What protocol should be followed at an assisted reproductive technology (ART) centre in India?

Protocol for ART Centre Operations in India

All ART centres in India must implement a comprehensive triage-based protocol with mandatory patient and staff screening, strict laboratory safety standards, and robust traceability systems to ensure optimal clinical outcomes while minimizing risks. 1, 2

Staff Management and Triage

Staff Screening Requirements

• All staff members must complete triage questionnaires 15 days before starting work and undergo regular re-triage based on local disease prevalence 1
• Staff testing positive for infectious diseases (IgM antibodies and/or PCR) must undergo self-quarantine with documented clearance required before resuming work 1
• Symptomatic staff must immediately notify the centre, undergo testing, and be isolated pending results 1
• Create mini-teams to ensure treatment continuity and reduce unnecessary exposure 1

Staffing Qualifications

The centre must employ personnel with appropriate academic credentials, continuing education, and structured competency assessments 3. This is critical in the Indian context where standardization of training varies significantly across centres 2.

Patient Triage and Management

Pre-Treatment Screening (2 Weeks Before Treatment)

Both partners must complete detailed triage questionnaires covering:

• Clinical history and current symptoms
• Lifestyle factors and potential exposures
• Contact with potentially infected individuals
• Any changes must be immediately reported to the centre 1

Three-Scenario Triage System

Scenario 1 - Low Risk (Proceed with Treatment):

• Both partners asymptomatic
• Negative clinical history
• No contact with potentially infected people
• Standard procedures apply 1

Scenario 2 - Intermediate Risk (Conditional Treatment):

• Patients recovered from previous infections requiring clearance evidence and IgM/IgG testing 1
• If symptoms develop before ovarian stimulation: repeat triage at stimulation start
• If symptoms develop during stimulation: perform diagnostic testing immediately
• Continue treatment only if testing is negative; postpone if positive 1

Scenario 3 - High Risk (Postpone Treatment):

• Either partner symptomatic
• Positive IgM or RT-PCR test results
• Treatment must be postponed immediately
• Positive patients referred to dedicated services per local/national guidance 1

Special Populations

• Patients with severe previous COVID-19 requiring ventilation: Assess respiratory function before proceeding due to permanent lung impairment risk 1
• Patients with systemic pathologies (diabetes, hypertension, heart/lung/liver/kidney disease, immunosuppressant therapy): Refer for expert assessment before treatment 1

Facility Organization and Safety

Physical Infrastructure

• Reorganize to ensure social distancing throughout the facility 1
• Redesign waiting areas with protective screens for administrative staff 1
• Implement ISO cleanroom standards for laboratory areas 3
• Establish BSL-2 compliance with proper risk zoning 3

Infection Control Measures

• Routine sanitation of all areas with specific COVID-19 protocols for positive cases 1
• PPE and sanitation devices available for all patients and staff 1
• Staff must use appropriate PPE at all times 1
• Proper waste disposal systems in place 3

Access Control

• Limit simultaneous occupancy through scheduled appointments 1
• Restrict accompanying persons (including partners when not strictly necessary) 1
• Screen all individuals entering the facility (staff, patients, cleaners, contractors) 1

Treatment Cycle Management

Ovarian Stimulation Monitoring

• Minimize in-person visits: Limit ultrasounds and blood tests to 2-3 assessments (at down-regulation, during stimulation, and trigger day) unless clinically indicated 1
• Use telemedicine for follow-up advice and information whenever possible 1
• Streamline appointments to reduce waiting time and facilitate social distancing 1
• Maintain strict hygiene protocols for ultrasound equipment and consultation rooms 1

Oocyte Retrieval Protocols

• Scenario 1 patients: Standard procedures unless symptoms arise between trigger and retrieval 1
• Scenario 2 patients: Perform IgM/IgG or RT-PCR testing; decision to continue based on results 1
• Scenario 3 patients: Immediately postpone treatment before ovulation triggering or embryo thawing 1
• Exceptional cases (high OHSS risk, medical fertility preservation): Retrieval may proceed with enhanced transmission-reduction procedures 1

Laboratory Standards and Safety

Sample Handling

• Adhere to established good laboratory practice guidelines 1
• Native follicular fluid and seminal plasma must be diluted and safely disposed in individual closed containers 1
• Exercise extra caution to avoid potential viral infections through follicular fluid and semen processing 1

Cryopreservation Protocols

• If patient becomes positive after oocyte retrieval: Cryopreserve all oocytes/embryos using high-security straws and/or vapour phase storage tanks 1
• Cryopreserve one embryo per device to facilitate SET practice and ensure traceability 4
• Implement robust traceability systems for all biological material 2, 3

Embryo Transfer

• Perform only in low-risk, asymptomatic couples 1
• Partners not allowed in operating theatre during transfer 1
• Practice eSET (elective single embryo transfer) as standard to minimize multiple pregnancy risks 4

Patient and Tissue Identification

Critical Identification Steps

Every procedure must include:

• Two unique identifiers verified by at least two persons 5
• Active use of procedure-specific checklists 5
• Clear protocols detailing identification methods and identifier sources 5
• Immediate notification procedures if identification discrepancies occur 5

Documentation and Traceability

• Track all clinical and laboratory stages using electronic platforms 3
• Implement witnessing systems throughout the ART process 3
• Maintain comprehensive documentation for regulatory compliance 3
• Ensure gamete traceability from collection through disposal or transfer 2

Post-Treatment Follow-Up

Mandatory follow-up 3 weeks after oocyte retrieval/embryo transfer regardless of pregnancy outcome to:

• Check patient health status
• Identify potential positive cases
• Activate contact tracing measures if post-treatment positive case diagnosed 1

Patient Education and Consent

Required Information Disclosure

• Full explanation of risk reduction measures and treatment information 1
• Balance between risks and benefits of treatment postponement 1
• COVID-19 symptoms, transmission routes, and implications 1
• Treatment discontinuation if risk status changes from low to high 1
• Cost-related information discussed at treatment planning stage 4

Code of Conduct

Patients must acknowledge:

• Moral obligation to immediately inform staff of status changes or symptom development 1
• Awareness for relatives/friends about infection risks to treatment 1
• Understanding that treatment is at patient request and can be postponed for personal reasons 1

Quality Management and Performance Monitoring

Key Performance Indicators

Monitor and benchmark:

• Fertilization rates
• Blastocyst formation rates
• Cryosurvival rates
• Clinical pregnancy and live birth rates 3

Equipment Validation

• Regular validation of incubators and cryogenic tanks given direct impact on embryo development 3
• Environmental monitoring systems in place 3
• Maintenance schedules strictly followed 3

Emergency Preparedness

Establish agreements between ART centres for management of potential emergency closures to avoid treatment discontinuation 1. This is particularly important in India where geographic disparities in access exist 6.

Common Pitfalls to Avoid

• Do not rely solely on oropharyngeal swabs - nasopharyngeal swabs have significantly higher detection rates (73.1% of NP-positive cases were OP-negative) 1
• Do not base DET decisions on: number of previous unsuccessful treatments, duration of infertility, previous pregnancies/live births, or endometrial characteristics 4
• Never transfer more than two embryos due to higher-order pregnancy risks 4
• Do not prescribe testosterone monotherapy to males interested in current or future fertility 7

This protocol framework, while influenced by COVID-19-era guidelines [1-1], establishes fundamental safety and quality standards applicable to ongoing ART centre operations in India, addressing the documented need for standardization and ethical practice in the rapidly expanding Indian ART sector 2, 8, 9.