OvarStore
The GM501 OvarStore is used for transport, cryopreservation and in vitro culture of human ovarian tissue.
It is to be applied for patients who want to make sure that in spite of an upcoming chemotherapy / radiotherapy measure, they will be able to fulfill their desire to have children as well as for therapy independently from baby-planes. For these two reasons, they have ovarian tissue extracted prior to their therapy. The tissue is treated using the media and can be returned into the patient’s body at a later date without overloading this tissue by the therapy.
Five different solutions of GM501 OvarStore media are using for a cooled transport of uman ovarian fragments after operation-(GM501 OvarStore Transport), preparation of strips from these fragnats (GM501 OvarStore Dissection), freezing (GM501 OvarStore Cryo), thawing (GM501 OvarStore Thaw) and long-term in vitro culture (GM501 Cult).
Description of Kit content.
(Each kit is sufficient for one application)
- 1 unit GM501 OvarStore Transport (medium for the transport at low temperature); Hypo Thermosol; 50 ml.
- 1 unit GM501 OvarStore Dissection (medium for preparation of ovarian cortex in form of strips); Leibowitz L-15, HSA, Gentamycine; 50ml.
- 1 unit GM501 OvarStore Cryo (cryo medium); Ethylen glycole, DMSO, DSS, Gentamycine; 50 ml.
- 1 unit GM501 OvarStore Thaw (thawing medium); Sucrose, HSA, Gentamycine; 30 ml.
- 1 unit GM501 Cult (medium for in vitro culture); AIM V; 50 ml.
Material and equipment required (not provided with the Kit).
- 1 sterile flow bench,
- 3 sterile Petri dishes (100 mm),
- 1 sterile urine sample container,
- 1 sterile scalpel,
- 15 ml sterile syringe,
- 170 mm long sterile needle,
- 2 sterile forceps (anatomic forceps 25 cm, Tweezers with sharp tips 12 cm), sterile gloves, cryo-packing with tissue straws, high security straws or suitable cryo-tubes.
Product specifications and quality control:
- The media are manufactured according to ISO 9001 and ISO 13485 standards.
- All raw materials are of highest available purity (European Pharmacopoeia and/or USP standard) if applicable.
- A certificate of analysis is available for each batch upon request from our website with respective Lot number.
- The media are manufactured and tested according to the following specifications:
GM501 OvarStore Transport | Sterility | SAL 10-3 (Sterility Assurance Level) |
GM501 OvarStore Dissection | Sterility | SAL 10-3 (Sterility Assurance Level) |
GM501 OvarStore Cryo | pH (at 37°C, 6% CO2) | 7,20 - 7,60 |
Sterility | SAL10-3 (Sterility Assurance Level) | |
Endotoxins (EU/ml) | < 0,25 |
GM501 OvarStore Thawing | pH (at 37°C, 6% CO2) | 7,20 - 7,60 |
| Sterility | SAL10-3 (Sterility Assurance Level) |
| Endotoxins (EU/ml) | < 0,25 |
Osmolality (mOsm/kg) | 850 - 900 |
GM501 Cult + G | pH (at 37°C, 6% CO2) | 7,20 - 7,45 |
| Sterility | SAL10-3 (Sterility Assurance Level) |
| Endotoxins (EU/ml) | < 0,25 |
Osmolality (mOsm/kg) | 270 - 290 | |
MEA (Blastocysts after 96 h in %) | ≥ 80 after 30 min of exposure (zygote stage) |
Instructions for use.
5.1. In general.
The distance between the OP and the biological laboratory decides between the application of GM501 OvarStore Transport or GM501 OvarStore Dissection.
Option A: If the transport time lies between 25 minutes and maximum 26 hours, the tissue should be handled in GM501 OvarStore Transport. The ideal transport temperature for GM501 OvarStore Transport is 2°C to 8°C.
Option B: If the transport time lies below 25 minutes, it is recommended to handle the tissue in GM501 OvarStore Dissection. The ideal transport temperature for GM501 OvarStore Dissection is between room temperature and 37°C.
5.2. Preparation for extraction of ovarian tissue.
The extraction of ovarian tissue is possible in any phase of the cycle. The attending doctor decides on the preparations to be done for the extraction.
1 to 2 days before extraction of ovarian tissue:
Procure and store 25 ml – 50 ml GM501 OvarStore Transport at 2°C - 8°C in the operation area.
1 day before extraction of ovarian tissue:
Transport time “Option A” (see In general) - procure 50 ml GM501 OvarStore Transport and GM501 OvarStore Dissection in the fridge at 2°C - 8°C.
Transport time “Option B” (see In general) – procure 25 ml GM501 OvarStore Dissection (for the transport) and 50 ml the same GM501 OvarStore Dissection (for preparation of strips) in the fridge.
Day of ovarian tissue extraction:
Take procured GM501 OvarStore Dissection out of the fridge and let them warm to room temperature (maximum 37°C).
Prepare sterile Flow Bench with 3 sterile Petri dishes (100 mm) 1 sterile scalpel, 1 sterile urine sample container, 2 sterile forceps and sterile gloves.
Open Cryo-Packing and mark the single components (tissue straws, high-security-straws, cryo tubes) with the details of the patient and procure on the Flow Bench.
5.3. Ovarian tissue extraction.
The extraction of ovarian tissue is to be solely effected by a qualified specialist.
Put extracted tissue in a prepared 50 ml tube with medium (Option “A”: 25 ml – 50 ml GM501 OvarStore Transport; Option “B”: 25 ml – 50 ml GM501 OvarStore Dissection).
Transport of tissue tubes to biological laboratory.
5.4. Preparation of strips and freezing.
Dissection of the ovary medulla (stroma) from the cortical part of the ovarian tissue using scalpel and forceps.
Preparation of strips with supposition “one strip for one tube”.
Induce saturation of the ovarian tissue with cryoprotectants over 30 min until max. 1 hour at room temperature in the sterile urine sample container (with 30 ml of GM501 OvarStore Cryo).
Fill the prepared cryo-packing (tissue straws, high-security-straws or cryo tubes) with GM501 OvarStore Cryo using a syringe with long needle.
After equilibration, transfer the tissue strips into the cryo-packing using sterile tweezers, close then these cryo-packing and place it over 10 min into icewater, then position cryo-packing in the rack of the freezer and freeze as described above:
- Stage 1: from room temperature to 0°C, at a rate -2°C/min;
- Stage 2: from 0°C to -7°C , at a rate -1°C/min;
- Seeding (manual or automatic): at -7°C with subsequent 10-min holding at -7°C;
- Stage 3: from -7°C to -35°C, at a rate -0.3°C/minute;
- Stage 4: after achieving of -35°C, the cryo-packing with ovarian tissue immerse into fluid nitrogen and locate it for long-term storage in cryobank
5.5. Thawing.
The thawing can be optionally realized as per one of the following methods:
Method 1 (routine):
Hold cryo-packing with the tissue into a 1000 ml 40°C water bath until only a small ice apex remains in the packing.
Method 2 (recommended method):
Hold cryo-packing with the tissue into a 1000 ml 100 °C water bath for about 20 sec using a magnetic stirrer, until only a small ice apex remains in the packing.
Precautions and warnings:
- The media contains human albumin solution (HAS), which is produced from blood of donors of certified US blood banks according the guidelines of FDA. Source materials from which this product was delivered was found negative when tested for antibodies to HIV, Hbc, HCV and HTLV I/II and non-reactive for HbsAg, HCV RNA and HIV-1 RNA and syphilis. No known test method can offer assurance that products delivered from human blood will not transmit infectious agents. Therefore, handle all specimens as if capable of transmitting HIV or hepatitis.
- Always wear protective clothing when handling specimens.
- Always work under strict hygienic conditions (ISO5 environment) to avoid possible contamination.
- Do not use the product if bottle, seal of the container or package is opened or defect when the product is delivered.
- Do not use the product if it becomes cloudy, or shows any evidence of microbial contamination.
- Only for the intended use.
Storage instructions and stability:
- Shelf life from is 6 month from time of manufacture.
- Store between 2-8°C
- Do not freeze before use.
- Keep away from (sun) light.
- After opening the container do not use the product longer than 7 days.
- Do not use after expiration date.
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