A systematic review of assisted and third-party reproduction guidelines regarding management and care of donors.

BACKGROUND: Gamete and embryo donors face complex challenges affecting their health and quality of life. Healthcare providers need access to well-structured, evidence-based, and needs-based guidance to care for gamete and embryo donors. Therefore, this systematic review aimed to synthesize current assisted and third-party reproduction guidelines regarding management and care of donors. METHODS: The databases of ISI, PubMed, Scopus, and websites of organizations related to the assisted reproduction were searched using the keywords of "third party reproduction", "gamete donation", "embryo donation", "guidelines", "committee opinion", and "best practice", without time limit up to July 2023. All the clinical or ethical guidelines and best practice statements regarding management and care for gamete and embryo donors written in the English language were included in the study. Quality assessment was carried using AGREE II tool. Included documents were reviewed and extracted data were narratively synthesized. RESULTS: In this systematic review 14 related documents were reviewed of which eight were guidelines, three were practice codes and three were committee opinions. Five documents were developed in the United States, three in Canada, two in the United Kingdom, one in Australia, and one in Australia and New Zealand. Also, two guidelines developed by the European Society of Human Reproduction and Embryology were found. Management and care provided for donors were classified into four categories including screening, counseling, information provision, and ethical considerations. CONCLUSION: While the current guidelines include some recommendations regarding the management and care of gamete/embryo donors in screening, counseling, information provision, and ethical considerations, nevertheless some shortcomings need to be addressed including donors' psychosocial needs, long-term effects of donation, donors' follow-up cares, and legal and human rights aspects of donation. Therefore, it is needed to conduct robust and well-designed research studies to fill the knowledge gap about gamete and embryo donors' needs, to inform current practices by developing evidence-based guidelines.

Gamete and embryo donors face complex challenges affecting their health and quality of life. To manage these challenges, healthcare providers need guidelines that are based on evidence and donors' real needs. In order to develop a comprehensive guideline that meets the needs of donors; it is important to review the current guidelines. So, in this study we reviewed the current assisted and third-party reproduction guidelines regarding management and care of donors. We searched databases and relevant websites and found 14 related documents. The main topics recommended for management and care of donors in these guidelines included screening, counseling, information provision, and ethical considerations. We recognized that some of donors' needs are neglected in these documents including donors' psychosocial needs, long-term effects of donation on donors, their follow-up cares, and legal and human rights aspects of donation. Therefore, there is need for further research to develop guidelines based on donors' unmet needs.

The evolving landscape of donor egg treatment: success, women's choice, and anonymity.

PURPOSE: To analyze donor oocyte (DE) data across 6 years for oocyte usage efficiency, trends, and whether changes impacted outcomes. METHODS: From 2014 to 2019, 323 DE embryo transfers were completed in 200 recipients using oocytes derived of 163 donors. We assessed data for oocytes being freshly retrieved (FRESH-EGG) vs. purchased frozen (FROZEN-EGG); embryos transferred fresh (FRESH-ET) vs. frozen (FROZEN-ET); cycles SHARED (two recipients) vs. SOLE (one recipient); single (SET) vs. double (DET) embryo transfers and usage of PGT-A. Primary outcome was ongoing pregnancy plus live birth (OP/LB) rate. RESULTS: A total of 229 FRESH-EGG (70%) and 94 FROZEN-EGG (30%) cycles were completed. Overall, the use of FRESH-EGG yielded a higher OP/LB compared to FROZEN-EGG (49% vs. 30%, p = 0.001); within the FRESH-EGG group, OP/LB was similar when comparing FRESH-ET vs. FROZEN-ET (58% vs. 45%, p = 0.07). Within the FRESH-ET group, those using FRESH-EGG had a higher OP/LB than those using FROZEN-EGG (58% vs. 27%, p < 0.001). SHARED vs. SOLE cycles (p = 0.6), donor age (21-32 years; p = 0.4), and age of intended parents (maternal p = 0.3, paternal p = 0.2) did not significantly impact OP/LB. Notably, the use of PGT-A did not improve odds for an OP/LB (p = 0.7). CONCLUSION: The use of FRESH-EGG with FRESH-ET without PGT-A remains superior to newer DE treatment combinations. Specifically, the use of FROZEN-EGG and PGT-A did not improve outcomes. Although changing DE practices may enhance experience and affordability, patients and providers must appreciate that choices do not always favorably impact success. Additionally, newly available genetic-ancestry testing may pose longer-term ramifications mandating change in treatment and/or counseling.

Day 5 vitrified blastocyst transfer versus day 6 vitrified blastocyst transfer in oocyte donation program.

The superiority of day 5 blastocysts compared to day 6 blastocysts in fresh cycle transfers was previously demonstrated and attributed mainly to endometrial asynchrony. Data from frozen blastocysts transfers showed conflicting results, possibly due to heterogeneous patient population and embryo quality. The aim of this study was to compare clinical pregnancy rate (CPR) and live birth rate (LBR) between transfers of vitrified day 5 blastocysts and day 6 blastocysts in oocyte donation, blastocyst-only cycles. In a retrospective, multi-center study, with a single oocyte donation program, a total of 1840 frozen embryo transfers (FET's) were analyzed, including 1180 day 5 blastocysts and 660 day 6 blastocysts transfers. Day 5 blastocyst transfers had better embryonic development and significantly higher CPRs (34.24% vs. 20.15%, P < 0.0001), higher LBRs (26.89% vs. 14.77%, P < 0.0001), less cycles to LBR (1.83 ± 0.08 vs. 2.39 ± 0.18, P = 0.003) and shorter time to LBRs (76.32 ± 8.7 vs. 123.24 ± 19.1 days, P = 0.01), compared to day 6 transfers, respectively. A multivariate stepwise logistic regression indicated, that day 5 transfer was an independent factor for CPRs (OR 1.91; 95% CI 1.43-2.54, P < 0.001) and LBRs (OR 2.26; 95% CI 1.19-4.28, P = 0.01), regardless of embryo quality, compared to day 6. In conclusion, day 5 blastocysts in oocyte donation program have significantly higher CPRs and LBRs, and present shorter time to delivery, compared to day 6 blastocysts, regardless of embryo quality.

Guidance regarding gamete and embryo donation.

This document provides the latest recommendations for the evaluation of potential sperm, oocyte, and embryo donors as well as their recipients, incorporating recent information about optimal screening and testing for sexually transmitted infections, genetic diseases, and psychological assessments. This revised document incorporates recent information from the US Centers for Disease Control and Prevention, US Food and Drug Administration, and American Association of Tissue Banks, which all programs offering gamete and embryo donation services must be thoroughly familiar with, and replaces the document titled "Recommendations for gamete and embryo donation: a committee opinion," last published in 2013.

cfDNA deconvolution via NIPT of a pregnant woman after bone marrow transplant and donor egg IVF.

Cell-free DNA is known to be a mixture of DNA fragments originating from various tissue types and organs of the human body and can be utilized for several clinical applications and potentially more to be created. Non-invasive prenatal testing (NIPT), by high throughput sequencing of cell-free DNA (cfDNA), has been successfully applied in the clinical screening of fetal chromosomal aneuploidies, with more extended coverage under active research.In this study, via a quite unique and rare NIPT sample, who has undergone both bone marrow transplant and donor egg IVF, we investigated the sources of oddness observed in the NIPT result using a combination of molecular genetics and genomic methods and eventually had the case fully resolved. Along the process, we devised a clinically viable process to dissect the sample mixture.Eventually, we used the proposed scheme to evaluate the relatedness of individuals and the demultiplexed sample components following modified population genetics concepts, exemplifying a noninvasive prenatal paternity test prototype. For NIPT specific applicational concern, more thorough and detailed clinical information should therefore be collected prior to cfDNA-based screening procedure like NIPT and systematically reviewed when an abnormal report is obtained to improve genetic counseling and overall patient care.

High-security closed devices are efficient and safe to protect human oocytes from potential risk of viral contamination during vitrification and storage especially in the COVID-19 pandemic.

PURPOSE: The main purpose and research question of the study are to compare the efficacy of high-security closed versus open devices for human oocytes' vitrification. METHODS: A prospective randomized study was conducted. A total of 737 patients attending the Infertility and IVF Unit at S.Orsola University Hospital (Italy) between October 2015 and April 2020 were randomly assigned to two groups. A total of 368 patients were assigned to group 1 (High-Security Vitrification™ - HSV) and 369 to group 2 (Cryotop® open system). Oocyte survival, fertilization, cleavage, pregnancy, implantation, and miscarriage rate were compared between the two groups. RESULTS: No statistically significant differences were observed on survival rate (70.3% vs. 73.3%), fertilization rate (70.8% vs. 74.9%), cleavage rate (90.6% vs. 90.3%), pregnancy/transfer ratio (32.0% vs. 31.8%), implantation rate (19.7% vs. 19.9%), nor miscarriage rates (22.1% vs. 21.5%) between the two groups. Women's mean age in group 1 (36.18 ± 3.92) and group 2 (35.88 ± 3.88) was not significantly different (P = .297). A total of 4029 oocytes were vitrified (1980 and 2049 in groups 1 and 2 respectively). A total of 2564 were warmed (1469 and 1095 in groups 1 and 2 respectively). A total of 1386 morphologically eligible oocytes were inseminated by intracytoplasmic sperm injection (792 and 594 respectively, P = .304). CONCLUSIONS: The present study shows that the replacement of the open vitrification system by a closed one has no impact on in vitro and in vivo survival, development, pregnancy and implantation rate. Furthermore, to ensure safety, especially during the current COVID-19 pandemic, the use of the closed device eliminates the potential samples' contamination during vitrification and storage.

Dual consent? Donors' and recipients' views about involvement in decision-making on the use of embryos created by gamete donation in research.

BACKGROUND: Reasonable disagreement about the role awarded to gamete donors in decision-making on the use of embryos created by gamete donation (EGDs) for research purposes emphasises the importance of considering the implementation of participatory, adaptive, and trustworthy policies and guidelines for consent procedures. However, the perspectives of gamete donors and recipients about decision-making regarding research with EGDs are still under-researched, which precludes the development of policies and guidelines informed by evidence. This study seeks to explore the views of donors and recipients about who should take part in consent processes for the use of EGDs in research. METHODS: From July 2017 to June 2018, 72 gamete donors and 175 recipients completed a self-report structured questionnaire at the Portuguese Public Bank of Gametes (response rate: 76%). Agreement with dual consent was defined as the belief that the use of EGDs in research should be consented by both donors and recipients. RESULTS: The majority of participants (74.6% of donors and 65.7% of recipients) were willing to donate embryos for research. Almost half of the donors (48.6%) and half of the recipients (46.9%) considered that a dual consent procedure is desirable. This view was more frequent among employed recipients (49.7%) than among non-employed (21.4%). Donors were less likely to believe that only recipients should be involved in giving consent for the use of EGDs in research (25.0% vs. 41.7% among recipients) and were more frequently favourable to the idea of exclusive donors' consent (26.4% vs. 11.4% among recipients). CONCLUSIONS: Divergent views on dual consent among donors and recipients indicate the need to develop evidence-based and ethically sustainable policies and guidelines to protect well-being, autonomy and reproductive rights of both stakeholder groups. More empirical research and further theoretical normative analyses are needed to inform people-centred policy and guidelines for shared decision-making concerning the use of EGDs for research.

Oocyte donation in donors with levonorgestrel intrauterine device: a good match?

RESEARCH QUESTION: Does the levonorgestrel-releasing intrauterine device (LNG-IUD) influence cumulative live birth rate (CLBR) in oocyte donor cycles? DESIGN: Retrospective cohort study based on prospectively collected data from 1 May 2009 to 31 December 2017, without attrition, consisting of 491 consecutive cycles of vitrified oocyte donation, none lost to follow-up (unique donor-recipient pairs). All donors underwent ovarian stimulation using gonadotrophin releasing hormone (GnRH) antagonist co-treatment and GnRH agonist trigger. CLBR was chosen as primary outcome measure. RESULTS: In total, 103 (21.0%) cycles were carried out in donors carrying a LNG-IUD. In 388 (79.0%) cycles, no LNG-IUD was present. After confounder-adjustment, the use of an LNG-IUD did not have a statistically significant influence on CLBR. CONCLUSIONS: The LNG-IUD does not negatively affect CLBR.

The current status of oocyte banks: domestic and international perspectives.

Two major breakthroughs in the field of assisted reproduction-oocyte donation and oocyte vitrification-have joined forces to create the rapidly emerging phenomenon of commercial egg banks (CEBs). In this review, we examine the history of this concept, the operational models, the geographical variations, and the benefits and pitfalls of CEBs, including the ethical and legal dilemmas arising from gamete mobility. We highlight future directions in the brave new world of third-party reproduction.

Position statement on West Nile virus: a committee opinion.

Although there is currently no definitive evidence linking West Nile virus (WNV) transmission with reproductive cells, it is recommended that practitioners defer gamete donors who have confirmed or suspected WNV infections. This document replaces the previously published document of the same name, last published in 2016 (Fertil Steril 2016;105:e9-10).

Reproducing whiteness and enacting kin in the Nordic context of transnational egg donation: Matching donors with cross-border traveller recipients in Finland.

The multimillion-euro fertility industry increasingly tailors its treatments to infertile people who are willing to travel across national borders for treatments inaccessible at home, especially reproductive tissue donor treatments. Finland is the Nordic destination for access to donor eggs, particularly for Swedes and Norwegians hoping for a donor match that will achieve a child of phenotypically plausible biological descent. Finns are seen as Nordic kin, and the inheritability of "Nordicness" is reinforced at clinics. Drawing on ethnographic material from three fertility clinics in Finland during 2015-2017, this article discusses how Nordic relatedness and whiteness are enacted in the practices of matching of donors with recipient parents. The analysis shows a selective and exclusionary rationale to matching built around whiteness: matches between donors with dark skin tone and recipients with fair skin tone are rejected, but a match of a donor with fair skin and recipients with dark skin may be made. Within the context of transnational egg donation, the whiteness or Nordicness of Finns is not questioned as it has been in other historical circumstances. Even the establishment of a state donor register offers a guarantee of kin-ness, especially non-Russian kin-ness. It is concluded that the logics of matching protect the "purity" of whiteness but not browness or blackness, enacting Nordic(kin)ness in ways that are part of broader intra-European histories of racism and post-socialist Othering.

Ethical quandaries around expanded carrier screening in third-party reproduction.

Although current screening methods of gamete donors are capable of reducing the incidence of genetic anomalies in donor offspring below general population levels, targeted screening for a large number of conditions (expanded carrier screening or ECS) could be considered as part of the routine selection procedure for gamete donors. There are, however, important drawbacks to its practical implementation. Excluding all carriers of severe recessive monogenic pediatric disorders would disqualify virtually all donors, and other approaches negatively affect cost (and therefore access), present dilemmas in regard to disclosure of genetic findings, and/or overburden the intended parents. In all of the scenarios considered, adequate genetic counseling will be of central importance. Besides looking at benefits and drawbacks of possible ways of implementing ECS, we also examine whether a moral obligation exists to adopt ECS at all and on whose shoulders such an alleged obligation would rest: policymakers, medical staff at fertility clinics, sperm and egg banks, the intended parents? We argue that given the small risk reduction brought about by ECS, the possible negative effects of its implementation, and the absence of widespread preconception carrier screening in the general population, it is inconsistent to argue that there is a moral obligation to perform ECS in the context of donor conception. Finally, implications for the donors are discussed.

Euploidy rates in donor egg cycles significantly differ between fertility centers.

Study question: Do external factors affect euploidy in egg donor cycles? Summary answer: The study demonstrates that during human assisted reproduction, embryonic chromosome abnormalities may be partly iatrogenic. What is known already: Chromosome abnormalities have been linked in the past to culture conditions such as temperature and Ph variations, as well as hormonal stimulation. Those reports were performed with older screening techniques (FISH), or ART methods no longer in use, and the subjects studied were not a homogeneous group. Study design, size, duration: A total of 1645 donor oocyte cycles and 13 282 blastocyst biopsies from 42 fertility clinics were included in this retrospective cohort study. Samples from donor cycles with PGS attempted between September 2011 and July 2015 were included. Participants/materials, setting, methods: PGS cycles from multiple fertility clinics referred to Reprogenetics (Livingston, NJ) that involved only oocyte donation were included in this study. Testing was performed by array comparative genomic hybridization (aCGH). Ploidy data were analyzed using Generalized Linear Mixed Models with logistic regression using a logit link function considering a number of variables that represent fixed and random effects. Main results and the role of chance: Euploidy rate was associated with the referring center and independent of almost all the parameters examined except donor age and testing technology. Average euploidy rate per center ranged from 39.5 to 82.5%. The mean expected rate of euploidy was 68.4%, but there are variations in this rate associated with the center effect. Limitations, reasons for caution: Data set does not include details of the donor selection process, donor race or ethnic origin, ovarian reserve or ovarian responsiveness. Due to the retrospective nature of the study, associations are apparent, however, causality cannot be established. Discrepancies in regard to completeness and homogeneity of data exist due to data collection from over 40 different clinics. Wider implications of the findings: This is the first study to show a strong association between center-specific ART treatment practices and the incidence of chromosome abnormality in human embryos, although the meiotic or mitotic origin of these abnormalities could not be determined using these technologies. Given the widespread applications of ART in both subfertile and fertile populations, our findings should be of interest to the medical community in general as well as the ART community in particular. Study funding/competing interest(s): No external funds were used for this study. S. Munne is a founding principle of Reprogenetics/current employee of Cooper Genomics. M Alikani's spouse is a founding principle of Reprogenetics/current consultant for Cooper Genomics. The remaining authors have no conflicts to declare.

Do donor oocyte cycles comply with ASRM/SART embryo transfer guidelines? An analysis of 13,393 donor cycles from the SART registry.

OBJECTIVE: To analyze donor oocyte cycles in the Society for Assisted Reproductive Technology (SART) registry to determine: 1) how many cycles complied with the 2009 American Society for Reproductive Medicine/SART embryo transfer guidelines; and 2) cycle outcomes according to the number of embryos transferred. For donor oocyte IVF with donor age <35 years, the consideration of single-embryo transfer was strongly recommended. DESIGN: Retrospective cohort study of United States national registry information. SETTING: Not applicable. PATIENT(S): A total of 13,393 donor-recipient cycles from 2011 to 2012. INTERVENTION(S): Embryos transferred in donor IVF cycles. MAIN OUTCOME MEASURE(S): Percentage of compliant cycles, multiple pregnancy rate. RESULT(S): There were 3,157 donor cleavage-stage transfers and 10,236 donor blastocyst transfers. In the cleavage-stage cycles, 88% met compliance criteria. The multiple pregnancy rate (MPR) was significantly higher in the noncompliant cycles. In a subanalysis of compliant cleavage-stage cycles, 91% transferred two embryos and only 9% single embryos. In those patients transferring two embryos, the MPR was significantly higher (33% vs. 1%). In blastocyst transfers, only 28% of the cycles met compliance criteria. The MPR was significantly higher in the noncompliant blastocyst cohort at 53% (compared with 2% in compliant cycles). CONCLUSION(S): The majority of donor cleavage-stage transfers are compliant with current guidelines, but the transfer of two embryos results in a significantly higher MPR compared with single-embryo transfer. The majority of donor blastocyst cycles are noncompliant, which appears to be driving an unacceptably high MPR in these cycles.

Position on reproductive donors and smallpox vaccine: a committee opinion.

Although there is presently no definitive evidence linking vaccinia virus transmission through reproductive cells, the Society for Assisted Reproductive Technology (SART) and the American Society for Reproductive Medicine (ASRM) accordingly recommend that assisted reproductive technology (ART) practitioners consider deferring individuals who are planning on donating gametes for reproductive use (reproductive donors) who have recently received smallpox vaccine or contracted symptomatic vaccinia virus infection through close contact with a vaccine recipient (until after the vaccine or infectious scab has spontaneously separated). Good donor practice further suggests that reproductive donors who are not in good health, including those with recent complications from smallpox vaccine, should be similarly deferred. This document replaces the previous document of the same name last published in 2012 (Fertil Steril 2012;98:e1-e2).

Position statement on West Nile virus: a committee opinion.

Although there is currently no definitive evidence linking West Nile virus (WNV) transmission with reproductive cells, it is recommended that practitioners defer gamete donors who have confirmed or suspected WNV infections. This document replaces the previously published document of the same name, last published in 2012 (Fertil Steril 2012;98:e15-6).

Financial compensation of oocyte donors: an Ethics Committee opinion.

Financial compensation of women donating oocytes for infertility therapy or for research is justified on ethical grounds and should acknowledge the time, inconvenience, and discomfort associated with screening, ovarian stimulation, and oocyte retrieval, and not vary according to the planned use of the oocytes, the number or quality of oocytes retrieved, the number or outcome of prior donation cycles, or the donor's ethnic or other personal characteristics. This document replaces the document of the same name, last published in 2007 (Fertil Steril 2007;88:305-9).

Establishment of comparative performance criteria for IVF centers: correlation of live birth rates in autologous and donor oocyte IVF cycles.

BACKGROUND: To assess whether an objective performance criterion for in vitro fertilization (IVF) centers can be established. METHODS: A retrospective analysis of 2011 National ART Surveillance System data for 451 U.S. IVF centers, 137 of which were included in the analysis since they performed >20 fresh embryo transfers per age group and >20 fresh oocyte donor transfers. The analysis of autologous cycles was restricted to women under age 40. The main outcome measure was correlation between center-specific live birth rates (LBR) in autologous and donor oocyte cycles. RESULTS: 55.6% donor and 46.7%, 39.1% and 28.7% (for ages <35, 35-37 and 38-40 years) autologous cycles resulted in live births per fresh embryo transfer. Donor LBR predicted autologous LBR (< 35 years, P < 0.001; 35 - 38 years, P < 0.001; 38 - 40 years, P = 0.015). Clinics with high prevalence of patients with diminished ovarian reserve had lower autologous LBR per age group (P = 0.015). Every 10% increase in donor LBR increased odds of autologous LBR above the age-adjusted national average by 68% (OR 1.68; 95% CI 1.36 - 2.07; P < 0.001). CONCLUSIONS: Since center-specific donor and autologous IVF cycle outcomes correlate, and as donor cycles reflect fewer patient covariates, they represent a first comparable performance measure between centers, allowing for internal as well as external quality control.

Repetitive oocyte donation: a committee opinion.

This Committee Opinion concludes that donors be advised of the number of cycles/donations that a given oocyte donor may undergo. Although existing data cannot permit conclusive recommendations, a concern for the issues of the safety and well-being of oocyte donors warrants consideration. This document replaces the document of the same name, previously published in 2008 (Fertil Steril 2008; 90:S194-5).