Heterologous
fertilization
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.
Normative requirements
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).
Selection of the donors
The donation of gametes is allowed to male subjects aged 18 to 40 years and to female subjects aged 20 to 35 years.
Choice of donor's features
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
Ethnicity
Phenotype: weight and height, constitution, color of eyes, color and type of hair, complexion
Number of donations
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.
Donors' anonymity and privacy
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.
- Clinical male indications
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Indications are all medical or iatrogenic situations of proven infertility that determine the unavailability of usable sperm. - Male partner with demonstrated severe infertility (ie, azoospermia and severe oligoastenoteratozoospermia or failed fertilization with intracytoplasmic sperm injection [ICSI]).
- male partner with incurable ejaculatory dysfunction.
- Men who know they are affected or carriers of a significant genetic defect, or who have a family history of a condition for which carrier status can not be determined.
- Male partner with a sexually transmitted infection that can not be eliminated.
- Men with iatrogenic factor infertility.
- The female partner is Rh-negative and severely isoimmunized and the male partner is Rh-positive. - Sperm donation program
And use of donor semen -
The donor semen can be used for in vivo Medically Assisted Reproductive techniques (intrauterine insemination) or in vitro fertilization and embryo transfer, based on the assessment of woman's gynecological characteristics (age, hormonal and residual ovarian reserve structure, duration of infertility, and previous treatments).
how to import and export of gametes
The center collaborates with authorized banks in accordance with the quality standards and safety requirements of the directives 2004/23 / EC, 2006/17 / C and 2006/86 / EC.
The center guarantees the traceability of biological samples in every step, in accordance with article 8 of the legislative decree of 6 November 2007, n. 191, and Article 14 of Legislative Decree 25 January 2010, n. 16, ensuring compliance with quality and safety standards required by European and national regulations, and the specific guidelines. - Male gametes
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The center refers to accredited / licensed tissue institutes to obtain male gametes in accordance with current European legislation. The center provides, through contractual agreement with the bank of reference, that the selection of potential donors takes place through the assessment carried out by a multi-specialized team consisting of an endocrinologist / urologist with andrological skills, a biologist, a geneticist and a psychologist, under the supervision of the director of the center.
The main criteria for the choice of the donor are the good state of health and the absence of genetic abnormalities within the family, detected by careful genetic history and / or by means of a questionnaire validated by geneticist reference.
The donor must provide information about the state of helth of both biological parents, he must be capable of understanding and will, be in good physical and mental health and present no history suggesting hereditary or familiar diseases.
A psychological evaluation and counseling is performed for all sperm donors.
The center uses only semen samples with values above the 50th percentile of the reference values of WHO 2010 (international guidelines) as regards concentration and progressive motility of sperms. The recovery after thawing must provide a percentage of spermatozoa with rectilinear motility> 50% of that of the pre-cryopreservation semen.
- Clinical female indications
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Indications are all medical or iatrogenic situations of proven sterility when the woman does not have her own eggs:
Women with hypergonadotropic hypogonadism;
Women of advanced reproductive age but of still childbearing potential age;
Women with reduced ovarian reserve after homologous fertilization failure;
Women who know they have or bring a significant genetic defect, or who have a family history of a condition for which carrier status can not be determined;
Women with poor quality oocytes and / or embryos or repeated failed attempts to conceive through Medically Assisted Reproductive Techniques (ART);
Women with iatrogenic factor of infertility. - Egg donation and embryo transfer program
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Egg donation requires ovarian stimulation, ultrasound monitoring and collection of the oocytes; thus it involves, unlike the male gametes donation, substantial inconvenience and risks for the donor. Because of the difficulties that the Centre has encountered in the recruitment of donors in order to meet the demands of the infertile couples, in compliance with binding legislation, the Centre has established a procedure that allows couples to access the heterologous fertilization using oocytes obtained from other tissue banks, avoiding costly and stressful journeys.
At the request of patients embryos THe donor eggs can be cryopreserved and subsequently transferred to LIVET Center to be fertilized by male partner sperm and transferred into the uterus of the recipient. - Oocyte donors
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The egg donation involves a Free, anonymous and voluntary donation, with informed consent to the treatment and the related risks.
Candidates are the following:
Women who spontaneously and altruistically decide to donate their gametes, who are not undergoing an assisted fertilization treatment;
Women who are undergoing an assisted reproductive treatment (egg sharing);
Women who have frozen their gametes in the past and are unwilling to use them anymore, so they decide to donate.
The gametes donor candidates at points 2 and 3, can be selected only if the donors satisfy the general selection criteria.
The women who contact the Centre to donate their gametes spontaneously and altruistically, are routed to one of the data managers to evaluate the suitability for donation.
Women who start a PMA path, considered suitable for donation, during the informed consent, are informed of the possibility of donating supernumerary eggs.
Women with frozen eggs at the time of the annual renewal of the consent are informed about the possibility of donating cryopreserved oocytes.
The choice of the donor requires a careful and meticulous selection process by our team under the supervision of the Head of the Centre, by means of:
medical and gynecological examination;
psychological counseling, possibily in the presence of the partner, followed by an evaluation questionnaire;
blood tests to evaluate the overall health of the donor and electrocardiogram;
blood type and Rh factor, karyotype, genetic investigations by questionnaire validated by geneticist and / or genetic counseling to rule out the possibility that the donor is a carrier of hereditary diseases;
infective screening for hepatitis B, hepatitis C, HIV, syphilis and CMV.
Donors are exclusively women of young age (between 20 and 35 years) with proven fertility assessed by the detection of possible own pregnancies already completed and / or hormonal profile.
The main criteria in choosing a donor are the good state of health and the absence of genetic abnormalities within the family. The donor must be capable of understanding and will, in good mental and physical health and have no history of hereditary or familiar diseases.
