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From: TSS ()
Subject: New guidelines were published to screen sperm, egg and embryo donors for disease
Date: January 11, 2009 at 9:16 am PST

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----- Original Message ----- From: TERRY SINGELTARY To: TERRY SINGELTARY Sent: Thursday, January 08, 2009 8:16 PM Subject: New guidelines were published to screen sperm, egg and embryo donors for disease

Last Modified: 09 Jan 2009 Source: PA News

New guidelines were published to screen sperm, egg and embryo donors for disease.

The guide includes new rules to cut down the risk of passing on the human form of mad cow disease, Creutzfeldt-Jakob disease (CJD).

Although there are no current tests to predict if people are at risk of developing CJD, donors should not be accepted if either they or a close family member has been diagnosed with a prion-related disease such as CJD. The new guidelines update ones published by the British Andrology Society in 1999 and by the British Fertility Society in 2000.

Anyone who has undergone invasive neurosurgery or received human pituitary-derived growth hormone should also not be accepted as a donor.

Those who have had a tissue transplant from the human eye or nervous system will also be rejected to cut down down the risk of passing on CJD.

The guide is intended to update medical professionals with the latest techniques in one single document.

Screening rules related to diseases such as HIV, hepatitis B and C, syphilis, gonorrhoea and chlamydia remain the same. So do those for screening for genetic diseases. Recommended upper age limits for donors also remain the same - 35 for women and 40 for men.

Dr Allan Pacey, chair of the working party that developed the guidelines, said: "The donation of sperm, eggs and embryos is a key aspect of assisted reproduction and many couples rely on donors to create a family.

"These guidelines aim to reinforce the safety of donation both for the recipient and for donor-conceived people. The UK professional bodies have worked together to revise these guidelines and promote good clinical practice, providing patients with safe and effective treatment and helping them have healthy children."

The guidelines were produced by a group comprising representatives from the Association of Biomedical Andrologists, Association of Clinical Embryologists, British Andrology Society, British Fertility Society and the Royal College of Obstetricians and Gynaecologists.

http://www.channel4.com/news/articles/society/health/new+screening+for+fertility+donors/2900117

British Fertility Society calls for national infrastructure to improve sperm donor recruitment in the UK 12 November 2008

The British Fertility Society (BFS) has issued new recommendations to address the critical shortage of sperm donors in the UK. In a report published in the journal Human Fertility, the BFS calls on the Department of Health to assist the sector in implementing a nationally co-ordinated strategy to improve the donor recruitment infrastructure across the country.

In 2007 the BFS convened a working party, including representatives from the Donor Conception Network, Infertility Network UK and the National Gamete Donation Trust, to address key issues relating to the national provision of sperm donation services and recommend new proposals to increase donor numbers and therefore allow more patients to be treated. The review reveals that the current national shortage of sperm donors is at a critical level, with only a small proportion of UK fertility clinics having the resources to recruit new donors. Figures from the Human Fertilisation and Embryology Authority show that fewer patients received treatment with donor sperm in 2006 than any year previously recorded. The working party concluded the demand for donor insemination (DI) in the UK is approximately 4000 patients per year, which would require at least 500 sperm donors to be recruited each year. In 2006, there were only 307 newly registered donors, 40% lower than the number registered in 19911.

The report recommends a national framework of sperm donation services should be implemented, based on a 'hub and spoke' model. Under this plan, main regional 'hub' centres would coordinate and implement the majority of services for donors, such as recruitment, screening tests, sample storage, and counselling, with smaller local 'spoke' centres providing services for patients requiring treatment, such as counselling, medical assessment and treatment with donor sperm. According to current demand for DI, the report proposes that 14 main 'hub' centres should be set up across the UK. These main centres would also be responsible for regulating family numbers per donor, and delivering sperm samples across the country. This proposed service plan is designed to increase the efficiency of donor recruitment and management, particularly during the early stages of the process between the initial enquiry and first attendance at a clinic where up to 35% of potential donors are currently lost. It will also allow donation services to be evenly spread across the country, allowing greater accessibility and improved public awareness.

Additional key recommendations of the report: The number of families allowed to be created by a single donor (currently 10) should be re-evaluated and flexible in approach. The working party call for further research in this area to assess the impact of any policy changes on donors, their current children, and donor-conceived children and adults. More research into 'sperm sharing schemes' is needed to increase donor availability. Such schemes allow male partners of women seeking fertility treatment to donate sperm for DI, which in turn reduces the cost of their IVF treatment. Better counselling facilities should be offered by clinics to known donors and their recipients. There is currently inconsistency among clinics on policy in this area. The current thresholds for acceptable sperm quality and the maximum age limit of male donors should remain unchanged, so as not to compromise safety standards. Patients should be given the option of choosing donors with similar physical characteristics to themselves, such as stature, hair or eye colour. Dr Mark Hamilton, Chair of the Working Party and Chair of the British Fertility Society said: "The British Fertility Society believes a nationally co-ordinated approach to the organisation of sperm donation services is essential to improve donor numbers. Sperm donation is a key aspect of assisted reproductive therapy and many couples rely on donors to create a family. However, the number of sperm donors has been steadily declining over the past 15 years, and only a minority of fertility clinics now have the infrastructure to recruit new sperm donors. The "hub and spoke? model we have proposed will allow regional centres to deal with the initial management of donors, a point at which many donors are currently lost. With main regional centres focussing on donor management, this will allow local centres to concentrate their resources on recipient services, which should significantly reduce costs. The British Fertility Society now calls on the Department of Health to assist the sector in the implementation of a centrally co-ordinated strategy to address this significant area of health care provision which is currently inadequate to meet current and future service needs."

Walter Merricks, Chair of the Donor Conception Network said: "We applaud the initiative taken by the BFS to bring clinics together to cooperate on a national basis in the task of sperm donor recruitment. Recruiting sperm donors needs determination, investment and special skills, and it makes sense that the task should be shared. The currentshortage means that many of those seeking donor insemination treatment are going to clinics overseas. The vast majority of our members would far prefer to be treated locally with a UK donor under the protections afforded by HFEA regulation. We urge all clinics to cooperate in this important initiative."

Clare Lewis-Jones, Chief Executive of Infertility Network UK said: "We know from the calls we receive from patients needing donor insemination how devastating it is to not be able to access the treatment they need in order to have a family because of the current shortage of sperm donors which in some cases is simply because of where they live. We congratulate the British Fertility Society and our colleagues on the working party on their report and endorse their recommendations. We hope that this initiative will help make a difference in the lives of those needing sperm donation."

Laura Witjens, Chair of the National Gamete Donation Trust said: "It is of great concern to the National Gamete Donation Trust that current inefficiencies and inconsistencies in sperm donor recruitment and management mean that patients are not given the best chance. Our experience is that dedicated potential sperm donors are lost on a regular basis because of insufficient care or lack of access.

The implementation of a national framework of sperm donation services, as recommended by the BFS and the Working Party, could potentially increase the number of sperm donors by 35%. In combination with regular public awareness campaigns, this bold proposal may well bring an end to sperm donor shortages in the UK.

We welcome the recommendations of the BFS and the Working Party and applaud them for their vision. The NGDT now calls on the Department of Health and the sector to support this proposal so both donors and patients receive better and more consistent care throughout the UK."

General information The Working Party on Sperm Donation Services in the UK was chaired by Dr Mark Hamilton, Chair of the British Fertility Society. The group included representatives from the patient group Infertility Network UK, the National Gamete Donation Trust, and Donor Conception Network. Members of the Department of Health and Human Fertilisation and Embryology Authority were also in attendance. The findings of this report are also presented as an editorial in this week's British Medical Journal (2008:337:a2318). The British Fertility Society is committed to promoting good clinical practice and working with patients to provide safe and effective fertility treatment.

--------------------------------------------------------------------------------

Notes for Editors For more information, please contact the British Fertility Society Press Office

This report is published in Human Fertility 2008, 11(3), 147-158. DOI: 10.1080/14647270802170174. A full copy of the report is available here. Human Fertility is the official journal of the British Fertility Society. The findings of this report are also presented as an editorial in this week's British Medical Journal, 2008; 337: a2318.

The British Fertility Society is a national multidisciplinary organisation representing professionals practising in the field of reproductive medicine.

Donor Conception Network are a self-help network of families created with the help of donated eggs, sperm or embryos, people seeking to found a family this way and adults conceived using a donor. For more information, visit http://www.dcnetwork.org

Infertility Network UK are the UK's leading infertility support network. They offer information and support to anyone affected by fertility problems and campaign to improve awareness and access to treatment. For more information, visit http://www.infertilitynetworkuk.com/

The National Gamete Donation Trust provides clear and practical information for those considering becoming an egg or sperm donor but also for health professionals and those requiring treatment with donor eggs or sperm. For more information, visit http://www.ngdt.co.uk/

1 HFEA. 2007. Facts and figures. http://www.hfea.gov.uk/en/1459.html

http://www.britishfertilitysociety.org.uk/news/pressrelease/08_11-DonorRecruitment.html

Risks of transmission of spongiform encephalopathies by reproductive technologies in domesticated ruminants

References and further reading may be available for this article. To view references and further reading you must purchase this article.

A. E. Wrathall

Veterinary Laboratories Agency (Weybridge), New Haw, Addlestone, Surrey KT15 3NB, UK

Available online 7 February 2000.

Abstract This paper considers whether transmissible spongiform encephalopathies (TSEs or prion diseases) could be spread by artificial insemination, embryo transfer and other more advanced reproductive technologies which are used for genetic improvement and also for purposes such as production of recombinant drugs for medical use. Although the technologies are most used in cattle, they are increasingly used in sheep, goats and deer as well, all of which can be naturally affected by TSEs. In general, provided appropriate precautions are taken, the risks of TSE carriage specifically by the gametes (spermatozoa and oocytes) or by in-vivo-derived embryos per se appear to be negligible, but further research, some of which is already in progress, will be helpful to give assurance on this point. Greater concerns relate to the many biological products that are used in the technologies, e.g. pituitary hormones used for the superovulation of donors, and various tissues and blood products used in semen and embryo culture/transport media, some of which have the potential to carry TSE infectivity if derived from infected animals. The myriad instruments and items of technical equipment that are used also give cause for concern because if they become contaminated with TSEs they may, due to their construction, be impossible to sterilise properly.

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T9B-3YHG1FN-7&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=45995324a09e9936465ed8a3ac7c4989

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 210, 211, 820, and 1271 [Docket No. 97N-484S] Suitability Determination for Donors of Human Cellular and Tissue-Based Products AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule.

http://medical.cms.itri.org.tw/download/TEMPSreg/21CFR1271_Cproposed.pdf

---- Original Message ---- Subject: Re: Adverse events associated with dietary supplements: an observational study From: Terry S. Singeltary Sr flounder@wt.net To: mpalmer@landspitali.is, lancet.editorial@lancet.com CC: john.mcconnell@lancet.com, pamela.das@lancet.com, james.butcher@lancet.com, rebecca.love@lancet.com, journal.office@lancet.com Date: Mon, 13 Jan 2003 Re: Adverse events associated with dietary supplements: an observational study LANCET JANUARY 11, 2003 Greetings to the Lancet and Authors of this article, I hope you don't mind me writing this lengthy letter. This article and its warning was a long time coming for the supplement industry and the dangers some of its products pose to human health. Some of these supplements make claims which under no circumstances could they be true. However, what I find most disturbing is that there were no warnings of the potential for transmission to humans of TSEs from some of these nutritional supplements which contain animal organs and some containing the most high risk SRMs (specified risk materials) that could transmit TSEs to humans. Again, I think your article should have mentioned this most disturbing fact. There have been documented cases of humans taking supplements containing animal organs who subsequently died from CJD. Of course, with no testing to date to confirm the source and route of transmission, it is impossible to confirm this. Also, the incubation period makes it very difficult to trace route and source. However, with the KNOWN transmission studies to date >from TSEs, and the fact that all the world's cattle that came down with BSE were ingesting a nutritional supplement to super-ovulate cattle. (Not to forget about the potential for some BSE cases to come from vaccinations containing pituitary-derived SRMs.) TWA LITTLE minute http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf

COMMERCIAL IN CONFIDENCE http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf

NOT FOR PUBLICATION http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf

http://www.bseinquiry.gov.uk/yb/1988/11/04003001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf

NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE snip... I was quite prepared to believe in unofficial pituitary hormones, also in the 1970's, whether as described by Dr. Little, or in other circumstances, for animal use. snip... The fact that there were jars of pituitaries (or extract) around on shelves is attested by the still potent 1943 pituitaries, described in Stockell Hartree et al. (J/RF/17/291) which had come from the lab. at Mill Hill. Having taken the trouble to collect them, they were not lightly thrown out... http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf

more on the 1968 medicine act, they forgot to follow http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf

Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer) http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf

(It was noted with concern that hormone extracts could be manufactured by a veterinary surgeon for administration to animals under his care without any Medicines Act Control.)

http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf

TWA LITTLE STATEMENT 331 http://www.bseinquiry.gov.uk/files/ws/s331.pdf

IN CONFIDENCE

EMBRYO TRANSFER

http://www.bseinquiry.gov.uk/files/yb/1990/03/12001001.pdf

CONFIDENTIAL

BSE STANDING COMMITTEE - Dr C Gibbs 12/13 March 1990

http://www.bseinquiry.gov.uk/files/yb/1990/03/12003001.pdf

THE POSSIBLE VERTICAL TRANSMISSION OF BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) REPORT OF THE WORKING GROUP SUBMITTED TO THE SCIENTIFIC STEERING COMMITTEE AT ITS MEETING OF 18-19 MARCH 1999

http://ec.europa.eu/food/fs/sc/ssc/out44_en.pdf

TSS


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