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

2022 ◽  
Vol 2022 (1) ◽  
pp. 1-24
Author(s):  
Donrich Thaldar ◽  
Bonginkosi Shozi

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.

2014 ◽  
Vol 2014 ◽  
pp. 1-14 ◽  
Author(s):  
Francesco Paolo Busardò ◽  
Matteo Gulino ◽  
Simona Napoletano ◽  
Simona Zaami ◽  
Paola Frati

Medically Assisted Reproduction (MAR), involving in vitro fertilisation (IVF), and research on embryos have created expectation to many people affected by infertility; at the same time it has generated a surplus of laws and ethical and social debates. Undoubtedly, MAR represents a rather new medical field and constant developments in medicine and new opportunities continue to defy the attempt to respond to those questions. In this paper, the authors reviewed the current legislation in the 28 EU member states trying to evaluate the different legislation paths adopted over the last 15 years and highlighting those EU countries with no specific legislation in place and MAR is covered by a general health Law and those countries in which there are no laws in this field but only “guidelines.” The second aim of this work has been to compare MAR legislation and embryo research in EU countries, which derive from different origins ranging from an extremely prohibitive approach versus a liberal one, going through a cautious regulatory approach.


2009 ◽  
Vol 58 (4) ◽  
Author(s):  
Carlo Casini

Il contributo propone all’attenzione il II Rapporto sull’applicazione della legge italiana in materia di “procreazione medicalmente assistita” (PMA) (Legge 40/2004), elaborato nell’aprile 2009 all’indomani della quarta relazione ministeriale del 25 marzo 2009 sullo stesso tema. La particolarità del presente Rapporto consiste nell’indagare su uno dei due obiettivi della legge 40/2004: tutelare il diritto alla vita del concepito. Infatti, mentre è alta la concentrazione sull’obiettivo di “superare la sterilità e la infertilità”, lo scopo di difendere il diritto alla vita del concepito considerato dalla stessa legge “soggetto” al pari degli altri soggetti coinvolti nelle procedure di PMA, è troppo spesso dimenticato. Il Rapporto vuole proprio rimediare a tale dimenticanza e si chiede: di quanti nuovi esseri umani è stata evitata la distruzione per effetto della legge? Poiché, come si legge nel contributo, è chiaro che le tecniche di PMA per il fatto stesso di procreare “in vitro” espongono alla morte gli embrioni anche quando vengono trasferiti nelle vie genitali della donna (ed è questa, infatti, una delle principali riserve etiche nei confronti delle tecniche di PMA), l’indagine si occupa solo di vedere come è stato tutelato il diritto alla vita degli embrioni non trasferiti, cioè non destinati alla nascita, dalla Legge 40/2004. Emerge che l’effetto più benefico della legge è quello di aver evitato nel solo triennio 2005-2006-2007 la possibile formazione soprannumeraria di embrioni e la conseguente possibile distruzione, diretta o dovuta alla crioconservazione, di oltre 120.000 embrioni. La seconda parte della ricerca è condotta confrontando anche i dati di altri Paesi europei e dimostra che il rispetto dei limiti posti a tutela del diritto alla vita hanno anche garantito meglio la salute della donna e non hanno diminuito la percentuale del “successo”. Come è noto la recente sentenza n. 151/2009 della Corte Costituzionale ha gravemente compromesso la legge proprio nel punto di maggiore sensibilità nei confronti della tutela concreta del diritto alla vita del concepito. L’auspicio è che i dati raccolti in questo II rapporto vengano comunque presi in seria considerazione. ---------- The contribution proposes the II Report of April 2009 on the application of the Italian Law on “medically assisted reproduction” (PMA) (Law 40/2004). The peculiarity of the present Report consists of investigating one of the two purposes of the Law 40/2004: to protect the right to life of newborns. In fact, if, on one hand, attention to the purpose of “overcoming sterility and infertility” the Law considers, on the other hand the purpose of defending the right to life of newborn, that is considered as “subject” just like the others subjects involved in PMA procedures from the same law, is too often forgotten. The Report intends to remedy for this forgetfulness and it asks: how many new human beings have been saved thanks to the Law? It makes clear that the most beneficent effect of the Law is that, in the period 2005-2007, it has avoided the possible production of excess embryos and the consequent possible suppression – direct or due to the cryoconservation – of over 120.000 embryos. The second part of the search is conducted also comparing data of other European Countries and it shows that the respect of the imposed limits for protecting the right to life has also guaranteed the woman’s health and it has not reduced the outcome percentage.


Author(s):  
Laura Gambera ◽  
Anita Stendardi ◽  
Camilla Ghelardi ◽  
Benedetta Fineschi ◽  
Rosamaria Aini

Objective: The aim of this non controlled trial was to assess whether a therapy with an antioxidant supplement may improve spermatozoa quality in terms of number, motility, morphology and a higher number of successful conceptions in patients with oligoasthenoteratozoospermia undergoing cycles of medically assisted reproduction by intracytoplasmic sperm injection (ICSI). Materials and methods: 32 patients registered at A.G.I. Medica (Siena) medically assisted reproduction centre affected by fertility problems associated with oligoasthenoteratozoospermia were included in the study. Semen analysis were evaluated according to World Health Organization 2010, before and after treatment. Moreover, we used colorimetric tests to assess oxidative stress. After evaluating oocyte fertilisation rate and the quality of embryos obtained, data were statistically analysed. Result: Microscopy examination after the therapy, showed a general improvement in sperm parameters (number of sperms, progressive motility, viability and normal morphology) in both baseline and capacitated; also the levels of oxidative stress was notably lower after the treatment. Morever we evaluated the outcome of the IVF treatment, the percentage of fertilization and the number of embryos obtained, all the parameters was significantly higher in the N1 group. Conclusions: The outcomes of this trial seem to suggest that the administration of our food supplement improve semen parameters and that the evaluation of oxidative stress levels may become a diagnostic tool to assess male infertility in patients undergoing ART cycle.


Author(s):  
Thomas Strowitzki ◽  
Thomas Bruckner ◽  
Sabine Roesner

Abstract BACKGROUND IVM was implemented in medically assisted reproduction 25 years ago. IVM does not involve controlled ovarian stimulation (COS) and is mainly indicated in patients with a high risk of ovarian hyperstimulation syndrome, in particular in patients with polycystic ovary syndrome (PCOS); it is also an acknowledged option in fertility protection. However, the in-vitro culture of immature oocytes raises concerns over their developmental potential and the putative impact on children’s health. Although an increasing number of studies on obstetric and neonatal outcomes of IVM children and their development have been published in recent years, study designs are difficult to compare, since IVM is used in women with various indications and IVM protocols do not follow the same standards. OBJECTIVE AND RATIONALE The aim of this systematic review was to evaluate the current evidence from IVM children of an impact of in-vitro culture of immature oocytes. Primary outcome parameters were birthweight and children’s development up to the age of 2 years. We also compared pregnancy pathologies and the outcome of IVM children and COS children in relation to maternal indications, in particular PCOS, and to the type of IVM protocols with or without ovulation trigger as the secondary outcome parameters. IVM is an accepted clinical option for many centres; however, a comprehensive analysis of the available data is needed to establish whether the use of human oocytes that are fully matured in vitro is safe for both children and their mothers. SEARCH METHODS Google Scholar and PubMed were used for identifying peer-reviewed original articles and reviews through January 2020. A total of 191 studies were screened and 16 studies were included in the qualitative synthesis. Studies were stratified according to indications, the use of an ovulation trigger and multiplicity. OUTCOMES Birthweights of IVM singletons and multiples were comparable to their respective COS controls: birthweights were also similar if the analysis was restricted to mothers with PCOS. IVM children had a comparable birthweight to COS children, irrespective of whether an ovulation trigger was used in IVM cycles or not. The frequency of gestational diabetes (GD) in singleton pregnancies was comparable between IVM and COS, regardless of infertility background. There was also no difference in GD frequency between IVM and COS, if an hCG ovulation trigger in IVM cycles was used or not. Hypertensive disorders in singleton pregnancies of women with PCOS were significantly more frequent after IVM compared to COS, in particular if IVM cycles were performed only with in-vitro matured oocytes. There was no difference in the preterm birth rate of singleton pregnancies between IVM and COS. Preterm birth rates were still similar if only women diagnosed with PCOS were compared and whether an ovulation trigger in IVM was used or not. The malformation rate in IVM children did not differ in COS children versus children after natural conception. At the age of 2 years, IVM singletons showed similar anthropometric and mental development compared to COS children or children from natural conception. WIDER IMPLICATIONS The higher incidence of hypertensive disorders in IVM pregnancies needs monitoring during pregnancy. Current data on the development of IVM children are encouraging, although the quality of many studies is limited and long-term data beyond 2 years are scarce. Further studies should be based on generally accepted IVM protocols. Studies on long-term outcomes beyond 2 years are needed to search for potential long-time sequelae of IVM.


2015 ◽  
Vol 30 (11) ◽  
pp. 2476-2485 ◽  
Author(s):  
S. Gameiro ◽  
J. Boivin ◽  
E. Dancet ◽  
C. de Klerk ◽  
M. Emery ◽  
...  

2004 ◽  
Vol 16 (2) ◽  
pp. 226 ◽  
Author(s):  
F. Martinez-Pastor ◽  
F. Olivier ◽  
T. Spies ◽  
L. Anel ◽  
P. Bartels

Biological Resource Banks represent a potentially valuable tool for species conservation. It is, however, necessary to understand the species-specific cryopreservation process and its consequences for spermatozoa to aid in the development of assisted reproduction as a future conservation tool. The aim of this study was to assess the in vitro functionality of white rhinoceros Cerathoterium simum epididymal spermatozoa both before and after cryopreservation. Testes from a harvested white rhino bull were removed and transported at 5°C to the laboratory within 4h. The cauda epididymis was dissected out and flushed with 2mL of Tris-citrate egg yolk extender (fraction A, Biladyl, Minitüb, Germany). A 0.1mL aliquot was removed for analysis and the balance (9mL; 2mL fraction A+7mL sperm sample) mixed with an additional 27.2mL of Tris-citrate egg yolk with glycerol (fraction B, Bidadyl). The extended sample was allowed to cool to 4°C over a 6-h period before an additional 29.2mL of cooled fraction B were added (final sperm concentration=150×106mL−1). Sperm samples were loaded into 0.25-mL straws and frozen over LN2 vapor (4cm for 20min) for later assessment. Sperm straws were thawed by placing the straws in water at 37°C for 30s. Pre-freeze and post-thaw evaluations were carried out in the same manner. Media used included: HEPES for washing (20mM HEPES, 355mM sucrose, 10mM glucose, 2.5mM KOH) and HEPES saline (197mM NaCl, instead of sucrose). An aliquot was diluted with HEPES (washing) and centrifuged for 5min at 600×g; the pellet was resuspended in HEPES saline. Sperm motility (total motility %, TM;; and progressive motility %, PM) was assessed using phase contrast microscopy (×200; 37°C). Sperm plasma membrane status was assessed using the fluorescent dye, propidium iodide (50ngmL−1 in HEPES saline;; 10min, RT). Percentage of cells with plasma membranes intact (unstained;; PMI) was recorded. Mitochondrial status was assessed with the fluorescent dye, JC-1 (7.5μM in HEPES saline;; 30min, 37°C). The % of cells with an orange-stained midpiece was recorded (active mitochondria;; MIT). Resilience to hypoosmotic shock (HOS test) was assessed by diluting a sample in 100mOsm/kg HEPES saline (1:20; 15min, RT). An aliquot was stained with PI to assess plasma membrane status (HOSPMI), and the rest was fixed with formaldehyde, and % coiled tails (positive endosmosis;; HOST) was estimated using phase contrast microscopy (×400). Evaluations of PMI, MIT and HOSPMI were performed using fluorescence microscopy (×400, 450–490nm excitation filter). The results indicated that quality was good pre-freezing (TM: 60%; PMI: 86%; MIT: 100%), except for a PM value of 15%. After thawing, although there was a drop in TM (30%), there was no decrease in PM (20%). Our in vitro functional assessment indicated a loss of quality between the pre-freeze and post-thaw evaluations, but PMI and MIT maintained their pre-thaw levels (60% and 72%, respectively). The HOS test, which indicates plasma membrane integrity, decreased from the pre-freeze level (91%) to a post-thaw value of 70%. HOSTPMI was 72% pre-freeze, and decreased to 54% post-thaw. In conclusion, epididymal spermatozoa from the white rhino may retain its functionality after cryopreservation in a commerically available cryo-extender (Bidadyl). The use of assisted reproduction techniques could someday play a role in the management and conservation of the white rhinoceros and related species.


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