Many assisted reproduction treatments require sperm donation, both in In Vitro Fertilization cycles for couples and in treatments for women who decide to become single mothers. In all these cases, the quality and safety of the donated samples are of utmost importance. This process is carried out within a strict regulatory framework and under advanced medical controls that guarantee maximum reliability for patients.
“The goal is for every sample used in a reproductive treatment to meet absolute safety standards, from the donor’s initial evaluation to the final release of the sample,” explains Dr. Paloma Baviera, a gynecologist and assisted reproduction specialist at IVF-Life Alicante.
Spanish legislation establishes a very precise system governing gamete donation. In Spain, donation is anonymous by law and is subject to strict supervision under protocols that regulate who can donate, which tests must be performed, and how samples must be documented.
One of the key points established by regulations is that a single donor may not result in more than six live births throughout the national territory. This limitation aims to prevent genetic coincidences within the population and to ensure controlled use of each donor.
“The Spanish legal framework is very clear and, at the same time, highly protective. It allows us to work with confidence and offer patients the level of safety that is essential in this type of treatment,” notes Dr. Baviera. In this regard, she highlights the importance of a key monitoring tool in Spain: the Assisted Human Reproduction Information System (SHIRA), a national registry that records all donations and all treatments using donated gametes.
Thanks to this system, it is possible to accurately track the number of live births derived from each donor and to apply biovigilance measures, as each donor is assigned a unique code within the system. If any suspicion of a genetic or health-related issue arises, the associated samples and embryos are immediately blocked.
“SHIRA is an essential safety net and a guarantee for both patients and the system as a whole, allowing us to act swiftly if any anomaly is detected that could affect the quality of these gametes,” explains Dr. Paloma Baviera.

Sperm donors undergo a rigorous selection process focused on ruling out risks and ensuring that samples are fully suitable for clinical use. The evaluation includes a general health assessment and a complete screening for sexually transmitted infections (STIs), as well as additional tests to assess semen quality and analyze the karyotype. Family history of hereditary diseases, psychiatric conditions, cancer, and endocrine disorders, among others, is also carefully reviewed.
This assessment is further complemented by genetic compatibility testing between the donor and the patient, a key measure to minimize the risk of recessive hereditary diseases. “Genetic testing is not intended to select the future baby’s physical traits, but rather to ensure that there is no risk of transmitting recessive conditions. It is a preventive tool, not an aesthetic choice,” clarifies Dr. Baviera.
The regulatory update introduced in 2024, focused on the Inspection Guidelines for Assisted Human Reproduction (AHR) centers and Order SND/606/2024, added an additional safeguard: no European donor may be used in Spain unless they fully comply with the requirements established by national legislation and are authorized by health authorities. This means that imported samples must undergo the same procedures as those from local donors.
“The commitment of Spanish clinics is that all samples we use, regardless of their origin, must meet exactly the same standards. We do not make, and cannot make, any exceptions,” emphasizes Dr. Baviera. She adds, “We know that trust is essential, which is why we work within a system where nothing is left to chance. Every step is designed to provide clinical safety and peace of mind to those who decide to begin a reproductive treatment.”
One of the aspects that generates the most interest among patients is donor selection. In Spain, donation is completely anonymous, but regulations also require clinics to choose a donor whose physical characteristics—such as eye color, hair color, build, and height—are as similar as possible to those of the recipient. This criterion does not serve a genetic purpose, but rather a social and emotional one.
The aim is to help ensure that the future baby shares physical traits with the woman who will carry and raise them, allowing the family experience to develop as naturally as possible. In addition to physical matching, genetic compatibility between the patient and the donor is also assessed. Before assigning a sample, both carrier screening panels are compared to rule out shared mutations that could lead to recessive hereditary diseases. This is a fundamental preventive measure, as it adds an extra layer of clinical safety.