture. Despite these safeguards, a possibility exists that medicinal blood or plasma products will transmit infective agents, including unknown or emerging agents or other pathogens. No reports of proven virus transmission have been linked to albumin that was manufactured by established processes to European Pharmacopoeia specifications. We strongly recommend that you record the patient name and lot number every time you use Cook Medical IVF media in a clinical procedure. 33

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35 The STIC Media Stopper Removal Tool is used to remove the plastic cap and metal ring from the culture media bottle and to remove and replace the stopper aseptically. STIC Media Stopper Removal Tool Order Number G51154 Reference Part Number K-STIC

36 COMPLETE LIST OF ORDER NUMBERS GAMETE Order Number Reference Part Number Vial Volume ml Order Number Reference Part Number Vial Volume ml Sydney IVF Gamete Buffer G46320 K-SIGB-20-AA 20 G46318 K-SIGB-50-AA 50 G46317 K-SIGB-100-AA 100 Sydney IVF Sperm Medium G46316 K-SISM-20-AA 20 G46315 K-SISM-50-AA 50 G46314 K-SISM-100-AA 100 Sydney IVF Sperm Gradient Kit G46313 K-SISG-20-AA 20 (x2) G46312 K-SISG-50-AA 50 (x2) Sydney IVF Culture Oil G46319 K-SICO-50-2-AA 50 (x2) Sydney IVF Fertilization Medium G46307 K-SIFM-20-AA 20 G46306 K-SIFM-50-AA 50 G46305 K-SIFM-100-AA 100 Order Number Sydney IVF PVP Reference Part Number Vial Volume μl G46303 K-SIPV AA 200 (x5) Sydney IVF Spermient G46311 K-SISP-20-AA 20 G46310 K-SISP-100-AA 100 Sydney IVF Sperm Cryopreservation Buffer G46309 K-SISC-20-AA 20 Sydney IVF Follicle Flush Buffer G46308 K-SIFB-100-AA 100 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. 36

37 Order Number Reference Part Number Vial Volume ml Order Number Reference Part Number Vial Volume ml Sydney IVF Cleavage Medium G46302 K-SICM-20-AA 20 G46301 K-SICM-50-AA 50 G46300 K-SICM-100-AA 100 Sydney IVF Embryo Biopsy Medium G46299 K-SIEB-20-AA 20 Sydney IVF Cryopreservation Kit G46298 K-SICS-5000-AA 20 (x1), 10 (x2) Sydney IVF Thawing Kit G46297 K-SITS-5000-AA 10 (x4) Sydney IVF Blastocyst Medium G46296 K-SIBM-20-AA 20 G46295 K-SIBM-50-AA 50 Sydney IVF Blastocyst Cryopreservation Kit G46294 K-SIBF-5000-AA 20 (x3) Sydney IVF Blastocyst Thawing Kit G46293 K-SIBT-5000-AA 20 (x4) Sydney IVF Blastocyst Vitrification Kit G46292 K-SIBV-5000-AA 20 (x3), 10 (x1) Sydney IVF Blastocyst Warming Kit G46291 K-SIBW-5000-AA 20 (x3) STIC Media Stopper Removal Tool Order Number G51154 Reference Part Number K-STIC-1000 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. 37

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40 MEDICAL COOK 05/2018 RH-D41365-EN-F