SETTING UP IUI AND IVF SERVICES
Dr. Priya Bhave Chittawar
MD,DNB,Fellowship In Reproductive Medicine,
Mohak Hitech Speciality Hospital
Laparoscopy and Infertility Center
MP chapter ISAR
Dr. Asha Baxi
Dr. Shilpa and all teammates @Mohak
SCOPE OF THE PRESENTATION
Components of setting up ART services
Good lab design
Good service provision
Points to Ponder
What type of service are you thinking of?
Which is your target population?
When do you want to start/expand?
Who are your teammates?
Why do you want to start an ART service?
How much can you invest?
The ART Regulation draft bill:
Primary (Level 1)
Secondary (Level 2)
Tertiary (Level 3)
The TRY Angle
Use the existing clinical area for consulting, scan,
pathology and injection rooms.
The collection room : Separate exit, connection
to the lab, privacy, aids
Andrology lab: Sterility , connected to IUI room
and collection rooms.
Separate time/area for infertility patients.
Concept derived from the pharma industry. How clean
is your room?
Chemically active compounds
Volatile organic compounds
Embryo does not have liver/kidney /lungs
or a nose either!
AT REST (B) IN OPERATION
Maximum permitted number of particles/m3 equal to or
0.5 Um 5 Um 0.5 Um 5 Um
A 3500 0 3500 0
B (a) 3500 0 350 000 2000
C (a) 350 000 2000 3 500 000 20000
D (a) 3 500 000 20 000 not defined (c) not defined (c)
EU directive 2004/22/EC stipulates quality
requirements when human tissues and cells are
Where tissues or cells are exposed to
environmant during processing, air quality with
particle counts and microbial quality counts
equivalent to those of Grade A as defined in GMP
guidelines is essential.
“I use a laminar air flow. It provides
me a Grade A environment!”
Laminar air flow can achieve a Grade A
environment only if incoming air is of
grade B or at least C!
The key to setting up a good lab is to think like
The quality of air in your lab makes the difference
between good and exceptional results
You can buy better equipments or replace them
Can you change your building as easily?
What We Did?
Choice between a centrally located hospital with
excellent visibility , patient input and accessibility
and building from a scratch in a pollution free
area far off from the city.
We chose to build from ground up so that we are
embryo friendly all the way.
What is ideal ?1
What is feasible ?2
What is viable?3
Ideally the second floor.
Area: depends on workload expected
Basic air sampling and VOC determination
Is any modification/renovation planned
30 to 40 square meters
Ducts , pipes placed outside
Know thy neighbour
Love thy neighbour
Make sure your neighbour loves you back
Renovation/modification in neighbouring areas
will influence your results.
Changing vinyl flooring caused dramatic fall in PR
Painting in the building: esp if oil based.
Air Handling Unit
Heating, Ventilation and Air Conditioning
Provides air changes and pressure differential
HEPA filters : Particles
Charcoal : VOC
UV light : Microbes
Maintenance and monitoring
Smaller mobile units also available
Over pressured (0.10 – 0.20 inches of water )
+ 7-15 air changes per hour.
100% outside air
Lab temperature 26 to 28 degrees
Layout of equipment
Space air outlets to avoid drafts
Transient cooling to room temperature can cause
irreversible of meiotic spindle in human oocyte.
Pickering et al.(FertilSteril 54,102-108)
Limited recovery of meiotic spindles in live
human oocytes after cooling rewarming observed
using polarized microscope. Wang et al (HumRep
Evidence around Air Quality
Paucity of evidence
Urgent need to generate good quality evidence to
develop norms for IVF labs
Effect of VOC on ART outcome, Cohen et al (Hum
Critical (zero tolerance to interruption)
Critical (interruption allowed but needs backup
Non critical with backup
Non critical without backup
TVOR theatre: Oxygen and suction
IVF lab: CO2 and trigas supply.
Dirty corridor for cylinders
Number and position of incubators, today and
Piped supply is ideal- flowmeter within the lab.
Copper pipes leach Cu ions in the gas supply.
The TRY Angle
Instruments and Equipments
Beware and be wary!
Three types: Essential, Desirable and
Look at track record and service commitment
Pick and choose
Frills can be expensive
Essential : Centrifuge, Laminar air flow hood,
Microscopes (Light), Incubator, Test tube warmer
Desirable: Phase contrast microscope, Mackler
chamber, CO2 incubator
The TRY Angle
Unlike Obstetrics and Gynecology where individual
skill and talent brings credit and recognition.
Essentially a ‘TEAM’
One weak link in the chain can spell disaster for the
entire team and reflect on results.
Training, motivation and spirit.
Collection of brilliant minds or brilliant collection
Non medical members are as important.
Good IVF nurse can be the backbone of the unit.
Embryologist is the soul of your programme.
Don’t forget the cleaner!
Attrition is inevitable
Keeping updated is important for all the
members, not only the lead clinician.
The average cost of essential equipment for an IUI
setup is 1.0 to 1.5 lakhs
The cost of equipments for an IVF ICSI setup is
around 40 lakhs.
The cost of equipments in an ideal setup is close to
Infrastruture cost is about 40 to 50 lakhs.
Clinical services like ultrasound, pathology,
Think of Economics but don’t think Economically !
Effective service provision
Patient centered services.
You cannot always be successful, but you can still
Elements of Good Lab Design
The five elements :
Prithvi = Building
Agni = Incubators
Jal = Water
Vayu =Lab air
Aakash= Culture system
Take Home Message
The five questions: why, when, what, where, who
and how much
The five elements of good lab design
The five elements of service provision
The five fingers coming together to form a fist:
Dr Shilpa Bhandari
Deptt Of Obst and