Describes restart of Fertility services

1. Resumption of ART Cycles Post COVID
Taking the threat seriously

2. • Dr Shivani Sachdev Gour
• MD DNB MRCOG (UK)
• Consultant Fertility
Specialist Gynaecologist
• Director
• SCI IVF Centre New Delhi
• DR Nupur Garg
• MS, FNB
Consultant Fertility
Specialist Gynaecologist
• Director
SCI IVF Centre Noida

3. KEY RECOMMENDATIONS-ASRM March 13 2020
1. Suspend initiation of new treatment cycles, including ovulation induction,
intrauterine inseminations (IUIs), in vitro fertilization (IVF) including
retrievals and frozen embryo transfers, as well as non-urgent gamete
cryopreservation.
2. Strongly consider cancellation of all embryo transfers whether fresh or frozen.
3. Continue to care for patients who are currently “in-cycle” or who require urgent
stimulation and cryopreservation.
4. Suspend elective surgeries and non-urgent diagnostic procedures.
5. Minimize in-person interactions and increase utilization of telehealth.

4. ART and COVID-19 ESHRE 2/4/20
ESHRE advises that ART should not be started at present for the following
reasons:
• To avoid complications from ART/ potential SARS-CoV-2 related
complications during pregnancy
• To mitigate the unknown risk of vertical transmission in SARS-CoV-2 pt
• To support the necessary reallocation of healthcare resources
• To observe the current recommendations of social distancing.
In cases of urgent fertility preservation in oncology patients, the
cryopreservation of gametes, embryos or tissue should still be considered.
European Society of Human Reproduction and Embryology

6. Denmark
restart
20/4/20
India
Sweden
some
clinics
stayed
open
Australia
IVFclinics
restarted
21 to 27
April 2020
Germany
restart as
per ESHRE
Canada
Restart as
per local
jurisdiction
UK Restart
May 2020
as per
HFEA
USA clinics
some
stayed
open/
restarted

7. • Flu like illness is a serious problem every year, What
is different now? How is corona different from flu or
viruses like Ebola or HINI?

8. COVID-19 not like normal seasonal Flu
• The pathophysiology, epidemiology and transmission dynamics
of COVID-19 are not fully understood.
• There are currently no specific medications
for the treatment of COVID-19.
• COVID-19 is a “novel” infection and host immunity is assumed
to be minimal.
• COVID-19 is more contagious than the flu.
• COVID-19 has a 10 to 15-fold greater mortality rate than the flu.
• Unclear whether the current proposed drug can be used safely in
pregnant or breastfeeding women
• COVID-19 impacts the lungs differently than does the flu.

9. 9
Onder G JAMA 2020,Verity R Lancet Infec Dis
2020

10. UNDERSTANDING BASICS
• Particles > 5 to 10 micron –
called respiratory droplets
• < 5 microns are called droplet
nuclei/ aerosols
• SarsCov2 transmission is
believed to be through
droplets and direct contact
• feco oral transmission ?
• Recent Reports (MIT) Social
distancing may need to be 27
feet?? (instead of 6 feet)

11. Where do we stand in the
epidemic curve?

12. Where do we stand in the epidemic curve?

13. • Growth rate <5 % or
Growth factor <1
indicate stabilisation
and decline
• India’s R vale (4/5/20
as per news
updates)1.36

14. Have we reached point of
stabilisation?
Many countries now reporting stabilisation of infection
• Australia
• Spain
• Italy
• China
• Germany

16. • Should Infertility Treatment Be Considered Non
Essential?

17. Should Infertility Treatment Be Considered Non Essential?
• Although infertility does not jeopardize the physical survival of
infertile couples, it does jeopardize their future quality of life
• Treatment of infertility is medically necessary
• It is time sensitive and extremely important (such as IVF) but not
a medical emergency.

18. Date of
publication: 6th
May 2020
Tell us about the Best practice guidelines
for reintroduction of routine fertility
treatments during the COVID-19 pandemic
by ARCS and BFS

19. It states that : ARCS and the BFS published initial guidance on 16th March,
which was updated and expanded on the 18th March 2020,
Recommended that ART centres cease all elective treatment activity asap to
reduce the potential burden on the NHS from treatment complications, ensure
social distancing, reduce risk of viral infection for patients and free up essential
resources to aid in the fight against the pandemic.
Then on 23rd March 20 HFEA published General Direction 14
It which limited treatments to fertility preservation in patients who were, in
the written opinion of a registered medical practitioner, likely to become
prematurely infertile.

20. Guidelines updated 6/5/20
The following 5 principles underpin the approach taken
in developing this guidance:
1. Resumption of fertility services must take place in a
manner that minimises the chances of spread of
COVID-19 infection to patients and fertility clinic staff.
2. Centres should ensure a fair and transparent
approach to any prioritisation policy.

21. 3. Resumption should not result in an undue burden on the NHS.
4. Patients should be fully informed about the effect of the
ongoing pandemic on their treatment and give informed consent
to having fertility treatment at this time.
5. The fertility sector should adopt sustainable changes in
working practices that help to build resilience against any future
increases in the spread of COVID-19 in the community.
Five Key Principles

22. ESHRE updated statement on
restarting ART

23. ESHRE Released statement
23 April 2020
As the COVID-19 pandemic is stabilising, the return to normal daily life will also
see the need to restart the provison of ART treatments. Infertility is a disease
and once the risk of SARS-CoV-2/COVID-19 infection is decreasing, all ART
treatments can be restarted for any clinical indication, in line with
local regulations.

24. Resumption of ART
6 pillars of good medical practice
1. Discussion, agreement and consent to the start of treatment
2. Staff and patient triage
3. Access to advice and treatment
4. Adaptation of ART services
5. Treatment cycle planning
6. Code of Conduct for staff and patients

25. HOW TO ENSURE PATIENT SAFETY

26. a.Information and consent
Patients are likely to be anxious about coronavirus and its potential effects on pregnancy.
Patients should be made aware that the present experience is limited and does not
indicate that the severity of infection is any worse in pregnancy, there is no evidence of
an increased risk of fetal anomalies (RCOG)
Patients should be carefully counselled, taking into account their individual clinical
situation and risk profile, and the likely persistence of the virus in the local community
This counselling and the patient's decision whether or
not to proceed with fertility treatment should be
documented in the medical record.
Ensuring patient safety

27. Patient education
• Tutorials on the use of personal protective equipment (PPE)
• Advice on continuation of social distancing and avoidance of
unnecessary human physical contact.
• Information about symptoms of SARS-CoV-2/COVID-19 infection
or exposure occurrence
• Agreement that treatment can be discontinued if the patient
encounters a high-risk situation

28. HOW TO PRIORITISE PATIENTS

29. Prioritisation
Fertility preservation for patients facing cancer
chemotherapy
In addition, it is reasonable to prioritise patients in whom delay is most likely to
significantly affect the outcome of treatment.
those with a low ovarian reserve, advanced age and those facing
extirpative pelvic surgery (for instance due to severe endometriosis
or bilateral ovarian cysts).
The above list is not exhaustive

30. ANY SPECIAL CAUTIONS for particular
group of patients

31. Particular caution
In patients whose co-morbidity places them at a higher risk of
complications in the event of contracting coronavirus infection.e,g
obesity, hypertension, diabetes and those receiving
immunosuppressive medication.
Such patients may delay conception until
epidemiological evidence shows a sustained reduction in
the community spread of the infection.

32. • High-risk patients (e.g. diabetes, hypertension, using immunosuppressant therapy, past transplant patients,
lung, liver or renal disease) should not start ART treatment until it is deemed safe to do so .
• All patients should be offered a choice to proceed with or postpone their ART treatment
• In both cases patient preference should be clearly documented.
• Patients must be comprehensively informed, the risks related to COVID-19 disease and the increased
risks in case of infection during pregnancy.
• Patients must also be informed on how to reduce the risk of infection in general.
• Patients must sign and adhere to the Code of Conduct.

33. TELL US ABOUT TRAIGING SCREENING
BEFORE STARTING TREATMENT

34. Triaging, Screening and Testing
Before starting treatment:
1. A screening questionnaire
2. Antigen test (if available)
Patients and donors with a diagnosis of COVID-19 infection should not start treatment until
they have recovered and are not considered infectious. National guidelines should be
followed in this regard. Centres should consider whether they advise patients and
potential donors to self-isolate, if possible, from the start of
ovarian stimulation treatment until egg collection.

35. Triaging Questionnaire for Covid-19
Have YOU or YOUR PARTNER or ANY MEMBER OF YOUR HOUSEHOLD been diagnosed with
Covid19?
Have YOU or YOUR PARTNER or ANY MEMBER OF YOUR HOUSEHOLD had any of the
following symptoms in the last 2 weeks
1. Fever (feeling hot or temp >37.5)
2. 2. Persistent cough
3. 3. Loss of the sense of smell
4. 4. Loss of the sense of taste
5. 5. Sore throat
Have YOU been in contact with anyone in the last 2 weeks who has any of these
symptoms or has been diagnosed with Covid-19?

36. Any difference between this and Eshre
guidelines

38. Patients
• All patients planning to start treatment to undergo triage questionnaire (paper, email or phone)
two weeks before commencing treatment.
• Triage of both partners two weeks before starting the ART treatment.
• A further triage of both partners during ovarian stimulation.
• Medical evidence of clearance from all patients with a previous confirmed COVID-19 infection
• If patients have been on respiratory support during the COVID-19 infection episode, additional
evidence of fitness assessment and a medical specialist report.

40. TRAIGING SCREENING DURING
TREATMENT AND WHAT IF TEST
FOR COVID19 IS POSITIVE

41. Triaging, Screening and Testing
During treatment:
A coronavirus screening questionnaire should be
administered prior to every clinic visit.
Patients and donors with a negative coronvirus antigen test at the start and who remain
negative on questionnaire throughout should be allowed to complete treatment.
Consideration should be given to performing a further antigen test as
close as reasonably possible to any surgical procedure depending
upon local guidelines and availability of testing.

42. Action in the event of suspected COVID-19:
If a patient or donor develops symptoms / or screens positive on the questionnaire
(RTPCR ) antigen screen should be arranged
treatment should not proceed unless the patient screens negative .
If patient or donor presents with suspected or confirmed Covid-19 after the ovulatory
trigger, a multidisciplinary individual risk assessment should take place to balance the
risks of refraining from oocyte retrieval against those of proceeding.
Patients who become symptomatic after oocyte retrieval but prior to embryo transfer
should be advised to freeze all their embryos for future use.

43. HOW TO REDUCE FACE TO FACE
INTERACTION
Dr Poornima Durga

44. Reducing face-to-face interactions
Frequency and duration of visits required may be reduced.
Use Telephone and video consultations - ensure that any software used meets the
requirements of data protection.
Clinicians may require training in the performance of ‘virtual’ consultations,
including the need for confidentiality, accurate patient identification and provision of
sufficient time for patients to assimilate information and ask questions.
Recording and Consent for fertility treatment may be taken remotely, provided the
clinician is satisfied that the patient thoroughly understands the implications of consenting.
Software packages exist to aid this process.

45. Reducing face-to-face interactions
Use of videos and podcasts that can be accessed from home, avoiding the need for
patients to congregate in large numbers. Online counselling options
Reduce the number of visits required for monitoring ovarian
stimulation, particularly in women with a normal ovarian reserve.
Minimise the number of accompanying persons.
Virtual consultations, including those where an interpreter is needed, offer a way of
managing care safely without the need for multiple attendees in person

46. HOW TO MINIMISE CLINICAL RISK

47. Minimising clinical risk
Clinical protocols to minimise the risk of OHSS
GnRH-Antagonist protocol and GnRH-agonist trigger in
appropriate cases.
Minimise the risk of hospital admission for patients
Operative and infective complications following oocyte retrieval are rare, and preventative
measures such as prophylactic antibiotics should be considered to reduce risk where
appropriate.
The use of empirical immunosuppressive
treatments should be avoided.

48. Tell us about precautions for the staff
will you advise staff to do Covid19 test
will you advise staff to take HCQ
prophylaxis?

49. Staff
• Triage information should start at least two weeks before the beginning of clinical
activities at the centre.
• Staff should be subdivided in “mini-teams” with minimum interactions among them.
• Teams should work according to a rotating schedule, similar to the one adopted for
weekend work

51. Adaptation of ART services
• Sanitation
• Staff and centre adaptation
• Access procedures

52. • SANITATION/ DISINFECTION REARRANGEMENT OF
CLINIC

53. Sanitation
• Routine sanitation of all areas should be performed
according to local protocols.
• Specific COVID-19 sanitation procedures should be
implemented in case of COVID-19 positive patients or
staff members.

54. Disinfection
• For surface cleaning and disinfection, agents that are useful are alcohol or chlorine based.
• Alcohol based agents should contain 70% isopropyl alcohol.
• Chlorine based solutions are prepared by diluting liquid chlorine (1000 mg/L strength) or freshly
prepared 1% sodium hypochlorite solution.
• The appropriate concentration of sodium hypochlorite for disinfecting general liquid biological waste is
approximately 1%.
• Household bleach is 5 - 6 % sodium hypochlorite; therefore a 1:5 (v/v) dilution of bleach to liquid
biological waste is appropriate.
• The contact time of these solutions should be at least 30 minutes.

55. VENUE SANITATION AND REARANGEMENT
Waiting Room
• Distance seating
• Mask for symptomatic
• All indoor areas, waiting chairs should be should be mopped with a 1% sodium
hypochlorite solution or phenolic disinfectants
• The frequency of mopping will depend on the footfall. At 2–3 patients an hour,
2 h mopping is recommended.
• Hand sanitisation at entry

56. Checking Desk
Physical barriers, such as glass or plastic windows panels, should be used or distance of 6 feet to be
kept
High contact surfaces telephones, printers/ scanners cleaned twice daily by mopping with a
linen/absorbable cloth soaked in 1% sodium hypochlorite
Frequently touched areas like table tops, chairs, chair handles, pens, office files, registers, keyboards,
mouse, mouse pad, tea/coffee dispensing machines etc. should specially be cleaned with 1% sodium
hypochlorite or a sanitiser that contains at least 60–70% alcohol.
Hand sanitising stations at clinic registration counters
Gloves for reception registrar
Patient Room
Bed,chair,door handle,computer wiped down with sanitising wipes or spray after each patient
visit

57. TELL US MORE ABOUT STAFF AND
CENTRE ADAPTATION

58. Staff and centre adaptation
• COVID-19-specific training
• COVID-19-specific standard operating procedures
• Adjusted work shifts
• Emergency agreements between ART centres to
guarantee continuity of treatment provision

59. Access procedures
• Limitation of the number of persons simultaneously present in the centre
• Provision of protective screens for administrative staff
• Provision of personal protective equipment and sanitation devices for patients and staff
• Restriction of access for partners and accompanying persons
• Redesign of waiting rooms and working spaces to guarantee appropriate distancing
• Management of appointments according to specific timetables, also for scans and blood tests

60. • Subdivision of staff into mini-teams to reduce unnecessary
exposure of patients and staff members
• Follow-up of patients three weeks after oocyte retrieval and/or
embryo transfer, in order to identify potential COVID-19
positive patients and implement necessary measures (i.e.
contact tracing and sanitation

61. • PLEASE TELL US ABOUT PRECAUTIONS and
SANITISATION DURING SCANS

62. Precautions while doing Scans
• Patient examination tables
sheets and pillow covers must
be changed after each patient.

63. • Mattresses and table edges must be sanitised using a sanitiser
containing 60–70% alcohol or a 1% sodium hypochlorite solution.

65. Equipment Sanitation
• Excess ultrasound gel on the transducer should be wiped off after each examination
• Transducer surfaces and cords should be wiped with low level disinfectant (LLD)
include 70% Alcohol, 10% Bleach, Clorox, standard dilute Cidex, Protex wipes,
SaniCloth, PI Spray, Oxivir wipes, Mikrobac, Microzid, Lonza, Klercide70,
Descocept wipes
• Equipment desktop, edges, keyboard, transducer resting stands and especially the
side in close proximity to the patient should be wiped with an LLD.
• Cloths may be laundered with standard machine-washing.
• Transvaginal probes are classified as semi-critical items that should be high-level
disinfected between patients.

66. TELL US ABOUT EGG COLLECTION AND
ET PROCEDURE IN COVID19 ERA

67. TVS PROBE
• FDA has approved ortho-phthaladehyde (OPA),
hydrogen peroxide, glutaraldehyde, and peracetic
acid with hydrogen peroxide as high-level
disinfectants.
• Place transvaginal probe into Cidex OPA solution
and clip cord to the holder to ensure the top of the
probe does not hit the bottom of the Cidex
container.
• Soak probe for 12 minutes in Cidex OPA
• Remove from Cidex, rinse under water for one
minute, wipe dry.

68. Oocyte retrieval
• Scenario I : Follow standard procedures unless changes occur between ovulation trigger
and oocyte retrieval
• Scenario II : If positive re-triage, consider SARS-CoV-2 IgM/IgG and/or RT-PCR
testing for COVID-19. Based on the result, decide whether to continue the treatment or to
postpone it.
• Scenario III :If the patient tests positive for SARS-CoV-2/COVID-19, before ovulation
trigger or embryo thawing, postpone treatment, refer and isolate.
• Exception:Patients at risk of OHSS and fertility preservation

69. ART in COVID positive
• FFP2/3 masks according to clinical duty requirements
• Gowning
• Disinfection of operating theatre, transfer room and IVF laboratory
after the procedure
• The procedure should be cancelled for newly diagnosed COVID-
19 positive patients.

70. Embryo transfer
• Limit the number of staff members in the transfer room
• Restrict access for accompanying person(s)
• Perform transfer only in cases of low risk/asymptomatic patients and partners
• Apply a freeze-all policy for all patients and/or partners who became
symptomatic after the oocyte retrieval.

71. • Can Virus be transmitted through gametes?

72. • SARS-CoV-2 cannot enter cells that do not carry ACE2 on the surface
• ACE 2 receptors were not found on mature human spermatozoa and oocytes
• But ACE2 receptors were reportedly detected in Leydig and Sertoli cells and spermatogonia of the
human testis (Wang and Xu, 2020) as well as in theca and granulosa cells of the human ovary (Reis et
al., 2011).
• Currently no evidence of transmission of virus in reproductive cells
• La Marca Fert Stert 2020, Schwartz and Graham,Viruses 2020,Jan Tesarik RBM 2020

73. • ABOUT CRYOPRESERVATION

74. Cryopreservation
• High security straws and/or vapour phase storage tanks should be
used for cryopreservation of samples from COVID-19 positive
patients

75. • PLEASE TELL US ABOUT LABORATORY ASPECTS
including the Air Handling Unit

76. Laboratory
• Routine good laboratory practice should be followed and laboratory staff should wear masks and gloves.
• Staff should be organised in mini-teams.
• Extra care should be taken to reduce exposure to native follicular fluid and sperm by dilution and safe disposal of fluids in
individual closed containers, as quickly as possible.
• Guidelines and good laboratory practice principles should be followed at all times
• Should a patient become suspect or positive for COVID-19 during embryo culture, a freeze-all policy should be adopted.
• Any laboratory spaces, biosafety cabinets, or incubators used for handling specimens from infected individuals should be
thoroughly decontaminated with a disinfectant approved for use against corona virus

77. LABORATORY
• Intensive washing of gametes and embryos is mandatory at all steps. ·
• Written protocols on maintenance of cryo-stored gametes and embryos, including liquid nitrogen
levels.
• For any ongoing cycles follow strict screening protocols
• Lab intensive disinfection in case urgent cycles to be done
• Cryopreserved specimen should be in separate tank during this period.
• No transfer of embryos/gametes between clinics to be done in this period

78. AC/ AHU/ Fans: operation gudelines
ICMR
The following process is recommended at start-up :
Open all the doors and windows of the space. Ensure that all cleaning protocols are
complete
Run the fresh air system at the maximum intake of air setting. Start and run the exhaust
systems if available.
Start the AC system in fan mode, without filters for minimum of 2-4 hours with doors
open and exhaust system operational. Install the clean & sanitized filters
Start the AC in normal mode and run for 2 hours with doors open and then close the
doors and windows.
The fresh air and ventilation system should be kept on throughout the off cycle
and on the weekend and holidays in air circulation mode.

80. Code of Conduct for staff and patients
All staff members and patients will be instructed to avoid unnecessary
exposure (both at work and in private).
• Each service will prepare compulsory instructions for staff
• Attendance at work will be tied to respecting the signed Code of
Conduct
• Activities that are not allowed will be clearly detailed (“Expose
yourself less” principle)

81. • Restricted social life and interactions
• Patients should sign regularly that they are well and have respected the
Code.
• Staff members should sign regularly that they are well and have
respected the Code or inform the centre's Person Responsible of any
infringements of the Code of Conduct previously signed.

82. PLEASE TELL US ABOUT TRAINING AND
RECIPROCAL AGREEMENTS

83. TRAININGMany centres are involved in training whether through
formal training programmes or local skills training
COVID-19 work patterns should not be a barrier to continuing to
support training in all areas of practice.
Physical distancing rules apply
Since changes in practice are likely to exist for some time this is an
important training period for both new and existing practitioners
and indeed, they may bring useful ideas and insights from
experience elsewhere.

84. RECIPROCAL AGREEMENTS
Contingencies should be in place to allow for unexpected staff reduction and centres should
investigate the feasibility of sharing staff across facilities.
the breadth and scope of reciprocal arrangements between centres should be reviewed, to
incorporate staffing, consumable provision and general support, where applicable and where
possible.
A caveat to increasing public freedoms is the risk of a “second wave” of infection.
Since the incidence of asymptomatic infection and population immunity can only be
estimated, the severity of a second wave and the effect on workplaces where staff have
previously been relatively protected should be considered.
In a staged resumption of treatments, centres need to take into account the potential for a
number of staff being sick or isolating at any one time. The volume and complexity of work
undertaken should be matched by an appropriate number of staff with the appropriate skill
mix.

85. What about PGT – A test? Are you
going to take a COVID19 specific
consent along with ICMR consents

86. • One publication which was a conversation on ASRM
website stated the PGT A cannot be done as they
cannot ensure enough precautions social distancing
with staff

87. 87

88. During the current shutdown how
to maintain your Lab

89. DURING SHUTDOWN
• SUPPLIES: Place consumables
and media orders on hold
• Perform inventory on stock to
determine the extent of
capable operations with the
amount in hand in case of
shortage of supplies
• MEDICAL GASES AND LIQUID
NITROGEN: Maintain regular
supplies
• Incubators and Other Lab
Equipments: If shut down
ensure it is clean and ready to
restart as required, can be left
on to minimise temp and gas
drift in this case ensure regular
check on gas reserves and
systems

91. Concluding Remarks

92. “SOMETIMES OUR LIVES HAVE TO BE COMPLETELY SHAKEN UP
CHANGED AND REARRANGED TO RELOCATE US TO THE PLACE
WE ARE MEANT TO BE”

93. Resuming services
• Maintain contact with patients whose treatment has been disrupted or deferred
• Prioritisation when services are able
to recommence.
• Ideally commencement when peak of
of the Epidemic subsides

94. CONCLUDING REMARKS
• Management of potential staffing and supply shortages
• Unintended exposure of staff members
• Additional cost burden
• Emergency plans and SOP to restart shd be made
• Informed consents
• SECOND WAVE : risk of reopening too quickly
• India’s R0 – 1.36 (as of May 4 2020 - news source)
La Marca Fert Stert 2020

95. • If we add costs of covid19 tests twice for both
husband and wife its approx 4500 x 4 that’s 18k per
case along with extra expenses for the PPE so cost is
a big factor
• The PPE could release VOC which could have an
effect on gametes
• Testing is not freely available in all areas

96. • Health being State subject no doubt the local Guidelines and our National
Association guidelines have to be followed
• Tell all patients before coming to clinic for first appointment to look up Courses on
WHO / Diksha app for Infection prevention control it only take an hour or so to do
these courses and get a certificate
• All doctors and staff members should also do it
• Rotate staff in shifts with one week off and on or 2 weeks off an on as quarantine
is 2 weeks if positive remember. (don’t extend the day and make staff come on
same day at different timings or do alternate days)
• Prepare a document for your own clinic with SOPs
• 15 minute gap between 2 appointments and 90 minute gap between ET and Egg
collection recommended as per HFEA Guidelines

97. • Prioritise Fertility preservation
• then
• Poseidon Group 4 and then group2/3
• Then
• Frozen transfers

98. Posieden criteria(Patient-OrientedStrategies Encompassing
Individualized Oocyte Number)

99. • THANK YOU