South Africa’s latest medically assisted reproduction draft regulations: close, but no cigar

Medies-geassisteerde voortplanting in Suid-Afrika word tans gereguleer deur regulasies wat in 2012 gepromulgeer is ingevolge die Nasionale Gesondheidswet 61 van 2003. In Maart 2021 het die minister van Gesondheid nuwe konsepregulasies gepubliseer vir kommentaar. Hierdie artikel ontleed die nuwe konsepregulasies teen die agtergrond van groeiende regspraak in die gebied van medies-geassisteerde voortplanting, asook teen die agtergrond van nuwe tegnologiese ontwikkeling in hierdie gebied oor die afgelope dekade. In die eerste deel van die artikel word aspekte waarin die konsepregulasies verbeter het op die huidige regulasies uitgewys en ontleed, te wete (i) die nuwe, meer akkurate definisie van “gameetskenker”; (ii) die verhoogde perk op die hoeveelheid kinders wat verwek mag word met die gamete van ’n enkele skenker; (iii) die betrokkenheid van die direkteur-generaal in die vasstelling van vergoeding vir verskaffing van gamete; en (iv) die terugkeer na gemeenregtelike regulering van eienaarskap van gamete en in vitro embrio’s. Die tweede deel van die artikel word toegespits op aspekte waarin die konsepregulasies verbeter behoort te word, naamlik (i) inkonsekwentheid en onsamehangendheid van verskeie definisies; (ii) die beperking dat spermselle slegs deur self-stimulasie bekom mag word vir medies-geassisteerde voortplanting; en (iii) die gebrek aan regulering van menslike oorerflike genoom-redigering. Die derde deel van die artikel verskaf ’n oorsig van die drie bepalings van die 2012 regulasies wat tans die onderwerp is van ’n grondwetlike hofsaak en wys hoe die 2021 konsepregulasies poog om die knelpunte in die hofsaak aan te spreek. Hierdie drie bepalings is (i) die vereiste dat ’n paartjie (hetsy getroud of in ’n permanente verhouding) hulself moet onderwerp aan sielkundige evaluasie indien hulle mekaar se gamete wil gebruik vir medies-geassisteerde voortplanting; (ii) die verbod op voor-inplantingstoetsing van in vitro embrio’s vir nie-terapeutiese geslagseleksie; en (iii) die verbod op bekendmaking – deur énigiemand – van inligting oor mense wat gebruik gemaak het van medies-geassisteerde voortplanting, óf wat verwek is deur medies-geassisteerde voortplanting, óf wat gamete geskenk het vir medies-geassisteerde voortplanting. Die gevolgtrekking word gemaak dat die konsepregulasies ’n prysenswaardige poging is om op die bestaande regulasies te verbeter, maar dat dit nog in talle opsigte wesenlik tekort skiet. Ten einde hierdie tekortkominge aan te spreek, word omvattende aanbevelings gemaak oor hoe om die konsepregulasies aan te pas.

Self-Monitoring of Urinary Hormones in Combination with Telemedicine — a Timely Review and Opinion Piece in Medically Assisted Reproduction

Cycle monitoring via ultrasound and serum-based hormonal assays during medically assisted reproduction (MAR) can provide information on ovarian response and assist in optimizing treatment strategies in addition to reducing complications such as ovarian hyperstimulation syndrome (OHSS). Two surveys conducted in 2019 and 2020, including overall 24 fertility specialists from Europe, Asia and Latin America, confirmed that the majority of fertility practitioners routinely conduct hormone monitoring during MAR. However, blood tests may cause inconvenience to patients. The reported drawbacks of blood tests identified by the survey included the validity of results from different service providers, long waiting times and discomfort to patients due to travelling to clinics for tests and repeated venepunctures. Historically, urine-based assays were used by fertility specialists in clinics but were subsequently replaced by more practical and automated serum-based assays. A remote urine-based hormonal assay could be an alternative to current serum-based testing at clinics, reducing the inconvenience of blood tests and the frequency of appointments, waiting times and patient burden. Here we provide an overview of the current standard of care for cycle monitoring and review the literature to assess the correlation between urine-based hormonal assays and serum-based hormonal assays during MAR. In addition, in this review, we discuss the evidence supporting the introduction of remote urine-based hormonal monitoring as part of a novel digital health solution that includes remote ultrasound and tele-counselling to link clinics and patients at home.

Well-being of children born after medically assisted reproduction

Background The increasing number and proportion of children born after medically assisted reproduction (MAR) has raised concerns and motivated research about the impact of MAR on the well-being and development of children. Objective We summarize existing studies on the well-being and development of children conceived through MAR. Materials and methods Review of existing studies. Results Children conceived through MAR are at increased risk of adverse birth outcomes such as low birthweight and preterm delivery compared to naturally conceived children. The higher rates of multiple births amongst MAR-conceived children continue to represent an important driving factor behind these disparities. Reassuringly, elective single embryo transfer (eSET)—which is associated with more favourable pregnancy outcomes among MAR-conceived children—is becoming more common. Despite the early life health disadvantages, the evidence on later life outcomes such as physical, cognitive and psychosocial development is generally reassuring. On average, MAR-conceived children show similar or better outcomes than naturally conceived children. The selected and advantaged socioeconomic characteristics of parents who conceive through MAR are likely to play an important role in explaining why, on average, MAR-conceived children perform better than naturally conceived children—particularly in terms of cognitive outcomes. In contrast, there is some evidence pointing to potentially increased risks of mental health problems among MAR-conceived children. Conclusion There is need for continued monitoring and longer follow-up studies on the well-being of these children in order to better understand whether their outcomes are similar to or different from those of naturally conceived children, and, if so, why.

Outcomes of SARS-CoV-2 infected pregancies after medically assisted reproduction

Study question What is the impact of SARS-CoV-2 infection on the outcome of a pregnancy after medically assisted reproduction? Summary answer Our results suggest that medically assisted reproduction (MAR) pregnancies are not differentially affected by SARS-CoV-2 infection compared to spontaneous pregnancies. What is known already Information on the effects of COVID-19 on pregnancy after MAR is scarce when women get infected during MAR or early pregnancy, even though such information is vital for informing women seeking pregnancy. Study design, size, duration Data from SARS-CoV-2 affected MAR pregnancies were collected between May 2020 and June 2021 through a voluntary data collection, organised by the European Society of Human Reproduction and Embryology (ESHRE). Participants/materials, setting, methods All ESHRE members were invited to participate to an online data collection for SARS-CoV-2-infected MAR pregnancies. Main results and the role of chance The dataset includes 80 cases from 32 countries, including 67 live births, 10 miscarriages, 2 stillbirths and 1 maternal death. An additional 25pregnancies were ongoing at the time of writing. Limitations, reasons for caution An international data registry based on voluntary contribution can be subject to selective reporting with possible risks of over- or under-estimation. Wider implications of the findings The current data can be used to guide clinical decisions in the care of women pregnant after MAR, in the context of the COVID-19 pandemic. Study funding/competing interest(s) The authors acknowledge the support of ESHRE for the data registry and meetings. JT reports grants or contracts from Sigrid Juselius Foundation, EU and Helsinki University Hospital Funds, outside the scope of the current work. The other authors declare that they have no conflict of interest.

P–509 Patients’ Uses and Experiences of Medically-Assisted Reproduction in France in 2020

Study question What are the uses and real-life experiences of patients currently treated in France in medically-assisted reproduction (MAR) centers? Summary answer One in four patients is in a situation of significant pain in relation to MAR; half are not optimistic about the outcome of their treatment. What is known already Internationally, work on the quality of life and impact of treatments has been completed in the field of endometriosis (Culley et al. 2017). In the field of MAR in France, one study underlines an important level of general well-being, with nearly 4 people out of 5 who say they are rather content (Coudrière et al. 2020). A better understanding of this result is however still lacking, especially in respect to whether patients actually believe in the success of their treatments, or how dependent satisfaction is on variables, like age, secondary infertility or the number of years engaged in fertility treatments. Study design, size, duration We conducted an online self-administered questionnaire by means of a two-step process: a first survey dedicated to patients’ uses was carried out from January 15, 2020 to February 26, 2000; the following and complementary survey about real-life experience was conducted from March 3, 2020 to April 10, 2020. The initial sample included 1503 people before selecting relevant participants. Participants/materials, setting, methods The final sample of 967 patients targets patients that were enrolled in a French procreative medical center at the time of the study. Were excluded from the sample: ex-patients, patients who have not started treatment or are not followed in France, solo and homosexual care patient trajectories. The questionnaire was composed of 178 questions. In the questionnaire dealing with MAR uses, six fields were examined; in the case of real-life experience, eight themes were questioned. Main results and the role of chance The study shows that one in four patients suffers significantly in relation to MAR care; nearly half are pessimistic about treatment outcome and 65% claim that MAR prevents full enjoyment of everyday life. Further findings include: MAR is globally satisfying regarding the quality of care provided by practitioners and staff (80%), general administration of patients (77 to 87%), first encounters with staff and center (78 to 91%), quality of dialogue (81%), physical state of the premises (82 to 97%), continuum with professional activity (73%). Where centers/practitioners need to pay attention: one out of two patients wanted more means of communication; time management was an issue; 41% state that infertility prevents entrepreneurial outreach and general success; treatments strongly disrupt work for 83% and reduce performances for 79%; work rights, while known, were not respected in ¼ cases. Discoveries made: young women are not very positive, men are not well-identified in such medical trajectories, women’s body image is completely transformed for 95%, 85.5% of women are depressed by seeing a pregnant woman, and 15% do not think about wanting a child daily. Limitations, reasons for caution This research, carried out online, was distributed mainly through a grassroot organization, potentially biasing representativeness. Also, the study finished at the start of the first French confinement. Previous studies show that the general context does not impact results, but this limitation cannot be ignored (Fisher, Bayhem, 2019). Wider implications of the findings: These findings underline the need for a comprehensive conception of MAR, including more than medical support. It highlights anew the need to better take men into account in future research as well as people in their twenties as knowledge of these categories of people is still lacking. Trial registration number Not applicable