Search

To evaluate the impact of body mass index (BMI) on surgical quality metrics for patients undergoing benign, non-urgent hysterectomy.A multicentre, retrospective review at 7 hospitals in Ontario, Canada (4 academic, 3 community) was conducted. Patients undergoing hysterectomy from July 2016 to June 2019 were included. Hysterectomies for premalignant, malignant and emergency indications were excluded. The primary outcome was a composite of any complication or readmission. Secondary outcomes were grade 2 or greater complication, postoperative emergency department (ED) visit, hospital readmission, operative time (ORT) and estimated blood loss (EBL). Patient characteristics (age, ASA class, preoperative diagnoses, preoperative anemia, prior surgeries), surgical factors (endometriosis, adhesions, hysterectomy route, uterine weight, concomitant procedures, ORT, EBL) and surgeon characteristics (volume, fellowship/generalist training, academic/community hospital) were recorded along with complications, hospital readmissions and ED visits. Outcomes were evaluated using logistic regression and log-regression linear analysis grouping patients by BMI category (normal, overweight, obesity class 1, 2, and 3) and by hysterectomy route (abdominal, laparoscopic, and vaginal).2528 hysterectomies were performed by 67 surgeons. 828 (33%) patients had a normal BMI, 889 (35%) were overweight. 500 (20%) patients had a BMI corresponding to obesity class 1, 205 (8%) class 2 and 106 (4%) class 3. Obese patients had higher ASA class (p .001) and more prior surgeries (p .001) compared to patients with normal BMI. Those with class 2 and 3 obesity were younger (p .001), had greater uterine weight (p .001) and more intra-operative adhesions (p .001). After controlling for covariates, there were no differences in the odds of the primary or secondary outcomes, with the exception of patients with class 2 obesity who underwent vaginal hysterectomy. They had 9.1% (11 min) significantly longer ORT (0.091, 95% CI 0.002-0.18, p .05) and patients with an overweight BMI who underwent vaginal hysterectomy had 28 ml significantly less EBL (-0.154, 95% CI -0.26 to -0.05, p .01) compared to patients with normal BMI.BMI was not independently associated with surgical quality outcomes in patients undergoing hysterectomy for benign, non-urgent indications. Abdominal, laparoscopic, and vaginal hysterectomy can be performed safely in overweight and obese patients.

Evaluate the proportion of justified bilateral salpingo-oophorectomy (BSO) at hysterectomy, based on pathologic diagnosis, and determine prevalence of avoidable BSO based on pre- and intraoperative considerations and pathologic diagnosis.Retrospective review of hysterectomies at seven Ontario, Canada hospitals from 2016 to 2019. Surgeries completed by oncologists or for invasive placentation were excluded. Patient, case, and surgeon characteristics were recorded along with pathologic diagnoses. Avoidable BSO criteria were: preoperative diagnosis of cervical dysplasia or benign diagnosis other than endometriosis, gender dysphoria, risk reduction or premenstrual dysphoric disorder; age51 years; absence of intraoperative endometriosis and adhesions; unjustified pathology (where "justified" pathology was endometriosis or (pre)malignant diagnosis except for cervical dysplasia). Patients with avoidable BSO were compared to those having at least one criterion for BSO. Binary logistic regression identified factors most strongly associated with avoidable BSO.Four thousand one hundred ninety-one hysterectomies were completed with 1,422 (33.9%) patients having concomitant BSO. Pathologic diagnosis justified BSO in most patients (1,035/1,422, 72.8%) with endometrial cancer being most common (439/1,422, 30.9%). When preoperative characteristics, intraoperative findings, and pathologic diagnoses were considered, 79 of 1,422 (5.6%) BSOs were avoidable. Compared to cases with at least one criterion for BSO, avoidable BSOs were more frequently completed by generalists (OR 1.80, 95% CI 1.10-2.99, P = 0.021), for preoperative diagnoses of abnormal uterine bleeding/menorrhagia (OR 3.82, 95% CI 2.35-6.30, P = 0.001) and fibroids (OR 4.25, 95% CI 2.63-6.92, P 0.001).Pathologic diagnosis justified most BSOs at hysterectomy. BSO was avoidable in 5.6% of patients, underscoring the need to standardize practice of BSO.

OBJECTIVE To evaluate predictors of bilateral salpingo-oophorectomy at hysterectomy and determine rate of unnecessary bilateral salpingo-oophorectomy. METHODS Retrospective review of hysterectomies at six Ontario, Canada hospitals from July 2016 to June 2018. Data was extracted from health records coding and electronic medical records. Of patients with concurrent bilateral salpingo-oophorectomy, age, preoperative diagnoses, surgical factors (presence of endometriosis/adhesions), and surgeon training (fellowship/no fellowship) were recorded. Chi-square tests compared indicated and nonindicated bilateral salpingo-oophorectomy cases based on preoperative diagnosis. Criteria for unnecessary bilateral salpingo-oophorectomy were: age under 51 years, benign preoperative diagnosis, and absence of intraoperative endometriosis and adhesions. RESULTS Concurrent bilateral salpingo-oophorectomy occurred in 749/2,656 (28%) cases with 509/749 (68%) indicated based on preoperative diagnosis. There was interhospital variation in rate of indicated bilateral salpingo-oophorectomy based on preoperative diagnosis (45.3%-76.9%, χ2P

Objective To develop and implement a trial of labour after cesarean delivery (TOLAC) bundle—a group of interventions aimed at decreasing cesarean delivery (CD) for women who have had a prior CD (Robson group 5). Methods A TOLAC bundle was developed that included: (1) educational rounds for health care providers, (2) a physician–patient TOLAC discussion aid, and (3) patient-centred educational resources. A before-and-after study design was employed. A one-year chart review determined baseline CD rates in Robson group 5 patients at a tertiary care academic centre. Following this, from February 1, 2018 until May 31, 2019, each bundle intervention was sequentially introduced every four to six months and modified based on provider feedback. Obstetricians were provided with their individual CD rates using an audit-and-feedback approach prior to the introduction of the next intervention. Results The baseline CD rate for Robson group 5 patients was 71% (175/247 eligible patients). Following the introduction of the bundle, the CD rate decreased to 61% (131/214 eligible patients). This was a 10% decrease in the CD rate (P = 0.029). A significant increase in rate of induction was noted, from 5% pre-intervention to 11% post-intervention (p = 0.017). There were no significant decreases in the rate of vaginal birth after CD or increases in the rates of uterine rupture or NICU admission. Conclusions A TOLAC bundle, consisting of provider education, a TOLAC discussion aid, and patient resources, combined with audit and feedback, decreased CD for Robson group 5 patients.

To understand current attitudes and practice patterns of obstetrical care providers regarding trial of labour after cesarean (TOLAC) and to assess misconceptions regarding eligibility for and risks associated with TOLAC.A survey was developed based on published literature, validated by a statistician, and piloted with Canadian obstetricians. French and English versions were distributed via the mailing list of the Society of Obstetricians and Gynaecologists of Canada and social media. Practising obstetrical care providers with an office antenatal practice were eligible to participate. Data were analyzed using descriptive statistics and correlational and multiple regression analyses.A total of 381 people responded, with representation from every Canadian province and territory. Obstetrician-gynaecologists (239, 63%), family physicians (100, 26%), and midwives (42, 11%) responded. Most participants (277, 78%) thought that TOLAC should be actively encouraged. Only 141 (40%) used a decision aid when counselling patients, although most respondents (250, 71%) thought it would be useful. Providers were less comfortable offering oxytocin induction compared with cervical foley or amniotomy (P0.001) and offering TOLAC to patients with an unknown uterine scar (P0.001). Providers in western Canada reported more comfort offering TOLAC to patients with more than 1 previous cesarean delivery compared with other regions. Two hundred nine participants (62%) reported that they had had at least 1 patient with a uterine rupture, with the minority of cases (13, 6%) resulting in litigation.This study offers new information on current national practice patterns and provider attitudes regarding TOLAC. These results can be used to guide future educational initiatives to increase TOLAC rates.

Objectives To understand the current attitudes and practice patterns of prenatal and intrapartum care providers regarding Trial of Labour After Cesarean Section (TOLAC) and to assess misconceptions regarding eligibility and risks of TOLAC. Methods A survey was developed based on published TOLAC literature, validated by a statistician, and piloted amongst university-affiliated faculty. French and English versions were distributed via the SOGC mailing list. Practicing obstetrical care providers with an office antenatal practice were eligible to participate. Data were analyzed using descriptive statistics, correlational and multiple regression analysis. Results The response rate was 33.7% (381/1130 eligible participants) with representation from every Canadian province and territory. Obstetricians/Gynecologists (239, 63%), Family Physicians (100, 26%) and Midwives (42, 11%) responded. Most participants (277, 78%) thought that TOLAC should be actively encouraged. Only 141 (40%) used a decision aid when counselling patients, although the majority of respondents (250, 71%) thought it would be useful. Providers were less comfortable offering oxytocin compared with cervical foley or amniotomy for induction and offering TOLAC to patients with an unknown uterine scar. Providers in Alberta and Saskatchewan reported more comfort offering TOLAC to patients with more than one previous cesarean section compared to other provinces. Two hundred and nine participants (62%) reported that they had at least one patient with a uterine rupture, with the minority (13, 6%) resulting in litigation. Conclusions This study offers new information on current national practice patterns and provider attitudes regarding TOLAC. These results can be used to guide future educational initiatives to increase TOLAC rates.

Objectives To study the efficacy of a trial of labour after caesarean (TOLAC) bundle in decreasing caesarean delivery (CD) rates across five hospitals. Methods Five hospital sites participated, two tertiary-care centres and three community hospitals. Annual delivery rates ranged from 2500 to 7500 per site. A before and after study design was employed. The bundle consisted of three main interventions: (1) education for health care providers, (2) a TOLAC decision aid, and (3) patient educational tools. A one-year chart review determined baseline CD rates in eligible TOLAC patients, according to SOGC guidelines. The bundle interventions were then introduced every four to six months and CD rates were monitored. Obstetrics staff were provided their individual CD rates using an audit-and-feedback approach prior to introduction of the next intervention. Results Baseline CD rate was 77% (1730 out of 2244 eligible patients). Following the introduction of the bundle, the CD rate decreased to 71% (1497 out of 2096 eligible patients). This is a statistically significant 6% decrease in the CD rate, Χ²(1) = 18.29, p Conclusions This TOLAC bundle can decrease CD rates without negatively impacting uterine rupture or NICU admission rates. The interventions can be easily adapted for use in different hospitals and practice environments.

Objective To strengthen the national framework for care of adolescents and women affected by female genital cutting (FGC) in Canada by providing health care professionals with: (1) information intended to strengthen their knowledge and understanding of the practice; (2) directions with regard to the legal issues related to the practice; (3) clinical guidelines for the management of obstetric and gynaecological care, including FGC related complications; and (4) guidance on the provision of culturally competent care to adolescents and women with FGC. Evidence Published literature was retrieved through searches of PubMed, CINAHL, and The Cochrane Library in September 2010 using appropriate controlled vocabulary (e.g., Circumcision, Female) and keywords (e.g., female genital mutilation, clitoridectomy, infibulation). We also searched Social Science Abstracts, Sociological Abstracts, Gender Studies Database, and ProQuest Dissertations and Theses in 2010 and 2011. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to December 2011. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. Values The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1).

Objective A single course of antenatal corticosteroids (ACS) is associated with a reduction in respiratory distress syndrome and neonatal death. Multiple Courses of Antenatal Corticosteroids Study (MACS), a study involving 1858 women, was a multicentre randomized placebo-controlled trial of multiple courses of ACS, given every 14 days until 33+6 weeks or birth, whichever came first. The primary outcome of the study, a composite of neonatal mortality and morbidity, was similar for the multiple ACS and placebo groups (12.9% vs. 12.5%), but infants exposed to multiple courses of ACS weighed less, were shorter, and had smaller head circumferences. Thus for women who remain at increased risk of preterm birth, multiple courses of ACS (every 14 days) are not recommended. Chronic use of corticosteroids is associated with numerous side effects including weight gain and depression The aim of this postpartum assessment was to ascertain if multiple courses of ACS were associated with maternal side effects. Methods Three months postpartum, women who participated in MACS were asked to complete a structured questionnaire that asked about maternal side effects of corticosteroid use during MACS and included the Edinburgh Postnatal Depression Scale Women were also asked to evaluate their study participation Results Of the 1858 women randomized, 1712 (92.1%) completed the postpartum questionnaire. There were no significant differences in the risk of maternal side effects between the two groups. Large numbers of women met the criteria for postpartum depression (14.1% in the ACS vs. 16.0% in the placebo group). Most women (94.1%) responded that they would participate in the trial again. Conclusion In pregnancy, corticosteroids are given to women for fetal lung maturation and for the treatment of various maternal diseases. In this international multicentre randomized controlled trial, multiple courses of ACS (every 14 days) were not associated with maternal side effects, and the majority of women responded that they would participate in such a study again.

Resume Objectif Offrir des conseils aux cliniciens qui participent au processus de choix eclaire en ce qui a trait au don d'embryons humains a des fins de recherche. Recommandations 1.Comme le stipulent les lignes directrices des Instituts de recherche en sante du Canada et la Loi sur la procreation assistee, le consentement explicite tant des donneurs de gametes que des donneurs d'embryons est requis avant que des embryons ne puissent etre utilises a des fins de recherche. Les donneurs de gametes et les fournisseurs d'embryons peuvent ne pas etre les memes personnes lorsque la creation d'embryons fait appel a des dons de gametes. 2.Le processus de consentement doit indiquer ce qui suit aux donneurs potentiels: les types possibles (et, dans le cas du consentement final, le type particulier) de projet de recherche dans le cadre desquels les embryons seront utilises; les risques associes au don d'embryons a la recherche, tel que le risque de ne plus avoir par la suite acces a ces embryons a des fins genesiques; le fait que la femme / le couple ne tireront pas personnellement profit du don d'embryons a la recherche; les gains commerciaux que pourront potentiellement en tirer des tierces parties; la possibilite que l'on communique avec eux a l'avenir au sujet de la disposition des embryons; le fait que la confidentialite ne peut faire l'objet d'une protection absolue. 3.La designation selon laquelle les embryons cryoconserves n'etant plus requis a des fins genesiques doivent etre donnes a la recherche, donnes a un autre couple ou elimines doit faire l'objet d'une discussion avant la recuperation des gametes et etre etablie au moment de la cryoconservation, les personnes concernees comprenant bien que, a l'avenir, un consentement final sera requis. La decision finale quant au don d'embryons cryoconserves ne devrait pas etre prise avant que la femme / le couple n'aient decide qu'ils n'ont plus besoin des embryons en question a des fins genesiques. La decision de mettre fin a la cryoconservation des embryons et la decision quant a leur disposition doivent etre prises separement. La femme / le couple devront etre consultes a nouveau en ce qui a trait a la disposition finale de leurs embryons. 4.Compte tenu du manque de donnees scientifiques quant a la previsibilite de la caracterisation microscopique des embryons et de leur potentiel d'engendrer une grossesse, il est recommande d'offrir a toutes les femmes / tous les couples l'occasion de cryoconserver tous les embryons n'ayant pas ete transferes au cours du cycle de traitement et de les aviser que le fait de ne pas proceder a la cryoconservation de ces embryons peut accroitre leur risque de devoir subir un cycle supplementaire de FIV afin d'atteindre leurs objectifs genesiques. 5.Les participants a la recherche doivent etre avises du fait qu'ils peuvent retirer leur consentement en tout temps avant la decongelation des embryons a des fins de recherche ou, dans le cas de la recherche sur les cellules souches, la creation d'une lignee de cellules souches. 6.Les donneurs potentiels doivent etre avises que leurs soins medicaux ne seront aucunement affectes par leur decision quant au don d'embryons.

Background Postpartum hemorrhage, immediate or delayed, is a leading cause of maternal death. The most common etiologies are retained products of conception, infection, and subinvolution of the placental implantation site. Case A 31-year-old woman, gravida 1, para 0, had an uneventful pregnancy after infertility treatment. She was delivered by intrapartum Caesarean section because of arrest of descent. Twelve days after delivery she had profuse, intermittent vaginal bleeding, but physical examination and pelvic ultrasound failed to reveal the cause. Angiography was performed and showed a left uterine artery pseudoaneurysm that was successfully treated with arterial embolization. Conclusion Use of uterine angiography and embolization at an early stage in the search for the etiology of postpartum hemorrhage helps to decrease morbidity and mortality.

To provide Canadian gynaecologists with evidence-based direction for female genital cosmetic surgery in response to increasing requests for, and availability of, vaginal and vulvar surgeries that fall well outside the traditional realm of medically-indicated reconstructions.Published literature was retrieved through searches of PubMed or MEDLINE, CINAHL, and The Cochrane Library in 2011 and 2012 using appropriate controlled vocabulary and key words (female genital cosmetic surgery). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to May 2012. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies.The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table). Recommendations 1. The obstetrician and gynaecologist should play an important role in helping women to understand their anatomy and to respect individual variations. (III-A) 2. For women who present with requests for vaginal cosmetic procedures, a complete medical, sexual, and gynaecologic history should be obtained and the absence of any major sexual or psychological dysfunction should be ascertained. Any possibility of coercion or exploitation should be ruled out. (III-B) 3. Counselling should be a priority for women requesting female genital cosmetic surgery. Topics should include normal variation and physiological changes over the lifespan, as well as the possibility of unintended consequences of cosmetic surgery to the genital area. The lack of evidence regarding outcomes and the lack of data on the impact of subsequent changes during pregnancy or menopause should also be discussed and considered part of the informed consent process. (III-L) 4. There is little evidence to support any of the female genital cosmetic surgeries in terms of improvement to sexual satisfaction or self-image. Physicians choosing to proceed with these cosmetic procedures should not promote these surgeries for the enhancement of sexual function and advertising of female genital cosmetic surgical procedures should be avoided (III-L) 5. Physicians who see adolescents requesting female genital cosmetic surgery require additional expertise in counselling adolescents. Such procedures should not be offered until complete maturity including genital maturity, and parental consent is not required at that time. (III-L) 6. Non-medical terms, including but not restricted to vaginal rejuvenation, clitoral resurfacing, and G-spot enhancement, should be recognized as marketing terms only, with no medical origin; therefore they cannot be scientifically evaluated. (III-L).

gynaecological laparoscopy is being used increasingly for major operative procedures. Although laparoscopy is considered to be minimally invasive surgery, it does not carry a minimal risk. One of the best ways to avoid complications is to recognize those situations in which they are most likely to occur. Most commonly, complications occur during the set-up phase of laparoscopic surgery, with the establishment of pneumoperitoneum and the insertion of the primary trocar. Intra-operative injuries have also been reported and include vascular, gastro-intestinal tract and urinary tract damage. We present a review addressing the prevention, recognition and management of these complications.

Resume Objectif Fournir aux gynecologues canadiens des directives factuelles en matiere de chirurgie esthetique genitale chez la femme, en reponse au nombre grandissant de demandes (et d'interventions) de chirurgie vaginale et vulvaire se situant bien au-dela des reconstructions traditionnellement indiquees sur le plan medical. Resultats La litterature publiee a ete recuperee par l'intermediaire de recherches menees dans PubMed ou MEDLINE, CINAHL et The Cochrane Library en 2011 et en 2012 au moyen d'un vocabulaire controle et de mots cles appropries (« female genital cosmetic surgery »). Les resultats ont ete restreints aux analyses systematiques, aux essais comparatifs randomises / essais cliniques comparatifs et aux etudes observationnelles. Aucune restriction n'a ete appliquee en matiere de date ou de langue. Les recherches ont ete mises a jour de facon reguliere et integrees a la directive clinique jusqu'en mai 2012. La litterature grise (non publiee) a ete identifiee par l'intermediaire de recherches menees dans les sites Web d'organismes s'interessant a l'evaluation des technologies dans le domaine de la sante et d'organismes connexes, dans des collections de directives cliniques, dans des registres d'essais cliniques et aupres de societes de specialite medicale nationales et internationales. Valeurs La qualite des resultats est evaluee au moyen des criteres decrits dans le rapport du Groupe d'etude canadien sur les soins de sante preventifs (Tableau). Recommandations 1.Un des roles importants des obstetriciens-gynecologues devrait consister a aider les femmes a comprendre leur anatomie et a en respecter les variantes qui leur sont propres. (III-A) 2.Lorsqu'une femme demande la tenue d'interventions esthetiques vaginales, une anamnese medicale, sexuelle et gynecologique exhaustive devrait etre obtenue et l'absence de tout dysfonctionnement sexuel ou psychologique majeur devrait etre etablie. La presence possible de coercition ou d'exploitation devrait egalement etre ecartee. (III-B) 3.Le counseling devrait constituer une priorite dans le cas des femmes qui demandent la tenue d'une chirurgie esthetique genitale. Les sujets abordes dans le cadre du counseling devraient comprendre les variations normales et les modifications physiologiques qui se manifestent au cours de la vie, ainsi que la possibilite de connaitre des consequences imprevues a la suite de la tenue d'une chirurgie esthetique visant les organes genitaux. Le manque de donnees en ce qui concerne les issues de la chirurgie et les effets des modifications subsequentes attribuables a la grossesse ou a la menopause devrait egalement faire l'objet de discussions et etre considere comme faisant partie du processus de consentement eclaire. (III-L) 4.Peu de donnees soutiennent l'amelioration de la satisfaction sexuelle ou de l'image de soi qui serait attribuable aux interventions de chirurgie esthetique genitale chez la femme. Les medecins qui choisissent de proceder a de telles interventions esthetiques ne devraient pas en faire la promotion a des fins d'amelioration de la fonction sexuelle; de surcroit, le recours a la publicite pour promouvoir les interventions de chirurgie esthetique genitale chez la femme devrait etre evite. (III-L) 5.Les medecins qui recoivent des demandes de chirurgie esthetique genitale de la part d'adolescentes doivent chercher a obtenir des competences additionnelles en ce qui a trait a l'offre de services de counseling aux adolescentes. De telles interventions chirurgicales ne devraient pas etre offertes avant l'atteinte de la pleine maturite physiologique (y compris la maturite genitale); le consentement parental n'est alors pas requis. (III-L) 6.Les termes non medicaux (y compris, entre autres, le rajeunissement vaginal, le resurfacage clitoridien et l'augmentation du point G) devraient etre reconnus comme n'etant que des termes de marketing, sans aucune origine medicale; ainsi, ils ne peuvent faire l'objet d'une evaluation scientifique. (III-L)

Objective To develop guidance for clinicians participating in the informed choice process with respect to the donation of human embryos for research purposes. Recommendations 1.As indicated in the Canadian Institutes of Health Research Guidelines and the Assisted Human Reproduction Act, specific consent from both the gamete and embryo providers is required before embryos can be used for research purposes. The gamete donors may be different individuals than the embryo providers when donated gametes are used to create embryos. 2.The consent process should inform potential donors of the possible types of (and for final consent, the specific) research project(s) for which the embryos will be used; the risks involved in donating embryos to research, such as not having these embryos available for their reproductive purposes; the fact that the woman/couple will not benefit personally from donating embryos to research; the potential for commercial gain by others; the possibility that they will be contacted in future about the disposition of the embryos; the fact that confidentiality cannot be absolutely guaranteed. 3.Designation of cryopreserved embryos no longer be required for reproductive purposes to be donated to research, donated to another couple, or discarded should be discussed prior to gamete retrieval and made at the time of cryopreservation, with the understanding that in the future, final consent will be requested. The final decision as to the donation of cryopreserved embryos research should not be made until after the woman/ couple decide they no longer require the embryos for their reproductive purposes. The decision to end cryopreservation should be made separately from the decision regarding disposition of the embryos. The woman/couple will have to be re-contacted regarding the final disposition of their embryos. 4.As a result of lack of scientific data regarding the predictability of microscopic characterization of embryos and potential for pregnancy, it is recommended that all women/couples be offered the opportunity to cryopreserve all embryos not transferred during the treatment cycle and be informed that a failure to cryopreserve all embryos may increase the chance of having to undergo an additional in vitro fertilization cycle to achieve reproductive goals. 5.Research participants should be informed that they may withdraw their consent at any time before the embryos are thawed for research purposes, or, in the case of stem cell research, before a stem cell line is created. 6. Potential donors should be informed that their medical care will not be affected by their decision regarding embryo donation.