1. SETTING UP IUI AND IVF SERVICES
Dr. Priya Bhave Chittawar
MD,DNB,Fellowship In Reproductive Medicine,
Head,Reproductive Medicine
Mohak Hitech Speciality Hospital
Laparoscopy and Infertility Center

2. Thanks!
 IOGS
 MP chapter ISAR
 Dr. Asha Baxi
 Dr. Shilpa and all teammates @Mohak

3. SCOPE OF THE PRESENTATION
 Components of setting up ART services
 Good lab design
 Good service provision
From How?
to Wow!

4. 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?

5. The ART Regulation draft bill:
 Primary (Level 1)
 Secondary (Level 2)
 Tertiary (Level 3)

6. The TRY Angle
INFRASTRUCTURE
EQUIPMENT PERSONNEL

7. IUI services
 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.

8. Clean Room
Concept derived from the pharma industry. How clean
is your room?
Particles
Chemically active compounds
Volatile organic compounds
Microbes

9. Embryo does not have liver/kidney /lungs
or a nose either!

10. AT REST (B) IN OPERATION
Grade
Maximum permitted number of particles/m3 equal to or
above
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)

11.  EU directive 2004/22/EC stipulates quality
requirements when human tissues and cells are
handled
 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.

14. “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!

15.  The key to setting up a good lab is to think like
the embryo
 The quality of air in your lab makes the difference
between good and exceptional results
 You can buy better equipments or replace them
anytime
 Can you change your building as easily?

16. 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.

17. What is ideal ?1
What is feasible ?2
What is viable?3

18. The Building
 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

19.  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.

20. Walls
Ceiling
Lights
Floor
Storage
IVF LAB
Doors
AHU

21. Kwality Walls!
Solid surface GI SS Epoxy Tiles
Ease of Maintenance +++ + + - -
Antimicrobial +++ + + + -
Durable +++ + + + -
Sustainable +++ + + + -
No offgassing +++ + ++ ++ +
Seamless +++ - - + -
Resilient ++++ ++ +++ + -
Non Reflective ++++ + - +++ ++
Installation and assembly + ++ ++ +++ ++
COST +++++ ++ +++ ++ +

22. 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

23.  Over pressured (0.10 – 0.20 inches of water )
+ 7-15 air changes per hour.
 100% outside air
 Lab temperature 26 to 28 degrees
 Humidity <40%
 Layout of equipment
 Space air outlets to avoid drafts

24.  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
16,2374-2378)

26. 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
Rep 12,1997)

29. Electricity
 Critical (zero tolerance to interruption)
 Critical (interruption allowed but needs backup
within seconds)
 Non critical with backup
 Non critical without backup

30. Gas supply
 TVOR theatre: Oxygen and suction
 IVF lab: CO2 and trigas supply.
 Dirty corridor for cylinders
 Number and position of incubators, today and
tomorrow.
 Piped supply is ideal- flowmeter within the lab.
 Copper pipes leach Cu ions in the gas supply.

31. The TRY Angle
INFRASTRUCTURE
EQUIPMENT PERSONNEL

32. Instruments and Equipments
 Bewildering
 Beware and be wary!
 Three types: Essential, Desirable and
Experimental
 Look at track record and service commitment
 Pick and choose
 Frills can be expensive

33. IUI LAB
1. Equipments:
 Essential : Centrifuge, Laminar air flow hood,
Microscopes (Light), Incubator, Test tube warmer
 Desirable: Phase contrast microscope, Mackler
chamber, CO2 incubator
 Experimental: CASA
2. Disposables

34. IVF Lab
1. Essential : Suction pump, tube heaters,
Cryopreservation equipment, Incubators, Bio
safety cabinet , micromanipulator.
2. Desirable: IVF Chamber, LASER, Low O2
incubators, CO2 analyzer, TC thermometer
3. Experimental : IMSI, Polscope, metabolomics

35. The TRY Angle
INFRASTRUCTURE
EQUIPMENT PERSONNEL

36. PERSONNEL
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
of minds?

37. The Clinicians: Infertility specialist, Sonologist,
Pathologist, Andrologist
The Embryology Team: Lab Director, Junior
Embryologists
The IVF Nurse
Counselor
Cleaning staff
Geneticist

38. 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.

40. FINANCE
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
100K
Infrastruture cost is about 40 to 50 lakhs.
Clinical services like ultrasound, pathology,
consulting chambers.

41. Think of Economics but don’t think Economically !

42. Effective service provision
Patient centered services.
Safety
Timely
Effective
Efficient
You cannot always be successful, but you can still
succeed.

43. Elements of Good Lab Design
The five elements :
Prithvi = Building
Agni = Incubators
Jal = Water
Vayu =Lab air
Aakash= Culture system

44. 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:
Team approach.

46. Dr Shilpa Bhandari
Mr.Charudutt Joshi
Dipthi Repalle
Dr.Vandana Kumawat
Gitanjali Joshi
Pawan Kumar
Mr.Jitendra
Sunita,Savita,Hemlata
Deptt Of Obst and
Gynecology,SAIMS