(86 days)
No
The device description and performance studies focus on the chemical composition and biological efficacy of cryopreservation media, with no mention of AI or ML technologies.
No
This device is for vitrification and warming of oocytes and embryos, which is a process for preservation rather than treatment of a disease or condition in a patient.
No
Explanation: The device is a vitrification kit intended for the preservation and thawing of oocytes and embryos. Its purpose is to physically preserve biological material, not to diagnose a condition or disease.
No
The device description clearly states that the device is a "kit" including "solutions" provided in "vials". This indicates a physical product, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD). Here's why:
- Intended Use: The intended use is for the vitrification (freezing) and warming (thawing) of oocytes and embryos. This is a process performed outside the body to preserve biological material.
- Device Description: The device consists of solutions containing cryoprotectants and media components. These are used to facilitate the freezing and thawing process.
- Lack of Diagnostic Purpose: An IVD is a device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or inborn abnormality, or to monitor therapeutic measures. This device does not perform any diagnostic testing or provide information about a patient's health status. It is a tool used in assisted reproductive technology (ART) procedures.
- Performance Studies: The performance studies focus on the effectiveness of the vitrification and warming process (survival rates, pregnancy rates), not on the accuracy of a diagnostic test.
Therefore, the SAGE Vitrification Kit and SAGE Vitrification Warming Kit are considered medical devices used in ART procedures, but they do not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SAGE Vitrification Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
SAGE Vitrification Warming Kit is intended for use in the thawing of virtified oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Product codes
MQL
Device Description
SAGE Vitrification Kit (ART-8025 and ART-8026):
This kit includes two solutions (Equilibration Solution and Vitrification Solutions in the kit consist of a MOPS-buffered media containing non-essential and essential amino acids. gentamicin sulfate, and human serum albumin. These solutions also contain the cryoprotectants ethylene glycol, dimethyl sulfoxide (DMSO) and sucrose as described below:
Equilibration Solution (ES): 7.5% (v/v) each of DMSO and ethylene glycol. Vitrification Solution (VS): 15% (v/v) each of DMSO and ethylene glycol, and 0.6 M sucrose
SAGE Vitrification Warming Kit (ART-8030 and ART 8031):
This kit includes three solutions (1.0M Sucrose Warming Solution [1.0 M WS], 0.5M Sucrose Warming Solution [0.5 M WS], and MOPS Solution [MS]). All solutions in the kit consist of a MOPS-buffered media containing non-essential and essential amino acids, gentamicin sulfate, and human serum albumin. These solutions contain the cryoprotectant sucrose at the level described in their names (i.e., 1.0M, 0.5M, or no sucrose).
Solutions in the SAGE Vitrification Kit and SAGE Vitrification Warming Kit are aseptically-filtered and are provided to users in either 5 ml Type 1 borosilicate glass vials with a rubber closure and an aluminum seal (ART-8025 and ART-8030) or 2 ml polypropylene vials with cap (ART-8026 and ART-8031). The solutions in ART-8025 and ART-8030 are single-use only devices, whereas solution in ART-8026 and ART-8031 are to be used within 7 days after opening.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Performance Testing:
- pH (USP)- 7.2-7.4.
- Osmolality (USP):
- ES: 2331-2849
- VS: 5603-6849
- 1.0 M WS: 1255-1535
- 0.5 M WS: 745-911
- MS: 257-273
- Endotoxin testing (USP): ): No microbial growth
- Shelf-life testing ART-8025 and ART-8030 relied on testing provided in K073522 supporting a 52-week shelf-life as the media and media packaging remained unchanged. Real-time shelf-life testing was conducted on ART-8031 to ensure that the following product specifications were met at time zero and at the end of shelf-life (52 weeks) in closed vials and in vials that were opened and underwent simulated use procedures over the seven days prior to testing: Osmolality, Endotoxin, MEA, Sterility.
Clinical Performance Data: Published journal articles assessing vitrification and warming media that were identical or similar to the subject devices were provided to support extension of the current indication for vitrifying and warming blastocyst stage embryos to also include vitrification and warming of human MII oocytes, pronuclear (PN) zygotes, and day 3 cleavage-stage embryos. In addition, literature was also provided to support use of the subject media for vitrification and warming of collapsed blastocysts in support of methods included in device labeling. The results included in these studies demonstrated that the subject media was capable of vitrifying and warming the oocytes and embryos as shown by their rates of survival, fertilization, and pregnancy/live birth rates.
Oocytes:
- Literature 1 (Selman et al, 2010): 11 subjects, surplus MII oocytes vitrified. Survival rate: 94.1%, fertilization rate: 67.0%, clinical pregnancy rate: 36.4%.
- Literature 2 (Selman et al, 2006): 6 subjects with tubal factor infertility, surplus MII oocytes vitrified. Survival rate: 75.0%, fertilization rate: 77.7%, clinical pregnancy rate: 33.3%.
- Literature 3 (Kupka et al, 2016): Performance in-line with general reported pregnancy rate of 33.6% after transfer of frozen/thawed oocytes.
- Literature 4 (Coello et al, 2016): Control arm with comparable media/procedures. 2353 MII oocytes. Oocyte survival rate: 92.1%, clinical pregnancy rate per embryo transfer: 56.4%, live birth rate per cycle: 45.3%.
- Literature 5 (Gook et al, 2016): Comparable media/procedures, closed vitrification device (54 subjects, 413 MII oocytes). Survival rate: 90.5%, fertilization rate: 64.2%, clinical pregnancy rate: 40.9%.
Pronuclear (PN) Zygotes:
- Literature 6 (Alcolak et al, 2011): Primary media comparable to subject devices. 37 subjects, 74 embryos. Survival rate: 98.6%, 97% of surviving embryos reached cleavage stage. Clinical pregnancy rate: 21.6%.
- Literature 7 (Al-Hasani et al, 2016): Comparable media/procedures. 849 PN zygotes vitrified, 103 cycles of cryopreserved embryo transfer, 339 PN zygotes thawed. Survival rate: 89.0%. Clinical pregnancy rate: 28.2%, 9 live birth events (18 infants), 15 ongoing pregnancies.
Cleavage -Stage Embryos:
- Literature 8 (Selman et al, 2009): 24 warming cycles after fresh cycle cancellation (OHSS risk). Post-warming survival rate: 97.1%, clinical pregnancy rate: 41.6%, implantation rate: 18.0%.
Vitrification of Collapsed Blastocysts:
- Literature 9 (Wan et al, 2014): Control group (102 warming cycles) where blastocyst collapse performed without additional zonal thinning. Post-warming survival rate: 98.0%, clinical pregnancy rate: 35.3%.
Key Results: The studies demonstrated that the subject media was capable of vitrifying and warming the oocytes and embryos as shown by their rates of survival, fertilization, and pregnancy/live birth rates, supporting substantial equivalence to the predicate devices.
Key Metrics
- Survival rate (oocytes, zygotes, embryos)
- Fertilization rate (oocytes)
- Clinical pregnancy rate
- Implantation rate
- Live birth rate
- pH
- Osmolality
- Endotoxin
- Blastocysts at 96h (MEA 1-Cell)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
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March 2, 2018
CooperSurgical, Inc % Tove Kjær Director Corporate Regulatory Affairs ORIGIO a/s Knardrupvej 2 DK-2760 Målov Denmark
Re: K173731
Trade/Device Name: SAGE Vitrification Kit (ART-8025 and ART-8026) SAGE Vitrification Warming Kit (ART-8030 and ART-8031) Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: Class II Product Code: MQL Dated: November 23, 2017 Received: December 6, 2017
Dear Tove Kjær:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173731
Device Name
SAGE Vitrification Kit (ART-8025 and ART-8026) SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
Indications for Use (Describe)
SAGE Vitrification Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
SAGE Vitrification Warming Kit is intended for use in the thawing of virtified oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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a CooperSurgical Company
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510(k) SUMMARY K173731
I. Submitter information
Submitted on behalf of: Mr. James Keller Vice President, Regulatory Affairs and Quality Assurance CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 USA e-mail: James.Keller@coopersurgical.com Phone: +1 (203) - 601 - 5200
Contact person: Ms. Tove Kjær Director Corporate Regulatory Affairs ORIGIO a/s Knardrupvej 2 DK-2760 Måløv Denmark e-mail: tkjaer@origio.com Phone: +45 4679 0220
- II. Date prepared March 2, 2018
III. Device Information:
| Device name: | SAGE Vitrification Kit (ART-8025 and ART-8026)
SAGE Vitrification Warming Kit (ART-8030 and ART-8031) |
|------------------------|----------------------------------------------------------------------------------------------------------|
| Common name: | Vitrification Kit and Vitrification Warming Kit |
| Classification name: | Reproductive media and supplements |
| Classification Number: | 21 CFR 884.6180 |
| Product Code: | MQL (Media, Reproductive) |
| Regulatory Class: | II |
- Predicate device: Vit Kit Freeze (Vitrification Freeze Kit) IV. Vit Kit - Thaw (Vitrification Thaw Kit) K160006
The predicate device has not been subject to a design-related recall.
V. Indication for use
SAGE Vitrification Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
SAGE Vitrification Warming Kit is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
4
VI. Device Description:
SAGE Vitrification Kit (ART-8025 and ART-8026):
This kit includes two solutions (Equilibration Solution and Vitrification Solutions in the kit consist of a MOPS-buffered media containing non-essential and essential amino acids. gentamicin sulfate, and human serum albumin. These solutions also contain the cryoprotectants ethylene glycol, dimethyl sulfoxide (DMSO) and sucrose as described below:
Equilibration Solution (ES): 7.5% (v/v) each of DMSO and ethylene glycol. Vitrification Solution (VS): 15% (v/v) each of DMSO and ethylene glycol, and 0.6 M sucrose
SAGE Vitrification Warming Kit (ART-8030 and ART 8031):
This kit includes three solutions (1.0M Sucrose Warming Solution [1.0 M WS], 0.5M Sucrose Warming Solution [0.5 M WS], and MOPS Solution [MS]). All solutions in the kit consist of a MOPS-buffered media containing non-essential and essential amino acids, gentamicin sulfate, and human serum albumin. These solutions contain the cryoprotectant sucrose at the level described in their names (i.e., 1.0M, 0.5M, or no sucrose).
Solutions in the SAGE Vitrification Kit and SAGE Vitrification Warming Kit are aseptically-filtered and are provided to users in either 5 ml Type 1 borosilicate glass vials with a rubber closure and an aluminum seal (ART-8025 and ART-8030) or 2 ml polypropylene vials with cap (ART-8026 and ART-8031). The solutions in ART-8025 and ART-8030 are single-use only devices, whereas solution in ART-8026 and ART-8031 are to be used within 7 days after opening.
| | Subject device | | Predicate device
(K160006) | | Comparison |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | SAGE Vitrification
Kit
ART8025/
ART8026 | SAGE Vitrification
Warming Kit
ART8030/
ART8031 | Vit-Kit Freeze | Vit-Kit Thaw | N/A |
| Indication for
Use | SAGE Vitrification
Kit is intended for
use in the
vitrification of
oocytes (MII),
pronuclear (PN)
zygotes through
day 3 cleavage
stage embryos
and blastocyst
stage embryos. | SAGE
Vitrification
Warming Kit is
intended for use
in the thawing of
oocytes (MII),
pronuclear (PN)
zygotes through
day 3 cleavage
stage embryos
and blastocyst
stage embryos. | Vit Kit-Freeze
(Vitrification
Freeze Kit) is
intended for
use in the
vitrification of
oocytes (MII),
pronuclear
(PN) zygotes
through day 3
cleavage stage
embryos and
blastocyst
stage embryos. | Vit Kit- Thaw
(Vitrification
Thaw Kit) is
intended for
use in the
thawing of
oocytes (MII),
pronuclear
(PN) zygotes
through day 3
cleavage
stage
embryos and
blastocyst
stage
embryos. | Same |
| Product and performance specification | | | | | |
| pH | 7.20-7.40 | 7.20-7.40 | 7.05-7.54 | 7.05-7.44 | Different - The
pH range is
larger for the |
| | Subject device | | Predicate device
(K160006) | | Comparison |
| Parameter | SAGE Vitrification
Kit
ART8025/
ART8026 | SAGE Vitrification
Warming Kit
ART8030/
ART8031 | Vit-Kit Freeze | Vit-Kit Thaw | N/A |
| | | | | | predicate
devices than the
subject devices.
Differences in pH
do not raise
different Safety
and
effectiveness
(S&E) questions. |
| Osmolality
(mOsm/kg) | ES:
2331-2849
VS:
5603-6849 | 1.0M WS
1255-1535
0.5 M WS
745-911
MS:
257-273 | ES:
1005-1445
VS:
1100-1588 | TS:
1732-1912
DS:
857-910
WS:
268-292 | Different -
Osmolality is
higher in the
subject
vitrification kit
solutions as
compared to the
predicate, while
the warming
solutions of the
subject and
predicate
devices are
similar.
Differences in
osmolality do not
raise different
S&E questions. |
| Endotoxin
(EU/mL) | )- 7.2-7.4 .
- Osmolality (USP)
●
- o ES: 2331-2849
- o VS: 5603-6849
- o 1.0 M WS: 1255-1535
- o 0.5 M WS: 745-911
- o MS: 257-273
- Endotoxin testing (USP) ) No microbial growth ●
- Shelf-life testing ART-8025 and ART-8030 relied on testing provided in K073522 ● supporting a 52-week shelf-life as the media and media packaging remained unchanged. Real-time shelf-life testing was conducted on ART-8031 to ensure that the following product specifications were met at time zero and at the end of shelf-life (52 weeks) in closed vials and in vials that were opened and underwent simulated use procedures over the seven days prior to testing:
7
- Osmolality o
- Endotoxin o
- MEA O
- Sterility O
IX. Clinical Performance Data
Published journal articles assessing vitrification and warming media that were identical or similar to the subject devices were provided to support extension of the current indication for vitrifying and warming blastocyst stage embryos to also include vitrification and warming of human MII oocytes, pronuclear (PN) zygotes, and day 3 cleavage-stage embryos. In addition, literature was also provided to support use of the subject media for vitrification and warming of collapsed blastocysts in support of methods included in device labeling. The results included in these studies demonstrated that the subject media was capable of vitrifying and warming the oocytes and embryos as shown by their rates of survival, fertilization, and pregnancy/live birth rates. A summary of the supporting journal articles is shown below:
Oocytes
- Literature 1: Reports results after oocvte vitrification/warming using SAGE™ Vitrification Kit . and SAGE™ Vitrification Warming Kit. This study included 11 subjects who had their surplus MII oocytes vitrified. Post-warming results showed a survival rate of 94.1%, fertilization rate of 67.0%, and a clinical pregnancy rate of 36.4%.
- Literature 2: Reports results after oocyte vitrification/warming using SAGE™ Vitrification Kit . and SAGE™ Vitrification Warming Kit. The study included six subjects with tubal factor infertility where surplus MII oocytes were vitrified. Post-warming results showed a survival rate of 75.0%, fertilization rate of 77.7%, and a 33.3% clinical pregnancy rate.
- Literature 3: The performance of SAGE™ Vitrification Kit and SAGE™ Vitrification Warming . Kit for vitrification and warming of oocytes was shown to be in-line with general results reported after transfer of frozen/thawed oocytes showing a pregnancy rate of 33.6%.
- . Literature 4: The control arm in this study used media and vitrification/warming procedures determined to be comparable to the subject devices. Results for subjects in the control arm of this study that assessed outcomes following vitrification and warming of 2353 MII oocytes showed an oocyte survival rate of 92.1%, clinical pregnancy rate per embryo transfer of 56.4%, and a live birth rate per cycle of 45.3%.
- Literature 5: This study used media and vitrification procedures determined to be comparable to the subject devices. Clinical oocyte vitrification and warming using a closed vitrification device (54 study subjects and 413 MII oocytes) resulted in a survival rate of 90.5%, fertilization rate of 64.2%, and a clinical pregnancy rate of 40.9%.
Pronuclear (PN) Zygotes
- Literature 6: This study assessed the effectiveness of two vitrification and warming media systems. The primary media was determined to be comparable to the subject devices, while the second media assessed was a commercially available media (RapidVit-Cleave) that included different cryoprotectants than the subject devices. Post-warming in the primary media group including 37 subjects and 74 embryos showed a survival rate of 98.6%, with 97% of surviving embryos reaching the cleavage stage. The clinical pregnancy rate was 21.6%. The clinical pregnancy rate for the primary media system was comparable to that observed for the commercially-available comparator media (23.1%).
8
- Literature 7: This study used media and vitrification procedures determined to be ● comparable to the subject devices. A total of 849 pronuclear-stage (PN) zygotes were vitrified during the study period. During this period. 103 cycles of cryopreserved embryo transfer were completed. In total, 339 PN zygotes were thawed resulting in an 89.0% survival rate. The clinical pregnancy rate obtained was 28.2%, resulting in 9 live birth events (18 infants) with 15 ongoing pregnancies.
Cleavage -Stage Embryos
- Literature 8: Reported prospective outcomes following vitrification and warming of cleavage ● stage embryos using the SAGE™ Vitrification Kit and SAGE™ Vitrification Warming Kit. The study included 24 warming cycles after fresh cycle cancellation due to risk of Ovarian Hyperstimulation Syndrome (OHSS). Results showed a post-warming survival rate of 97.1%, a clinical pregnancy rate of 41.6% and an implantation rate of 18.0%.
Vitrification of Collapsed Blastocysts
- Literature 9: Reports data after vitrification/warming of collapsed blastocysts generated ● from lower grade cleavage-stage embryos using the SAGE™ Vitrification Kit and SAGE™ Vitrification Warming Kit. Results from the control group (102 warming cycles) in this randomized controlled trial where blastocyst collapse was performed without additional zonal thinning showed a post-warming survival rate of 98.0% and a clinical pregnancy rate of 35.3%.
X. Conclusion
The results of the performance information summarized above demonstrated that the subject devices are as safe and effective as the predicate devices and supports substantial equivalence.
References XI.
-
- Pregnancies and deliveries after injection of vitrified-warded oocytes with cryopreserved testicular sperm. (Selman et al, (2010) Fertility and Sterility Vol. 94(7):2927-2929).
-
- Ongoing pregnancies after vitrification of human oocytes using a combined solution of ethylene glycol and dimethyl sulfoxide. (Selman et al. (2006) Fertility 86(4):997-1000).
-
- Assisted reproductive technology in Europe, 2011: results generated from European registers by ESHRE. (Kupka et al (2016) Human Reproduction 31(2): 233-248).
-
- A combination of hydroxypropyl cellulose and trehalose as supplementation for vitrification of human oocytes: a retrospective cohort study. (Coello et al (2016) Journal of Assisted Reproduction Genetics 33(3): 413-421).
-
- Closed vitrification of human oocytes and blastocysts: outcomes from a series of clinical cases. (Gook et al, (2016) J Assist Reprod Genet 33: 1247-1252).
-
- Comparison of two different media for vitrification and rewarming of human zygotes: Prospective randomized study. (Alcolak et al, (2011) Middle East Fertility Society Journal 16:189-193).
-
- Three years of routine vitrification of human zygotes: is it still fair to advocate slow-rate freezing? (Al-Hasani et al. (2016) Reproductive BioMedicine Online 14(3):288-293).
-
- Vitrification is a highly efficient method to cryopreserve human embryos in in-vitro fertilization patients at high risk of developing ovarian hyperstimulation syndrome (Selman et al, (2009) Fertility and Sterility 91(4):1611-1613).
-
- Laser-assisted hatching improves clinical outcomes of vitrified-warmed blastocysts developed from low-grade cleavage-stage embryos: a prospective randomized study. (Wan et al, (2014) Reproductive BioMedicine Online 28:582-589).