ASSISTED CONCEPTION POLICY 2013-2015 - Wandsworth CCG

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ASSISTED CONCEPTION POLICY2013-20151

Date approved:October 2013Date for review:April 2015Lead Director:Director of Commissioning & PlanningLead Manager:Interim Head of CommissioningNOTE: This is a CONTROLLED document. Any documents appearing in paperform are not controlled and should be checked against the server file versionprior to use.2

DOCUMENT CONTROL AND AMENDMENT RECORDAssisted Conception Policy 2013-2015VersionDate110/13Reason forreview/updateAuthor/ ReviewerRevised NICE guidanceA. Johnston3ApprovingCommittee(s)Date ofapproval

CONTENTS1INTRODUCTION1.1Purpose & Rationale1.2Aims 51.3Scope .52DEFINITION .53DUTIES 54ASSISTED CONCEPTION .54.1Unexplained fertility 54.2Types of infertility treatment .54.3Pathway and provider arrangements for assisted conception 64.4Commissioning policy 64.5Intrauterine insemination .74.6Pre-implantation genetic diagnosis .74.7Egg Donation 84.8Donor insemination .94.9Surrogacy .94.10Self funded patients . 104.11Invitro maturatin .104.12HIV infection and sperm washing .114.13Cryopreservation and cryostorage . 124.14Surgical sperm retrieval/recovery . 135.0DISSEMINATION . . 4513

Wandsworth CCG Assisted Conception Policy 2013 – 20151. INTRODUCTION1.1 Purpose / RationaleThis policy defines the Assisted Conception treatments offered in Wandsworthand the eligibility criteria for these treatments.1.2 Aims and ObjectivesThis 2013/2015 policy updates and replaces the 2012/2013 WandsworthAssisted Conception Policy.1.3 ScopeThis policy relates to Level 3 or specialist fertility services provided by tertiaryassisted conception units.Levels 1 and 2 fertility services are commissioned and provided in primary andsecondary care, and do not fall within the remit of this policy.This policy will ensure that all patients across Wandsworth who require assistedconception will be treated in accordance with Wandsworth CCGs commissioningprinciples.2. DEFINITIONTo access the tertiary fertility services described in this policy, preliminary advice,investigations and treatments, should have been completed at Level 1 and 2 asrecommended in the NICE Pathway - Fertility overview, and NICE Pathway onthe Investigation of fertility problems and management strategies.3.4.DUTIES It is the responsibility of the current providers of services to implement thePolicy. It is the responsibility of the CCG to review the policy as appropriate andupon the stipulated review date.ASSISTED CONCEPTION4.1 Unexplained infertilityWomen with unexplained infertility may be offered tertiary assisted conception ifthey have not conceived after two years of regular unprotected sexual intercourse(this can include up to one year before their fertility investigations), provided theymeet all the eligibility criteria outlined in Appendix 1.5

4.2 Types of infertility treatmentThere are three main types of infertility treatment – medical management (such as drugs for ovulation induction), surgical treatment (e.g. laparoscopy for endometrial ablation) assisted conceptionAssisted conception is a collective name for treatments designed to lead toconception by means other than sexual intercourse.Assisted conceptiontechniques include intrauterine insemination (IUI), in vitro fertilisation (IVF), donorinsemination (DI), intracytoplasmic sperm injection (ICSI) and cryopreservation(of sperm, oocytes and embryos).4.3 Pathway and provider arrangements for assisted conception (IUI, IVF,ICSI)In Vitro Fertilisation (IVF), Intra-Uterine Insemination (IUI) and IntracytoplasmicSperm Injection (ICSI) will normally be funded only in the context of the NICEfertility care pathway . See NICE Pathways - Fertility Overview.NHS Wandsworth has a single waiting list for assisted conception managed by StHelier. Patients can opt to receive treatment at St Helier/Kings or referral toanother assisted conception unit of their choice.4.4 Commissioning policyIn Vitro Fertilisation (IVF) / Intracytoplasmic sperm injection (ICSI):Definition:In Vitro Fertilisation (IVF) is a technique by which eggs are collected from awoman and fertilised with a man’s sperm outside the body. Usually one or tworesulting embryos are then transferred to the womb. If one of them attachessuccessfully, it results in a pregnancy.Intracytoplasmic sperm injection (ICSI) is a variation of IVF in which a singlesperm is injected into an egg.6

Embryo Transfer Policy statement: Wandsworth CCG will fund one (1) fresh cycle of IVF or ICSI for patientswho meet all of the criteria in Appendix 1. Where the couple produces more than one good quality embryo and havean elective single embryo transfer, the CCG will fund 12 months ofcryopreservation of the remaining embryos. If the initial embryo transferdoes not result in a live birth, the CCG will then fund a single unstimulatedfrozen embryo transfer.4.5 Intrauterine insemination (IUI)Definition:Intra-uterine insemination (IUI) is a technique to place sperm into a woman’swomb through the cervix.Policy statement:Wandsworth CCG will fund three (3) cycles of intrauterine insemination forcouples undergoing donor insemination for the following conditions: Obstructive and non-obstructive azoospermia (i.e. where the man hasno sperm in his semen) Severe deficits in semen quality Where there is a high risk of transmitting a genetic disorder to theoffspring Where there is high risk of transmitting an infectious disease from theman to the woman or to the offspring Severe rhesus isoimmunisation4.6 Pre-implantation genetic diagnosisDefinition:Pre-implantation genetic diagnosis can be used when one partner is known tohave the faulty gene. It involves having in-vitro fertilization (IVF) treatment, thengenetically testing the embryo in a laboratory to see if it has the faulty gene. Theembryo will only be placed inside the woman if it does not have the faulty gene.7

Policy statement:Wandsworth CCG will consider funding up to one fresh cycle of IVF or ICSI forcouples who have been recommended by the Pre-implantation GeneticDiagnosis (PGD) Clinical Advisory Group.RationaleThe Pre-implantation Genetic Diagnosis (PGD) Clinical Advisory Group has beenset up by the Genetics Consortium to consider individual requests for funding andmake recommendations to commissioners on the clinical appropriateness to fundindividual PGD cases.Couples wishing to access PGD will therefore not be treated in the same way ascouples requesting assisted conception. As such they will not be limited by therequirements of this policy (e.g. joining the centrally managed list, other aspectsof the clinical criteria). However, each case will need to receive specific priorapproval for funding from the CCG which will then act on the recommendations ofthe PGD Clinical Advisory Group. Funding for PGD does not fall within thefinancial allocation for assisted conception.4.7 Egg DonationDefinition:Egg donation is the process by which a fertile woman donates her eggs for use inthe treatment of other women or for use in research.Policy statementWandsworth CCG will fund one cycle of IVF/ICSI using egg/ovum donationfor women with: Premature ovarian failure Gonadal dysgenesis including Turner’s syndrome8

Bilateral oophorectomy Ovarian failure following chemotherapy of radiotherapy Certain cases of IVF treatment failureWomen must meet all of the criteria in Appendix 1Rationale:Some women cannot produce eggs, usually because their ovaries are notfunctioning, have been removed or they have a chromosomal abnormality.4.8 Donor inseminationDefinition:This form of treatment involves using sperm donated anonymously by anotherman.Policy statement:Wandsworth CCG will fund donor insemination using IUI for the followingconditions: Obstructive and non-obstructive azoospermia Severe deficits in semen quality in couples who do not wish toundergo ICSI Where there is a high risk of transmitting a genetic disorder to theoffspring Where there is high risk of transmitting an infectious disease from theman to the woman or to the offspring Severe rhesus isoimmunisation4.9 SurrogacyDefinition:Surrogacy is a way for a childless couple to become parents, with a surrogatemother carrying their child. In traditional surrogacy, the surrogate may be thechild's genetic mother i.e. her egg is fertilized using sperm from the man who9

wishes to raise the child. In gestational surrogacy, the pregnant woman is notbiologically related to the baby.Policy statementWandsworth CCG does not fund any element of surrogacy arrangements orassociated fertility treatments and procedures.Rationale:The funding of surrogacy arrangements and associated fertility treatmentsraises numerous legal and ethical issues which present significant risk tocommissioners.These risks arise from the complexities associated withsurrogate arrangements including: issues relating to the parentage of thechild; change of mind by any of the parties involved in the surrogatearrangement (including termination of pregnancy or refusal to surrender child);problems arising from “unwanted baby” or genetic or congenital defects.Given that these are either unresolved and that the legal position on many ofthese aspects are presently unclear, the legal advice to PCTs is not to fundany element of surrogacy procedures.4.10 Private/Self Funding PatientsPolicy statement Patients who are undergoing treatment outside of an NHS pathway will notbe funded or reimbursed for drugs or additional tests incurred as a result ofself funded/private treatment. The number of previous self-funded cycles of IVF/ICSI will be taken intoaccount in determining a patient’s eligibility for treatment (see Appendix 1)10

4.11In vitro maturationDefinition:In vitro maturation involves removing immature eggs that have yet to complete theirgrowth, and subsequently maturing these eggs in the laboratory.Policy statementIn vitro maturation will only be funded in exceptional circumstances.4.12HIV infection and sperm washingDefinition:Sperm washing is a process in which individual sperm are removed from the sementhen used in IUI or IVF. Its use in reducing male to female HIV transmission is basedon the observation that HIV is found in the seminal fluid rather than the sperm cells.Policy statementFunding of Sperm washing for the prevention of transmission HIV will be consideredon an individual patient basis.Rationale:Where the man is HIV positive, the risk of HIV transmission through unprotectedsexual intercourse is negligible when all of the following criteria are met: the man is complying with highly active antiretroviral therapy (HAART) the man has a plasma viral load of less than 50 copies/ml for more than sixmonths there are no other infections present unprotected intercourse is limited to the time of ovulationIf all of the criteria above are met, sperm washing may not further reduce the risk ofinfection and may actually reduce the likelihood of pregnancy. In addition, spermwashing reduces, but does not eliminate, the risk of HIV transmission11

4.13Cryopreservation and cryostorageDefinitionCryopreservation entails freezing of eggs, sperm and/or embryos that may bethawed for use in future IVF treatment cycles. Cryostorage entails storage of frozeneggs, sperm and/or embryos that may be thawed for use in future IVF treatmentcycles.Policy statementi) Wandsworth CCG will fund sperm cryostorage, egg cryostorage and embryocryostorage in the following circumstances: Medical or surgical treatment that is likely to have a permanent harmful effecton subsequent sperm or egg production. Such treatment includesradiotherapy or chemotherapy for malignant disease. Ongoing medical treatment that, whilst on treatment, causes harmful effectson sperm or egg production or has possible teratogenic effects, and in whomstopping treatment for a prolonged period of time to enable conception is notan option.ii) Commencement of cryostorage does not entitle people to assisted conceptiontreatments. There is the potential for individuals to meet the access criteria forcryostorage and not to meet the criteria for infertility treatments at a later date.iii)Storage: May not exceed five (5) years. Will not be available where a man or woman chooses to undergo medicalor surgical treatment whose primary purpose is infertility, such assterilisation; Will not be available where a man or woman requests cryostorage forpersonal lifestyle reasons, such as wishing to delay trying to conceiveiv)Post-storage TreatmentFunding of assisted conception treatments would be made available on thesame basis as other patients who have not undergone such storage12

RationaleCouples needing to access cryopreservation and cryostorage will not be treated inthe same way as couples requesting assisted conception. As such they will not belimited by the requirements of this policy (e.g. joining the centrally managed list,other aspects of the clinical criteria). However, each case will need to receivespecificpriorapprovalforfundingfrom WandsworthCCG.Fundingforcryopreservation and cryostorage does not fall within the financial allocation forassisted conception.4.14Surgical sperm retrieval/recoveryDefinition:Obtain sperm from the testicles in men who cannot ejaculate or have a blockage inthe flow of sperm from their testicles.Policy statementSurgical sperm retrieval will be commissioned in appropriately selected patientsprovided the obstructive azoospermia is not the result of a sterilisation procedure orthe absence of sperm and the couple meets all other criteria.RationaleSpermatozoa can be retrieved from both the epididymis and the testis using a varietyof techniques with the intention of achieving pregnancies for couples where the malepartner has obstructive or non-obstructive azoospermia. Sperm recovery is alsoused in ejaculatory failure and where only non- motile spermatozoa are present inthe ejaculate Surgically collected sperm in azoospermia are immature (because theyhave not traversed the epididymus) and have low fertilising ability with standard IVF.It is therefore necessary to use ICSI.5.0 DISSEMINATION AND IMPLEMENTATIONThe policy will be accessible through the CCG website and will be shared with GPpractices and acute organisations who carry out the procedure.13

References:1. NICE Clinical Guideline CG11 on Fertility 2004 (NB replaced by CG156)2. NICE Clinical Guideline CG156. Fertility: Assessment and treatment for peoplewith fertility problems,. February 20133. NHS Wolverhampton City Assisted Conception Policy4. NHS Surrey Assisted Conception Policy 20085. NHS Dorset, Bournemouth and Poole Fertility-Joint Assisted Conception Policy20106. NHS South Gloucestershire Policy statement on Surrogacy 20117. West Midlands Strategic Commissioning Group Surrogacy Policy 20128. NICE. Assessment and treatment for people with fertility problems UnderstandingNICE guidance – information for people with fertility problems, their partners andthe public 20049. National Collaborating Centre for Women’s and Children’s Health Fertility:assessment and treatment for people with fertility problems (update).Commissioned by NICE May 201214

Appendix 1: Wandsworth CCG Criteria for Access to tertiary Assisted Conception,including Intrauterine Insemination (IUI), In Vitro Fertilisation (IVF), IntracytoplasmicSperm Injection (ICSI)TitleDuration ofsubfertilityAge ofwoman atstart oftreatmentcycleBody massindex ofwomanSmokingstatus ofcouplePreviouscyclesChildlessnessCriteria Couples will be eligible for referral for treatment if they haveexperienced twenty four months of unexplained infertility* (thiscan include up to twelve months before their fertilityinvestigations) or have an identified cause of infertility Woman is aged 23 – 39 years at the time of treatment The lower age limit will not apply to women accessing treatmentdue to clinical care that is likely to result in long-term infertility Women aged 40 – 42 who have experienced twenty four monthsof unexplained infertility*, where the following criteria are fulfilled:o They have never previously had IVF treatmento There is no evidence of low ovarian reserveo There has been a discussion of the additionalimplications of IVF and pregnancy at this age2, 19 – 30 kg/m weight to be maintained for the last 6 months priorto application. Both partners should have been non-smokers for at least sixmonths prior to commencement of treatment. Couples will be eligible for NHS funding of one fresh cycle of IVFor ICSI. Where the couple produces more than one good qualityembryo and have an elective single embryo transfer, the CCGwill fund 12 months of cryopreservation of the remainingembryos. If the initial embryo transfer does not result in a livebirth, the CCG will then fund a single unstimulated frozen embryotransfer Where couples have self-funded previous cycles, these must notexceed TWO. Neither partner must have any living children from this orprevious relationships (including adopted children)Sterilisation Treatments will not be available if either partner has undergoneprevious sterilisation.HFEA Codeof PracticeCouples must comply to a Welfare of the Child assessment asdescribed in the Human Fertilisation and Embryology AuthorityCode of PracticeWomen insame sexcouples/ andwomen not ina partnership Sub fertility treatment will be funded for women in same sexcouples or women not in a partnership if those seeking treatmentare demonstrably sub fertile. In the case of women in same sex couples in which only onepartner is sub fertile, clinicians should discuss the possibility ofthe other partner receiving treatment before proceeding tointerventions involving the sub fertile partner. NHS funding will not be available for access to inseminationfacilities for fertile women who are part of a same sex partnershipor those not in a partnership. In circumstances in which women in a same sex partnership orindividuals are eligible for sub fertility treatment, the other criteriafor eligibility for sub fertility treatments will also apply. Women in same sex couples and women not in a partnershipshould have access to professional experts in reproductive15Rationale84% of women will conceive within one year ofregular unprotected sexual intercourse, thisincreases to 92% after 2 years and 93% after 3yearsThe likelihood of a live birth following assistedconception declines with age. Chances of livebirth per IVF cycle are: 20% for women aged 23-35 15% for women aged 36-38 10% for women aged 39 years 6% for women aged 40 years and overHigher body mass index reduces the probabilityof success associated with assisted conceptiontechniquesSmoking can adversely affect the success ratesof assisted reproductive techniques.The probability of a live birth following the IVF isconsistent for the first three cycles buteffectiveness of subsequent cycles is uncertain.As funding for assisted conception is limited,priority will be given to couples with the greatestneed.Sterilisation is offered as an irreversible methodof contraception and individuals on the NHS aremade aware of this at the time of the procedureHuman Fertilisation and Embryology (HFE) Act1990 (as amended) states:Section 13 (5): A woman shall not be providedwith treatment services unless account has beentaken of the welfare of any child who may beborn as a result of the treatment (including theneed of that child for supportive parenting), andof any other child who may be affected by thebirth.To ensure equality of access to the service.

TitleCriteriaRationalemedicine to obtain advice on the options available to enable themto proceed along this route if they

This policy defines the Assisted Conception treatments offered in Wandsworth and the eligibility criteria for these treatments. 1.2 Aims and Objectives This 2013/2015 policy updates and replaces the 2012/2013 Wandsworth Assisted Conception Policy. 1.3 Scope This policy relates to Leve

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