Assisted fertilization

Heterologous fertilization in Italy: law, indications, costs and age limits

Heterologous fertilization is a Medically Assisted Procreation Technique (MAP) in which at least one of the two gametes (egg or sperm) is external to the couple, being the result of a donation from a third person.

In this process, therefore, the subjects involved are the receiving couple and a donor or a donor.

How is PMA treatment performed with gamete donation

Heterologous PMA can be level I or II.

In the case of level I, he performs an IUI (intrauterine insemination) with donation of sperm. It is the simplest and least invasive route.

In case of need to resort to the II level, heterologous fertilization can be:

  • In vitro fertilization with sperm donation
  • In vitro fertilization with egg donation
  • In vitro fertilization with egg and semen donation

In the case of oocyte donation , the donor undergoes a cycle of stimulation for multiple follicle maturation, then ovulation induction and oocyte retrieval under anesthesia.

The oocytes obtained can be vitrified and then cryopreserved for future use, or if the recipient couple is ready, they are fertilized with the partner’s seminal fluid and frozen blastocysts .

For synchronization problems between donor and recipient, it is preferable to cryopreserve the blastocysts and transfer them one at a time to the recipient woman.

The recipient woman undergoes endometrial preparation therapy (first estrogen and then progesterone), in order to face the transfer of the blastocyst at the correct moment of maturation of the endometrium itself.

Who can resort to heterologous fertilization in Italy?

Law 40 of 2004 prevented heterologous ART in Italy. In 2014 the Constitutional Court declared illegitimate the art. 4, paragraph 3 of the law n. 40/2004 which established the ban on resorting to heterologous medically assisted procreation techniques.

From that moment on, an attempt was made to establish rules which were put on paper by the document of the Conference of Regions and Autonomous Provinces 14/109/CR02/C7SAN .

On the basis of this document, the couple in which an irreversible condition of infertility or sterility has been ascertained and certified and who is:

  • married or cohabiting
  • of different sex
  • in which both are alive
  • adult
  • of potentially childbearing age for both (however heterologous is not recommended in women aged > 50 even if still potentially fertile, due to the high incidence of obstetric complications)

Male and female indications for the use of heterologous PMA

In order to be able to resort to PMA in Italy, a couple must be in possession of a medical certificate which specifies the reasons why this technique is necessary.

Motivations can be masculine and/or feminine.

Female indications to heterologous PMA

The woman may not have her own oocytes for:

  • hypogonadotropic hypogonadism
  • advanced reproductive age but still of childbearing potential
  • reduced ovarian reserve after homologous fertilization failure
  • carrier or affected by hereditary genetic disease
  • with poor quality oocytes and/or embryos or repeated homologous PMA failures
  • with iatrogenic infertility factor (e.g. following surgery or chemotherapy)

Male indications for heterologous PMA

The male partner may not have usable sperm for:

  • severe male factor (azoospermia) or failure to fertilize by ICSI after sperm recovery with testicular biopsy.
  • incurable ejaculatory dysfunction
  • hereditary genetic pathology
  • sexually transmitted infection that cannot be cured
  • iatrogenic infertility factor (e.g. for chemotherapy or interventions)
  • Rh-negative and severely isoimmunized female partner and Rh-positive male partner

The centers that perform heterologous PMA in Italy

Most of the centers (public, private or affiliated) which in 2017 carried out level II and III activities with donated gametes are located in Veneto, Emilia Romagna, Tuscany, Lazio, Campania and Sicily (70 centres, equal to 76.9% ). The 10 public centers that carried out activities were present in Tuscany (3 centres), in Emilia Romagna (2 centres), in Friuli Venezia Giulia (2 centres), in the province of Bolzano (1 centre), in Lazio (1 centre) and in Sicily (1 centre).

The 2,702 cycles with frozen embryos from a foreign bank are presumably largely the result of fertilizations that took place abroad with the following procedure:

  • seed exported from Italy,
  • egg donation
  • their fertilization in the foreign center using the exported Italian semen,
  • subsequent importation into Italy of embryos trained (and cryopreserved) abroad.

The costs of PMA in Italy

The homologous and heterologous PMA have been included in the new LEAs since 2017 therefore theoretically also in Italy it is possible to resort to the heterologous PMA under the NHS and therefore at the cost of the ticket only. 

In the document Permanent Conference for Relations between the State, the Regions and the Autonomous Provinces of Trento and Bolzano 14/121/CR7c/C7 of 25 September 2014, conventional tariffs have been defined which are as follows :

  • 1500 euros for heterologous through an IUI (including 500 euros for drugs)
  • 3500 for heterologous fertilization with donor sperm (including 500 euros of medicines)
  • 4,000 euros for heterologous fertilization with donor oocytes (including 500 euros for drugs)

In private centres, the cost for a cycle of second or third level MAP is around 4000-5000 euros to which another 1000-2000 euros are added in the case of gamete donation.

So essentially in Italy the cost of a heterologous PMA fluctuates between 5,000 and 8,000 euros.

Many couples resort to the heterologist in Spain where the costs can even reach 12,000 euros in the best centres. The price can go down if you choose a donor to share with another couple.

The success rates of a heterologous PMA

What is the percentage of natural pregnancy in a young and fertile couple per menstrual cycle? At most 30%.

This is also the success rate of heterologous PMA. For this it is normal that several cycles of attempts may be necessary.

PMA centers (especially foreign ones) that advertise higher percentages are misleading . Percentages of 70-80% are obtained yes, but with more cycles of attempts. And this must be clarified with the doctors of the clinic when it is decided to proceed with them.

Dr Kathryn Barlow

Kathryn Barlow is an OB/GYN doctor, which is the medical specialty that deals with the care of women's reproductive health, including pregnancy and childbirth.

Obstetricians provide care to women during pregnancy, labor, and delivery, while gynecologists focus on the health of the female reproductive system, including the ovaries, uterus, vagina, and breasts. OB/GYN doctors are trained to provide medical and surgical care for a wide range of conditions related to women's reproductive health.

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