Title: Restart Fertility in Covid19
1Resumption 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
3KEY RECOMMENDATIONS-ASRM March 13 2020
- 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. - Strongly consider cancellation of all embryo
transfers whether fresh or frozen. - Continue to care for patients who are currently
in-cycle or who require urgent stimulation and
cryopreservation. - Suspend elective surgeries and non-urgent
diagnostic procedures. - Minimize in-person interactions and increase
utilization of telehealth.
4ART and COVID-19 ESHRE 2/4/20
European Society of Human Reproduction and
Embryology
- ESHRE advises that ART should not be started at
present for the following reasons - To avoid complications from ART/ potential SARS-Co
V-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 oncol
ogy patients, the cryopreservation of gametes,
embryos or tissue should still be considered.
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6India
Denmark restart 20/4/20
Australia IVFclinics restarted 21 to 27 April
2020
Sweden some clinics stayed open
Canada Restart as per local jurisdiction
Germany restart as per ESHRE
USA clinics some stayed open/ restarted
UK Restart May 2020 as per HFEA
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?
8COVID-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.
9Onder G JAMA 2020,Verity R Lancet Infec Dis 2020
9
10UNDERSTANDING BASICS
- Particles gt 5 to 10 micron called respiratory
droplets - lt 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)
11Where do we stand in the epidemic curve?
12Where do we stand in the epidemic curve?
13- Growth rate lt5 or Growth factor lt1 indicate
stabilisation and decline - Indias R vale (4/5/20 as per news updates)1.36
14Have we reached point of stabilisation?
- Many countries now reporting stabilisation of
infection - Australia
- Spain
- Italy
- China
- Germany
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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.
18Tell us about the Best practice guidelines for
reintroduction of routine fertility treatments
during the COVID-19 pandemic by ARCS and BFS
Date of publication 6th May 2020
19It 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.
20Guidelines updated 6/5/20
- The following 5 principles underpin the approach
taken in developing this guidance - 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. - Centres should ensure a fair and transparent
approach to any prioritisation policy.
21Five Key Principles
- Resumption should not result in an undue burden
on the NHS. - 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. - 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.
22ESHRE updated statement on restarting ART
23ESHRE 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.
24Resumption of ART
- 6 pillars of good medical practice
- Discussion, agreement and consent to the start of
treatment - Staff and patient triage
- Access to advice and treatment
- Adaptation of ART services
- Treatment cycle planning
- Code of Conduct for staff and patients
25HOW TO ENSURE PATIENT SAFETY
26Ensuring patient safety
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, ta
king 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 decis
ion whether or not to proceed with fertility treat
ment should be documented in the medical record.
27Patient 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
28HOW TO PRIORITISE PATIENTS
29Prioritisation
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
30ANY SPECIAL CAUTIONS for particular group of
patients
31Particular 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.
33TELL US ABOUT TRAIGING SCREENING BEFORE STARTING
TREATMENT
34Triaging, Screening and Testing
- Before starting treatment
- A screening questionnaire
- 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.
35Triaging 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 - Fever (feeling hot or temp gt37.5)
- 2. Persistent cough
- 3. Loss of the sense of smell
- 4. Loss of the sense of taste
- 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?
36Any difference between this and Eshre guidelines
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38Patients
- 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.
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40TRAIGING SCREENING DURING TREATMENT AND WHAT IF
TEST FOR COVID19 IS POSITIVE
41Triaging, 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. Consider
ation 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.
42Action 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.
43HOW TO REDUCE FACE TO FACE INTERACTION
Dr Poornima Durga
44Reducing 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. Recordi
ng 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.
45Reducing 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
46HOW TO MINIMISE CLINICAL RISK
47Minimising 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.
48Tell us about precautions for the staff will you
advise staff to do Covid19 test will you advise
staff to take HCQ prophylaxis?
49Staff
- 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
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51Adaptation of ART services
- Sanitation
- Staff and centre adaptation
- Access procedures
52- SANITATION/ DISINFECTION REARRANGEMENT OF
- CLINIC
53Sanitation
- 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.
54Disinfection
- 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 15 (v/v) dilution of bleach to
liquid biological waste is appropriate. - The contact time of these solutions should be at
least 30 minutes.
55VENUE 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 23 patients an hour, 2 h mopping
is recommended. - Hand sanitisation at entry
56Checking 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 6070
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
57TELL US MORE ABOUT STAFF AND CENTRE ADAPTATION
58Staff 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
59Access 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
62Precautions 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 6070 alcohol or a
1 sodium hypochlorite solution.
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65Equipment 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.
66TELL US ABOUT EGG COLLECTION AND ET PROCEDURE IN
COVID19 ERA
67TVS 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.
68Oocyte 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. - ExceptionPatients at risk of OHSS and fertility
preservation
69ART 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.
70Embryo 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 74Cryopreservation
- 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
76Laboratory
- 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
77LABORATORY
- 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
78AC/ 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.
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80Code 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.
82PLEASE TELL US ABOUT TRAINING AND RECIPROCAL
AGREEMENTS
83TRAINING
Many 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.
84RECIPROCAL 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.
85What 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
8787
88During the current shutdown how to maintain your
Lab
89DURING 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
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91Concluding Remarks
92SOMETIMES OUR LIVES HAVE TO BE COMPLETELY SHAKEN
UP CHANGED AND REARRANGED TO RELOCATE US TO THE
PLACE
WE ARE MEANT TO BE
93Resuming 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
94CONCLUDING 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
- Indias 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 thats 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. (dont 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
98Posieden criteria(Patient-OrientedStrategies
Encompassing Individualized Oocyte Number)
99