Sperm Processing and Cryopreservation

Module details

Title

Sperm Processing and Cryopreservation

Type

Specialist

Module code

SLS337

Credits

10

Requirement

Compulsory

Aim of this module

This module will provide trainees with the knowledge and understanding of the different reasons males seek fertility preservation, the principles and practice of cryopreservation and associated regulatory requirements.This module will consider the techniques of sperm processing and cryopreservation critically evaluating the principles, practices and risks alongside the evidence base to optimise the chance of having healthy offspring. The trainee will explore ethical and safety issues including patient, partners and family perspectives and what is required of a clinical scientist by the Health and Care Professions Council. They will understand and gain experience in sperm preparation and insemination methodologies. The trainees will also learn how to report results from freezing and thawing. Trainees should gain insight into patient perspectives and information sharing with patients and how well this is understood.

Competencies

#	Learning outcome	Competency	Action
# 1	Learning outcome 1,4,5,6	Competency Obtain consent from a range of patients referred to Andrology Services.	Action View
# 2	Learning outcome 2,3,4	Competency Maintain and select culture systems.	Action View
# 3	Learning outcome 1,3,4	Competency Perform and interpret swim-up techniques and density gradient separation of sperm samples of different quality, including: antisperm antibody-positive samples retrograde samples; severe oligoasthenozoospermic samples (for cryopreservation); frozen samples, including donor samples.	Action View
# 4	Learning outcome 2,3	Competency Label and perform witnessing prior to cryopreservation and following thawing/warming of semen.	Action View
# 5	Learning outcome 2,3,4	Competency Perform sperm cryopreservation Correctly use and handle liquid nitrogen and associated cryogenic equipment.	Action View
# 6	Learning outcome 2,3,4,5	Competency Thaw semen samples and compare pre-freeze and post-thaw parameters.	Action View
# 7	Learning outcome 2	Competency Release and receive cryopreserved gametes and embryos to other centres.	Action View
# 8	Learning outcome 2	Competency Fill and label a nitrogen shipping container.	Action View
# 9	Learning outcome 2,5	Competency Work safely in the laboratory to reduce the risk of transmission of infections, e.g. blood-borne viruses.	Action View

Assessments

You must complete:

• 2 case-based discussion(s)
• 2 of the following DOPS/ OCEs:

Prepare sperm from semen in compliance with relevant local practice by gradient and swim-up methods	DOPS
Culture prepared sperm and control media for 24h to assess aseptic preparation technique	DOPS
Perform QC checks within a cryofacility	DOPS
Perform slow freezing of sperm samples and review how method optimization may improve survival / sperm quality.	DOPS
Correctly complete HFEA consents for sperm storage and use with a patient	DOPS
Provide results of a sperm banking event to a patient / donor.	DOPS
Review a number of sets of case notes and recommend patient pathways including treatment options based upon these.	OCE
Present to the laboratory team a summary of the dangers of liquid nitrogen use and how to mitigate these.	OCE
Evaluate the potential effects on a potential sperm donor / banking patient of unexpected findings about their fertility, particularly with regard to azoospermia. Discuss with your team how these relate to best practice locally.	OCE

Learning outcomes

1. Review a set of case notes and recommend a patient’s pathway, including treatment options based upon clinical presentation.
2. Perform sperm preparation, cryopreservation and thawing, post thaw preparation within the statutory and regulatory framework.
3. Handle gametes correctly to maintain viability and perform different methods of sperm preparation techniques within the statutory and regulatory framework.
4. Perform quality control checks within the laboratory and the cryofacility.
5. Analyse key performance indicators with respect to defined outcomes then identify, troubleshoot and solve any problems.
6. Provide relevant information on results of banking attempts to patients / prospective donors.

Learning outcomes

1. Describe and critically evaluate the principles, practices and risks associated with sperm processing including strategies to reduce risk.
2. Critically review, discuss and evaluate the use of intra-cytoplasmic sperm injection versus other treatments for male infertility.
3. Explain the principles of the cryobiology of sperm, evaluating methods for freezing and thawing.
4. Discuss statutory and regulatory requirements for sperm processing and cryopreservation.
5. Justify professional codes of practice in relation to risk, scientific judgement and patient perspectives.
6. Discuss and debate the ethical and medical dimensions to fertility preservation.
7. Discuss the implications of consent anomalies.
8. Discuss the minimum and optimum requirements for operating an andrology cryofacility.
9. Analyse working practices to reduce the risk of transmission of infections, e.g. blood-borne viruses.

Indicative content

Sperm Processing

• Micromanipulation equipment and methodology
• Principles of intra-cytoplasmic sperm injection (ICSI) – (physical practice / performing is not required as this falls within Embryology).
• Risks and regulation associated with ICSI

 Intra-cytoplasmic sperm injection

• Indications
• Contraindications
• Procedure and different modalities (IMSI / PICSI)
• Risks
• Laboratory processes to optimise sperm location

 Cryobiology

• Cryobiology, including the physical and chemical processes occurring during cryopreservation and thawing
• Properties of cryoprotectants
• Handling of liquid nitrogen and the appropriate health and safety regulations and
• Thermodynamics of slow freezing and vitrification
• Physiological changes that occur in gametes and embryos during cryopreservation including the associated risks and strategies to reduce risk.

 Ethical, statutory and regulatory issues (sperm processing and cryopreservation)

• Regulatory issues with regard to cryostorage
• Counselling & breaking and managing bad news
• Safety, Audit and cryofacility operation
• Posthumous treatment
• Legal fatherhood
• Correct and incorrect completion of HFEA Consent forms, including background knowledge of example legal cases and
• Regulatory requirements for CE marked medical

 Ethical dimensions to fertility preservation

• Informed consent in special situations
• Patients undergoing treatments including:
• Chemotherapy
• Radiotherapy
• Life support
• Fertility preservation in high-risk occupations (e.g. military)
• Fertility [reservation as an option before gender-reassignment
• Fertility preservation in Pre-pubertal children, options and medical
• Posthumous treatment, individual, treated female, child and societal perspectives

 Analysis of Working Practices

• Effects for storage and fertility treatment for serodiscordant/concordant couples for HIV, HBV and
• Treatment and storage options for serodiscordant couples
• The importance of participation in training, supervision and mentoring

Activities

• Attend clinical appointments to gain experience of the clinical presentation of males requiring fertility preservation (with the permission of patients). Evaluate your experience in terms of both the clinical presentation and patient experience/needs and discuss with your supervisor.
• Visit at least two external referring-sites to review the different clinical settings experienced by patients attending the fertility preservation service. Reflect on your experience in terms of the differentiation between them and consider how this influences your future practice. Discuss the clinical effects with the team at these sites and evaluate with your supervisor.
• Visit an IVF laboratory (other than your own if you are based within one) and discuss their approach to sperm processing.
• Attend appointments at all stages (if possible) of the sperm donor pathway (with the permission of donors). Gain awareness of the processes faced by a sperm donor. Evaluate your experience in terms of both the clinical decisions and donor experience/needs with particular reference to requirements the donor may have for counselling. Discuss with your supervisor and the local BICA-accredited counsellor.
• Review patients’ notes where donated gametes have been used. Review and discuss the patient pathway, including why donor gametes were required, the counselling and consent process. Consider from both the specialist and patient perspectives.  All  of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding trainees must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome.
• Shadow a donor insemination pathway to gain awareness of the clinical situations in which the treatment is used, the monitoring undertaken and patient safety considerations (with the permission of patients where relevant).
• Participate in audits to gain experience of the statutory and regulatory requirements of cryopreservation, including the review of patients with stored material, consent checking, funding streams and any associated financial transactions. Reflect on the importance of audits to comply with regulation and to inform patients of their choices with respect to continued storage. The quality of the process and the importance/options/action.
• Select one case discussion and review in more detail, following patient/donor progress and actual/potential outcomes, to  include the clinical presentation, options considered, treatment provided and patient engagement and experience in the process.
• Compare advantages and disadvantages of electronic versus manual witnessing procedures, understanding their limitations and discuss your findings and conclusions with your supervisor.