3. ANDROFERT
空气质量在IVF的重要性
动物/实验性研究证据
Study Population Method Outcome
Little and
Mirkes, 1990
In vitro
cultured rat
embryos
Protein and DNA
analysis
High levels of acrolein associated
with embryotoxicity
Cohen et al,
1997
Analytical
measurement
procedure
Air sampling and VOC
determination in
human IVF labs
Higher levels of VOC in HEPA-
filtered lab ambient air and
incubators compared with outside
ambient air
Hall et al,
1998
Analytical
measurement
procedure and
bioassay
Air sampling and VOC
determination in
human IVF
laboratories; acrolein
bioassay using 2-cell
mouse embryos
Increased levels of VOC in ambient
air. Reduction in aldehyde levels by
air filtration using carbon-activated
and permanganate. In vitro mouse
embryo development, implantation
and post-implantation outcome
inversely correlated with acrolein
levels
Worrillow et
al, 2002
Analytical
measurement
procedure
Design of a high
velocity air control
system and laboratory
with VOC air filtration
IVF laboratory and procedure
rooms qualified as class 100 areas.
No VOCs found above >0.1 parts
per billion
4. ANDROFERT
空气质量在IVF的重要性
人类观察性研究证据
Study Population Method Outcome
Mayer et al,
1999
RCT of infertile
IVF couples
Embryo culture in
incubators with and
without VOC filtration
Higher PRs when embryos were
cultured in incubators with VOC
filters
Racowsky et
al, 1999
Infertile IVF
couples,
observational
IVF and embryo
culture in labs and
incubators with and
without VOC filtration
Reduction in miscarriage in cycles
performed in labs and incubators
with carbon-activated filters
Boone et al,
1999
Infertile IVF
couples,
observational
Construction of
cleanrooms for IVF
activities
Reduction in air particles
associated with an increase in the
number of high-quality embryos
Worrillow et
al, 2002
Infertile IVF
couples,
observational
IVF in clean rooms
with VOC filtration.
Outside and inside
ambient air monitored
for 2 years
Seasonal correlation between
temperature/humidity of outside
ambient air serving the IVF air
system and VOC levels with impact
on IR
Knaggs et
al, 2007
Infertile IVF
couples,
observational
IVF lab redesigned to
meet the EU directive
Implantation and pregnancy rates
increased after the move into the
cleanroom
8. Region
(directive)
European Union (EU directive
2004/23/EC; 2006/86/EC)
Brazil (Anvisa
RDC33/2006;
RDC23/2011)
Particle
filtration
Equivalent to GMP Grade A
air quality in the critical areas
with a background
environment at least
equivalent to Grade D
(exceptions apply)
At least equivalent
to ISO class 5 (NBR/
ISO 14644–1) in the
critical areas
Microbial
contaminatio
n
Microbial colony counts
equivalent to those of Grade
A as defined in the current
GMP guide with a background
environment at least
equivalent to Grade D
Microbiological
monitoring
required;
specifications not
defined
Volatile
organic
compounds
filtration
Not required Ventilation systems
should be equipped
with filters
imbedded with
activated charcoal
ANDROFERT
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2014 March
ANDROFERT
14. 生殖实验室VOC含量
Indoor air
Personnel
Material and
Equipment
Cell, tissue
and fluids
5-fold increase in VOC
Anderson et al. 1997
ANDROFERT
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ANDROFERT
21. ANDROFERT
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ANDROFERT
Particle size/m3 of air: ISO 14.644-1
0.3 µM
0.5 µM
1 µM
5 µM
ISO 1
ISO 2
10
4
ISO 3
102
35
8
ISO 4
1,020
352
83
IVF
lab
ISO 5
10,200
3,520
832
29
ISO 6
102,000
35,200
8,320
293
OR
ISO 7
352,000
83,200
2,930
Transfer
ISO 8
3,520,000
832,000
29,300
ISO 9
35,200,000
8,320,000
293,000
洁净室分级
34. Esteves & Bento. RBM Online 2013
ü 经核准通过标准
ANDROFERT
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SC ESTEVES, 34
2014 March
ANDROFERT
36. 空气质控 & IVF 结局
2,315个病人; 14,660 个胚胎
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
Before After
2002-‐
2004
After
2005-‐
2007
After
2008-‐
2010
TQE
D3
(%)
Miscarriage
(%)
LBR
fresh
(%)
ANDROFERT
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SC ESTEVES, 36
2014 March
ANDROFERT
37. 平均每个病人可多获得一个胚胎
用于移植或冷冻
空气质控 & IVF 结局
2,315 patients; 14,660 embryos
ANDROFERT
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2014 March
ANDROFERT
38. IVF累计妊娠率
Esteves, 38 ANDROFERT, Referral Center for Male Reproduction
ET #3
(FET) 49
ET #2 (FET)
239
ET #1 (fresh)
822
50.5%
+18.8%
+25.0%Female
Age
≤38
ANDROFERT
332/822 63/239 17/49