The heterologous fertilization is a Medically Assisted Reproductive procedure, which has recourse to a donor gametes (eggs or sperm) external to the couple, when one or both members are infertile.
In Italy heterologous fertilization is regulated by the Constitutional Court ruling 162/2014, by the document of the Conference of Regions and Autonomous Provinces 14/109/CR02/C7SAN "Document on issues related to heterologous fertilization following the Constitutional Court ruling 162/14" and the specific provisions to regulate the donation of gametes legislated by law 40/2004 and legislation relating to the donation of tissues and cells already applied to assisted reproduction centers (Legislative Decrees 191/2007 and 16/2010 implementing Directives 2006/17/EC ALL. 3 and 2006/86/EC implementing Directive 2004/23/EC as regards the technical requirements for the donation, procurement and inspection of tissue and cells, as well as for as for the requirements for traceability, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells and related application guidelines approved by the State Conference - Regioni March 15, 2012).
Gametes donation is available for married or cohabiting couples of different sex, adult, in childbearing potential age, both alive, with irreversible infertility, verified and certified using appropriate diagnostic tools.
The female partner has to be younger than 50 years (women over 50 years of age are excluded for the high incidence of obstetric complications).
The donation of gametes is allowed to male subjects aged 18 to 40 years and to female subjects aged 20 to 35 years.
It is not possible for patients to choose specific phenotypic characteristics of the donor in order to avoid unlawful eugenic selections. As heterologous fertilization is aimed to obtain a pregnancy, the gynecologist-biologist team ensures the compatibility of the main characteristics of the receiving pair to those of the donor.
This activity is carried out by evaluating the following characteristics:
Blood group and Rh factor
Phenotype: weight and height, constitution, color of eyes, color and type of hair, complexion
In gamete donation it is expected that the same donor can not determine more than ten births. This limit may only be waived in cases in which a couple who has already had a child through heterologous assisted reproduction, intends to undergo once again this procedure using the reproductive cells of the same donor.
Maintaining the anonymity rule in Article 14 of Legislative Decree 6 November 2007, n. 191, as amended, the donation must be anonymous (ie it must not be possible for the donor to go back to the recipient and vice versa). Clinical data of the donor may be disclosed by medical staff only in extraordinary cases, upon specific request and institutionalized procedures, in case of medical problems of the children, but never to the recipient couple.
The access to information is managed, ensuring the traceability control, through the management software. Any future change to the rules of anonymity of the donation after the treatment will still guarantee anonymity to donors who have donated before the new legislation. People participating in donation programs should be assured that their privacy will be respected.