Recommendations on assisted reproduction during pandemic

Posted July 21, 2020

Recently, the Brazilian National Surveillance Agency (Agência Nacional de Vigilância Sanitária, Anvisa) issued a technical note with recommendations on the resumptions of Assisted Human Reproduction (AHR) procedures during the new coronavirus pandemic.

The update was discussed with representatives of Blood, Tissues, Cells and Organs Management Agency (Gerência de Sangue, Tecidos, Células e Órgãos – GSTCO/Anvisa), Brazilian Society of Human Reproduction (Sociedade Brasileira de Reprodução Humana, SBRH), Brazilian Society of Assisted Reproduction (Sociedade Brasileira de Reprodução Assistida, SBRA), and Brazilian Association of Embryologists in Reproductive Medicine (Associação Brasileira de Embriologistas em Medicina Reprodutiva, Pronúcleo).

The text maintains the recommendation to postpone treatments, in order to protect patients and health professionals from situations that may increase the risk of infection, until the situation is remedied. Exceptions for this recommendation include oncologic cases, advanced maternal age, and low ovarian reserve (the so-called time-sensitive cases).

Dr. Paula Andrea de Albuquerque Salles Navarro, professor and researcher at INTC Hormona Universidade de São Paulo (USP), Campus Ribeirão Preto, points out that resumption should be made in a cautious and gradual manner, as recommended by the technical note.

Reopening of BCTGs

The Technical Note anticipates the possibility of reopening Germinal Cells and Tissues Banks (GCTBs), which should be made in a cautious and gradual manner. Additionally, GCTBs should establish specific protocols, based on risk management, considering numerous factors, such as: number of employees; need of using specific PPE; structural conditions of the institution (so as to bear the flow of patients and employees); logistical support, and provision of essential materials and supplies.

According to Dr. Navarro, the note makes it clear that GCTBs may open only if the local epidemiological situation permits. “The process should be conducted after the development of specific protocols for each GCTB, which minimizes the risks of transmission for patients, health professionals, gametes, and embryos, as well as ensures logistics for the continuity of treatments in times of Covid-19”, she explained.

Patient Selection

According to Anvisa’s Note, the selection of patients and donors should be thorough and early. Screening will be made using a specific mandatory questionnaire covering information on Covid-19 typical signs and symptoms, as well as its less common symptoms.

Anvisa recommends also that both symptomatic cases and individuals from the group with increased risk of severe disease, according to WHO guidelines, should be excluded from the selection process.

Consent Form

Anvisa’s recommendations establish also the need of signing a specific Informed Consent Form – ICF clearly informing the patients that, “little is known about the effects of SARS-CoV-2 infection during pregnancy and on embryos and gametes”. Dr. Navarro believes that the recommendation of a specific ICF is crucial for patients to aware of uncertainties and risks related to the new coronavirus, including the likely possibility of cancelling the treatment in case of onset of any Covid-19 symptoms and/or signs.

Donation of Gametes and Embryos

According to Anvisa, requests for approval of import of gametes (oocytes and semen) will be assessed individually, considering the epidemiological situation of the sample’s country of origin of the sample and specific clinical and laboratory screenings established for gamete donors.

If information is not available, only samples collected before 01/30/2020 will be accepted. The Agency establishes also that, exceptionally, during the pandemic period, the time of validity of the import approval letter is expanded to 60 (sixty) after the document was signed by the Blood, Tissues, Cells and Organs Management Agency – GSTCO/Anvisa.

Considerations

According to the researcher, the current content of the technical note is up-to-date and reasonable. “The note presents relatively conservative measures, justified by the numerous uncertainties regarding Covid-19. The possibility of reopening BCTGs will be assessed according to the local epidemiological situation and to health authority guidelines”, she explains.

“A commitment was made to conduct periodic updates of recommendations on Assisted Human Reproduction procedures in the context of coronavirus pandemic whenever justified by new scientific evidence.” she concludes.