2023-3-20 ART Updated Standard For Publication
2023-3-20 ART Updated Standard For Publication
2023-3-20 ART Updated Standard For Publication
It is the start date of deploying the standard and it may or may not match the
approval/publication date. The deployment start date must be discussed
Effective Date
based on finalizing all the needs necessary to implementation requirements
and the standard implementation plan.
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1. Standard Scope
1. Scope
1.1. This standard applies to DOH licensed fertilization centers and professionals licensed by DOH to provide
ART services; and
1.2. This standard aims to ensure the delivery of quality and safe clinical care for Assisted Reproductive
Technologies (ARTs) in the Emirate of Abu Dhabi by identifying:
1.2.1 Duties of providers of ART Services;
1.2.2 Licensure Requirements;
1.2.3 Quality Management System Requirements;
1.2.4 Quality Management System Requirements for Gametes Handling and Storage;
1.2.5 Patient Eligibility Criteria for ART treatment;
1.2.6 Data Reporting Requirements;
1.2.7 Patients Counselling and Information Requirements.
The ART cycle, which failed any stage for any reason before
2.6 Incomplete Cycle: oocyte or embryo freezing or embryo transfer.
1 WHO https://www.who.int/news-room/fact-sheets/detail/infertility
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A pharmacological treatment of women with anovulation or
oligo-ovulation with the intention of inducing normal
2.8 Ovulation induction: ovulatory cycles2. The maximum allowed trials per year of
ovulation induction with gonadotropins injections is six trials.
3.1.2 DOH Facility Licensure requirements to provide ART Services in the Emirate of Abu Dhabi
comprises of the following elements:
3.1.2.1 Satisfying the DOH requirements for healthcare facility and healthcare
professionals’ licensure;
3.1.2.2 Satisfying the federally mandated technical conditions and specifications as per
UAE Federal Law on Assisted Reproduction.
3.1.3 Fertilization Centers must satisfy the following accreditation requirements for licensure
3.1.3.1 New Fertilization Centers to have either the College of American Pathology
Reproduction accreditation or ISO accreditation or UK NEQAS accreditation of their
laboratories within (6 to 12) months of DOH licensure;
3.1.3.2 Existing Fertilization Centers to have either the College of American Pathology or ISO
accreditation or UK NEQAS accreditation within (6 to 12) months of issuance of this
Standard.
2
https://www.who.int/reproductivehealth/publications/infertility/art_terminology.pdf
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https://www.who.int/reproductivehealth/publications/infertility/art_terminology.pdf
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3.2.2.2 Both husband and wife have consented for ART treatment;
3.2.2.3 Both husband and wife commit to undertake the necessary follow up by an ART
Consultant/Specialist.
3.2.2 Where patients do not meet the eligibility criteria, clinicians at the Fertilization Centers
must ensure patients are given adequate information on the reasons and clinical decisions.
This must also be documented in the patients’ medical file;
3.2.3 Women with significant obstetrical/surgical/medical problems e.g. diabetes making them
high risk at pregnancy/delivery would be offered Fertility/ART treatment only after
appropriate pre-conception counselling of the couple.
3.3.2 Fertilization Centers should comply with the requirements of patient informed consent
ensuring that patients have all the required information for each stage of the intervention
explained and document the patients’ consent and as per the federal law.
3.3.3 The Fertilization Center must ensure that couples seeking fertility treatment be provided
with clear information on:
3.3.3.1 Diagnosis and management options;
3.3.3.2 The associated risks mentioned in Appendix 1;
3.3.3.3 The likelihood of successful pregnancy;
3.3.3.4 The treatment-associated procedures and their risks and benefits including
required tests;
3.3.3.5 The need for treatment and care pre and post interventions;
3.3.3.6 Couples suitability for ART intervention and the likelihood of its success and
Predicted Success Rates;
3.3.3.7 Risk of cycle cancellation due to no response or over response to ovarian
stimulation;
3.3.3.8 Risk of multiple pregnancies and the associated morbidity to the mother and
unborn children;
3.3.3.9 Informed of any procedures that are likely to affect their fertility and the option
to preserve the sperm and/or unfertilized ova by freezing must be offered;
3.3.3.10 Offered the information leaflets specified above in Arabic and English.
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3.3.6 Consent must be undertaken at each decision-making point (treatment and/or storage) and must
be clearly documented by the treating physician in the patient’s notes. Evidence of the
patient’s/couple’s written consent must also be documented:
3.3.6.1 Separate “Consent for Treatment” must be obtained for the following:
3.3.6.1.1 Consent to undergo ART treatment and treatment type (couples);
3.3.6.1.2 Consent from the wife to use her eggs for her treatment;
3.3.6.1.3 Consent to use the husband’s sperm for his wife;
3.3.6.1.4 Couples consent to transfer the embryo(s) into the uterus or fallopian tube.
3.3.6.2 Separate consent for Storage must be obtained for the following and as per section 6
including:
3.3.6.2.1 Consent to the storage of the female’s eggs;
3.3.6.2.2 Consent to the storage of the male’s sperm;
3.3.6.2.3 Consent to use male’s sperm following storage;
3.3.6.2.4 Consent to use the female’s eggs following storage;
3.3.6.2.5 Consent to extend the storage of the male’s/husband’s sperm in line with the
UAE Federal Law on Medically Assisted Reproduction;
3.3.6.2.6 Consent to extend the storage of the unfertilized eggs in line with the UAE
Federal Law on Medically Assisted Reproduction.
3.4.2 Providers are required to present evidence to DOH, when requested, on achieving
quality and safety through records on the number of ICSI cases performed per licensed
embryologist per day, and demonstrate that these are comparable to international
evidence based best practice.
3.4.3 Ensure compliance with the DOH reporting requirements, including Jawda KPIs for ART
and serious untoward incidents associated with ART treatments mentioned in
Appendix 1 in addition to the requirements for DOH Standard for Adverse Events
Management and Reporting in the Emirate of Abu Dhabi and DOH Standard for
Reporting Adverse Reactions;
3.4.4 Report and submit e-Claims data in accordance with the Chapter on Data
Management, Healthcare Regulator Manual Version 1.0 and as set out in the DOH Data
Standards and Procedures.
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4. Key Stakeholder Roles and Responsibilities
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4.1.7.1 Comply with DOH requests to inspect and audit records and cooperate with DOH
authorized auditors, as required for inspections and audits by DOH.
4.2 Specific Duties of Healthcare Providers providing ART Services - Fertilization Centers:
Fertilization Centers should develop:
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4.2.2.5 Ensure that the storage facilities for gametes:
4.2.2.5.1 Are dedicated for the purpose, and adequate for the volume and types of
activities;
4.2.2.5.2 Are designed to avoid proximity to ionizing radiation (radioactive material),
any known potential source of infection, or chemical or atmospheric
contamination;
4.2.2.5.3 Have a storage-location system that minimizes the amount of handling
required to retrieve gametes;
4.2.2.5.4 Have a system in place for specimen tracing to ensure proper gamete
handling and identification;
4.2.2.5.5 Have emergency management procedures to deal with damage to storage
vessels, failure of storage conditions or both.
4.2.2.6 Ensure that gametes are packaged for storage in a way that:
4.2.2.6.1 Prevents any adverse effects on the material;
4.2.2.6.2 Minimizes the risk of contamination.
4.2.2.7 Ensure that proper risk assessments (approved by the director of the ART facility) are done to
determine the fate of all stored material whenever any of the following is introduced:
4.2.2.7.1 A new processing step to enhance safety, quality or both; and
4.2.2.7.2 A new procedure for appropriate disposal of gametes.
4.2.2.8 Ensure the safety of equipment used to store cryopreserved gametes by:
4.2.2.8.1 Storing gametes in a designated area where access to this area must be
limited to authorized staff;
4.2.2.8.2 Ensuring that Cryopreservation Dewars should be fitted with local alarms and
be linked to an auto-dial or similar facility, (e.g. a link to a fire alarm board) to
alert staff to non-conformities outside normal working hours;
4.2.2.8.3 Having adequate number of staff for an ‘on-call’ system to respond to alarms
during out-of-office hours, and adequate spare storage capacity to enable
transfer of samples if a Dewar fails.
4.2.2.9 Divide individual patients’ samples into separate storage vessels for those patients whose
future fertility may be impaired by a medical condition or procedure. This is important in the
case of Dewar failure.
4.2.2.10 Establish documented procedures to ensure that reviews of stored gametes are conducted at
least once every year to:
4.2.2.10.1 Reconcile the Center’s records with the material in storage;
4.2.2.10.2 Review the purpose and duration of storage; and
4.2.2.10.3 Identify any action needed.
4.2.2.11 Ensure the following with respect to storage of gametes and related information provided
to patients:
4.2.2.11.1 That they operate a bring-forward system in order to ensure sufficient
advance notice of the end of the statutory storage period (or such shorter
period as specified by a person who provided the gametes) for gametes in
storage;
4.2.2.11.2 If one of the gamete providers withdraws consent to the continued storage
of gametes intended for treatment (created from their gametes), the Center
must notify both recipient(s) prior to disposal;
4.2.2.11.3 Not store gametes after the expiry of the legal storage period identified in the
UAE federal law, or the period specified when the gametes were stored, if
shorter;
4.2.2.11.4 Explain to gamete providers and current patients the importance of informing
the center of any change in their contact details and document their efforts
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to stay in contact with patients who have gametes in storage for their own
treatment;
4.2.2.11.5 Inform patients who have gametes in storage for their own treatment when
the end of the permitted storage period is approaching and inform them of
the options available to them. Patients should be given enough notice to
enable them to consider those options, and to access appropriate advice;
4.2.2.11.6 Obtain written consent from both husband and wife prior to the disposal of
gametes;
4.2.2.11.7 Comply with the UAE Federal Law Concerning the Licensing of Fertilization
Centers in the State in disposing of the gametes when the period of storage
is finished for couples that they lost;
4.2.2.11.8 Clearly explain the Federal UAE Law on Medically Assisted Reproduction and
its implementing regulation to all patients before starting the ART treatment
with clear documentation of the same especially for cases of unreachable
couples.
This standard has clear monitoring mechanisms in place for assessing its success factors and outcomes.
6.1 Fertilization centers providers, payer and TPAs, must comply with law, the terms and requirements of this
Standard, the DOH Standard Provider Contract and the DOH Data Standards and Procedures.
6.2 DOH may impose sanctions in relation to any breach of requirements under this standard in accordance
with the Chapter on Complaints, Investigations, Regulatory Action and Sanctions, Healthcare Regulator
Manual: (https://www.haad.ae/haad/tabid/1276/Default.aspx).
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7. Relevant Reference Documents
Reference Reference
No. Relation Explanation / Coding / Publication Links
Date Name
8th Nov 2022 Appendix 2, Exemption to the lower age limit for cancer patients
Item 9
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9. Appendices
Patient Data:
1) Patient ID
2) Date of referral
3) Source of referral and referrers/clinicians’ details
4) Patient Date of Birth
5) Patient Address
6) Date(s) of egg collection
8) Date of frozen cycle (where appropriate)
9) Patient Outcome(s)
10) Prognosis
11) Additional comments (Description of condition)
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Appendix 2: Principles of Care for the Provision of ART Services in Abu Dhabi Emirate
1. Treatment a) The treating physician should take account of potential adverse obstetric outcomes and
complications, such as early pregnancy failure, ovarian hyper stimulation syndrome, and
neonatal complications when providing ART and must explain these potential adverse
events to the couple seeking the treatment;
b) In line with DOH Policy on Quality, investigations and interventions should be based on
the latest evidence and guidelines;
c) The most effective and least risk associated procedure should always be offered as a
first line treatment option; and
d) Infertility may be diagnosed prior to one year if there are features or findings indicative
of subfertility. These include:
I. Oligo or amenorrhea;
II. Inability to have intercourse due to a medical condition;
III. Previous adjuvant therapy for cancer in either partner;
IV. History indicating an increased risk of Fallopian tube occlusion (i.e. previous pelvic
infection or previous pelvic surgery);
V. Abnormality in one or more semen parameters as an indication of male factor
infertility (normal semen as: volume ≥1.5 ml; pH ≥7.2; sperm concentration ≥15
million spermatozoa/ml; total sperm number: ≥39 million spermatozoa per
ejaculate; total motility ≥40% motile, or ≥32% with progressive motility; vitality:
≥58% live spermatozoa; percentage of sperm with normal morphology ≥4%));
VI. Reduced ovarian reserve;
VII. Identified high-risk patients should be treated by consultants.
2. Ovarian a) Where the risk of ovarian hyper-stimulation is high, a risk assessment should be
Hyper- undertaken before treatment starts and women identified to be at risk must have a clear
stimulation treatment plan that outlines the risk reduction strategies.
3. Allowed a) For patients undergoing an embryo transfer procedure, single embryo transfer should
number of be the preferred choice (Appendix 3). However, depending on the quality of the
transferred embryos and the clinical judgement of the physician, double embryo transfer could be
embryos an alternative, if deemed necessary to improve the chance of a pregnancy.
4. Ovarian a) Usage of Ovarian Induction Drugs in the Emirate of Abu Dhabi should be limited to DOH
Induction licensed Reproductive Endocrinologists/ IVF Specialists and Consultants.
Drugs
5. Procedures a) All ART related procedures, including monitoring, intrauterine inseminations, oocyte
retrievals, embryo transfer procedures should be only performed by DOH licensed
Reproductive Endocrinologists/ IVF Specialists and Consultants.
6. ICSI a) Laboratories licensed by DOH should have in place written procedures approved by the
nominated Director to manage the ICSI cases and ensure quality and patient safety are
prioritized.
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7. Clinical Treatment Phase Patient Investigations
Investigations
for ART
Treatment UAE Federal Requirements prior Female and Male HIV (I and II), Hepatitis B
to handling of gametes for ART (Antigen / Antibody) and
Hepatitis C Antibody
Recommended Baseline Female Blood type, Rhesus Factor
Investigations CBC
(To establish the diagnosis of High Vaginal Swab, Syphilis,
infertility or to plan for the ART
treatment) Chlamydia and Gonorrhea
Rubella IgG
Pap / Cervical smear
TSH, Prolactin, AMH, FSH,
LH, Estradiol, Vitamin D
Transvaginal ultrasound
Male Blood type, Rhesus Factor
Semen
analysis,
Syphilis
ART cycle - Investigations Female Estradiol, LH, FSH,
Progesterone
Ultrasound (Transvaginal or
perineal or rectal or
abdominal)
Coagulation tests (PT, PTT
and INR before each oocyte
pickup (OPU))
8. Genetic a) Fertilization centers should comply with the UAE federal law on genetic testing.
Investigations
9. Women’s Age a) The preferred age range for women seeking fertility is between 18-47* years
and Body (completed years i.e. 18 years 0 days till less than 48 years 0 days). *For women aged
Mass Index 46 to 47 years (completed years i.e. from 46 years 0 days till less than 48 years 0 days),
(BMI) ART treatment could be considered if the AFC (antral follicle count only if done by a
fertility expert) is equal to or above 5 (as per ESHRE Bologna criteria)
b) There is an exception to the lower age limit for fertility preservation (cryopreservation)
in female patients diagnosed with cancer.
b.1. The patient could be less than 18 years of age.
b.2. Patient must have reached reproductive age (post-pubertal sexual maturity)
b.3. A person whose age is less than 18 years opting for ART treatment must have a
substitute consent giver to sign on the application or request for the treatment.
b.4. Oncologist-approved fertility preservation documentation.
b.5. The following referral pathway must be established.
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c.1.1. Informed of the increased risk of failure in fertility treatment and risk to
pregnancy and child as a direct result of their physical condition; and
c.1.2. Advised to consult a registered dietitian for weight management
intervention for minimum of three months.
Appendix 3: Contraindications for dual embryo transfer. (*Refer to Appendix 2 clause number 3)
The treating clinician can consider these conditions and decide after complete clinical assessment including
medical history, family history and investigations.
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