Development of the Tool to Empower Parental Telling and Talking (TELL Tool): A digital decision aid intervention about children's origins from donated gametes or embryos.

Objective: This study aimed to create and develop a well-designed, theoretically driven, evidence-based, digital, decision Tool to Empower Parental Telling and Talking (TELL Tool) prototype. Methods: This developmental study used an inclusive, systematic, and iterative process to formulate a prototype TELL Tool: the first digital decision aid for parents who have children 1 to 16 years of age and used donated gametes or embryos to establish their families. Recommendations from the International Patient Decision Aids Standards Collaboration and from experts in decision aid development, digital health interventions, design thinking, and instructional design guided the process. Results: The extensive developmental process incorporated researchers, clinicians, parents, children, and other stakeholders, including donor-conceived adults. We determined the scope and target audience of the decision aid and formed a steering group. During design work, we used the decision-making process model as the guiding framework for selecting content. Parents' views and decisional needs were incorporated into the prototype through empirical research and review, appraisal, and synthesis of the literature. Clinicians' perspectives and insights were also incorporated. We used the experiential learning theory to guide the delivery of the content through a digital distribution plan. Following creation of initial content, including storyboards and scripts, an early prototype was redrafted and redesigned based on feedback from the steering group. A final TELL Tool prototype was then developed for alpha testing. Conclusions: Detailing our early developmental processes provides transparency that can benefit the donor-conceived community as well as clinicians and researchers, especially those designing digital decision aids. Future research to evaluate the efficacy of the TELL Tool is planned.

Disposition of unused cryopreserved embryos: opportunities and liabilities.

Cryopreservation of embryos has become an essential aspect of assisted reproductive technology, allowing for greater clinical efficiency and increased safety. However, the increasing numbers of cryopreserved embryos in clinics worldwide pose challenges to all stakeholders with respect to the disposition and donation of one's embryos when the gamete providers have completed their family building. The following series of articles provides an update of outcomes, challenges, and controversies related to embryo disposition. The first article describes the current and future medical potential of donated embryos for human stem cell research and other applications. Second, the practice of embryo donation to other intended parent(s) is summarized, and a review of the literature on child outcomes is presented. Third, the logistics and programmatic steps in managing embryos designated for disposal are discussed, including the option for compassionate transfer. Fourth, legal experts summarize precedent setting cases in the United States and the current legal environment of unused embryo management in the setting of the recent Supreme Court decision in Dobbs v. Jackson Women's Health Organization.

Alpha Test of the Donor Conception Tool to Empower Parental Telling and Talking.

OBJECTIVE: To conduct an alpha test of the prototype of a digital decision aid to help parents disclose donor conception to their children, the Donor Conception Tool to Empower Parental Telling and Talking (TELL Tool). DESIGN: Convergent mixed-methods design. SETTING: Virtual interviews in places convenient to the participants. PARTICIPANTS: A purposeful sample (N = 16) of nine gamete-donor and embryo-recipient parents and eight clinicians, as one parent was also a clinician. METHODS: We conducted cognitive interviews to explore participants' perceptions about the TELL Tool prototype and observe patterns of use. The International Patient Decision Aid Standards (i.e., usability, comprehensibility, and acceptability) guided the development of the qualitative interview guide and directed the qualitative analysis. We also collected data about participants' perceptions and ratings of the helpfulness of each of the prototype's webpages regarding parents' decision making about disclosure. Descriptive statistics were used to analyze the helpfulness ratings before we merged the two data sets to optimize understanding. RESULTS: Participants reported that the TELL Tool was a helpful digital decision aid to help parents tell their children how they were conceived. Most (93.7%) webpage rating scores indicated that the content was very helpful or helpful. The participants identified content and technical areas that needed refinement and provided specific recommendations such as adding concise instructions (usability), tailoring adolescent language (comprehensibility), and softening verbiage (acceptability). CONCLUSION: Alpha testing guided by the International Patient Decision Aid standards was an essential step in refining and improving the TELL Tool prototype before beta testing.

Disposition preferences in oocyte preservation patients.

PURPOSE: To characterize the frozen oocyte disposition preferences of patients undergoing medical and planned fertility preservation. METHODS: All oocyte cryopreservation (OC) patients were identified between 2015 and 2018. Demographic information and fertility preservation (FP) indication (medical or planned) were identified for each patient. Oocyte disposition options included disposal, donation to research, or donation to a specified third party, which was decided at the time of initial consent and made available in the electronic medical record. The primary outcome was the disposition selection. Secondary outcomes included differences in demographic variables and disposition selections between medical and planned FP patients using chi-squared analysis. RESULTS: A total of 336 OC patients with a documented oocyte disposition preference were identified in the study timeframe. Patients were on average 34.5 years old (SD = 5.1) and were predominantly White (70.2%), nulliparous (83.0%), with a BMI of 24.7 (SD = 5.4). A total of 101 patients underwent OC for medical FP and 235 for planned FP. In both groups, the most commonly selected disposition option was donation to research (50% planned, 52% medical), followed by donation to a specified third party (30% planned, 30% medical), and finally disposal of oocytes (20% planned, 18% medical). There were no significant differences in disposition selection between each group. When comparing patient variables between groups, medical FP patients were more likely to be under the age of 35 and were less likely to be nulliparous (p < .001). CONCLUSION: This study shows that oocyte disposition choices are similar in patients undergoing OC for medical and planned indications. As donation to research was the most commonly selected option in both groups, it is time to start thinking of streamlining ways to utilize this potential research material in the future.

Parents' experiences telling children conceived by gamete and embryo donation about their genetic origins.

OBJECTIVE: To gain an in-depth understanding of parents' experiences telling children conceived by gamete and embryo donation about their genetic origins. DESIGN: Qualitative, descriptive. SETTING: Families' homes. PATIENTS: Gamete or embryo donation recipient parents living in the United States and who told their children, from birth to 16 years, about their genetic origins. INTERVENTIONS: Individual semistructured (n = 12) or dyadic (n = 2) parent interviews. MAIN OUTCOME MEASURES: Directed qualitative content analysis. RESULTS: Fourteen families that comprised 16 gamete or embryo donation recipient parents and represented 24 donor-conceived children between the ages of 4 months and 16 years participated in the study. Single parents (n = 3) and both parents in most two-parent families (n = 9) led the initial telling conversations. Parents recounted personal short stories using language that was both developmentally and medically appropriate. Multiple strategies, including children's books, were used by parents to aid them in their telling. The oldest donor-conceived children in each family were first informed of their genetic origins at birth (n = 10 families) or at 6 months (n = 1 family; "practice runs") or from 3.5 to 12 years (n = 3 families). The telling conversations took place during routine family activities that naturally brought parents and children in close proximity, usually in the home. CONCLUSIONS: Awareness of the nuances of parents' telling conversations with their children through the age of 16 years can help guide clinical counseling and the development of tools to aid parents in their telling conversations.

Predictors and outcomes in breast cancer patients who did or did not pursue fertility preservation.

PURPOSE: Breast cancer is the most common cancer in reproductive age women, and treatment can affect fertility; however, there is often concern regarding the safety of increased estradiol (E2) levels and potential delays in treatment with ovarian stimulation for fertility preservation (FP). The aim of this study was to compare recurrence and survival in breast cancer patients who pursued FP without concurrent letrozole to those who did not (non-FP). METHODS: We reviewed charts of women with breast cancer who contacted the FP patient navigator (PN) at Northwestern University from 01/2005-01/2018. Oncology and fertility outcome data were collected. Data were analyzed by Chi-square test or regression, as appropriate. Kaplan-Meier curves were used to examine breast cancer recurrence and survival. Statistical analyses were performed with SPSS IBM Statistics 26.0 for Windows. RESULTS: 332 patients were included, of which 157 (47.3%) underwent FP. Median days to treatment after consulting the PN was 35 in the FP group and 21 in non-FP (p < 0.05). Cancer recurrence was noted in 7 (4.7%) FP patients and 13 (7.9%) non-FP patients (NS), and mortality in 5 (3.2%) FP patients and 7 (4.2%) non-FP patients (NS). Within the FP group, no significant differences were found in recurrence or mortality based on ER status, age, BMI, peak E2 level or total gonadotropin dose. Likelihood of pursuing FP was primarily a function of age and parity, and was not affected by breast cancer stage. To date, 21 have used cryopreserved specimens, and 13 (62%) had a live birth. CONCLUSIONS: FP is safe and effective in breast cancer patients, regardless of receptor status; E2 elevations and the 2-week delay in treatment start are unlikely to be clinically significant. These findings are unique in that our institution does not use concomitant letrozole during stimulation to minimize E2 elevations in breast cancer patients.

Oocyte donation disclosure decisions: a longitudinal follow-up at middle childhood.

Few studies have captured oocyte donation (OD) parents' decision processes about intended and actual disclosure over time. Likewise, OD children's perceptions about their family composition during middle childhood are underexplored. To address these gaps, a longitudinally followed cohort of OD recipient families was invited to participate in a qualitative, follow-up study. With an 86% response rate after 12 years, families were composed of oocyte recipient mothers (n = 6) and biological fathers (n = 6) representing 12 donor-oocyte conceived children (10.33 ± 1.23 years; mean ± SD). Of the 12 children, two that were aware and two that were unaware of their conceptual origins completed conversational interviews. Only one family in the initial cohort had disclosed OD to their children by the 12-year follow-up, despite 43% of parents intending to disclose and another 43% undecided about disclosure during pregnancy. Four parental disclosure patterns emerged at 12 years: (i) wanting to disclose; (ii) conflicted about disclosure; (iii) not planning to disclose; and (iv) having disclosed. Children that were unaware of their conceptual origins displayed no knowledge of their method of conception. There is a need for family-centric interventions to assist 'wanting to disclose' parents in their disclosure process and 'conflicted about disclosure' parents in their decision-making process post-OD treatment.

Gestational surrogacy: medical, psychosocial, and legal considerations.

Gestational surrogacy can provide an effective family-building method for women whose uterus is absent or dysfunctional and with contraindications to pregnancy, single men, and same-sex male couples. Over the past 30 years, gestational surrogacy cases have represented a growing percentage of third-party reproduction cases, both in the United States and internationally. The following series of articles provides a summary of current topics in optimizing GS arrangements. They focus on medical and psychological screening; psychosocial adjustment of carriers, children, and their families; legal considerations with precedent-setting cases that every clinician should know; and an international overview of cross-border surrogacy.

Ovarian Stimulation Is Safe and Effective for Patients with Gynecologic Cancer.

Purpose: To compare long-term outcomes of gynecologic cancer patients who pursued controlled ovarian hyperstimulation (COH) for fertility preservation (FP) with those who did not. Methods: Retrospective cohort, COH, and health outcomes in gynecologic cancer patients; data were analyzed by chi-square test, t-tests, and logistic regression. Results: Ninety patients with a gynecologic malignancy contacted the FP patient navigator: 45.6% (n = 41) had ovarian cancer, 25.6% (n = 23) endometrial cancer, 18.9% (n = 17) cervical cancer, 5.6% (n = 5) uterine cancer, and 4.4% (n = 4) multiple gynecologic cancers. From this cohort, 32 underwent COH, 43 did not, and 18 pursued ovarian tissue cryopreservation (OTC; 3 patients had both COH and OTC). Median age and type of cancer were not significantly different between the groups. COH patients had a range of 1-35 oocytes retrieved. Days to next cancer treatment in the COH group was 36 days; for those who declined COH, it was 22 days (not significant [NS], p > 0.05). There were two recurrences reported in the stimulation group and four in the no stimulation group (NS). Five deaths were reported, two in the stimulation group, none in the no stimulation group, and three in the OTC group (NS); 34% (n = 11) COH patients returned to use cryopreserved specimens, of which 45% (n = 5) had a live birth. Conclusion: Although time to next treatment was longer in the group of patients who underwent COH, this did not reach statistical significance. It appears that in selected patients with GYN malignancies, COH for oocyte or embryo cryopreservation is safe, with reasonable stimulation outcomes and no difference in long-term outcomes.

Emerging Views of Kinships Created Through Oocyte Donation.

BACKGROUND: The United States has the highest number of oocyte donation cycles, which account for an estimated one-quarter of all worldwide oocyte donation cycles. Although there has been a steady rise in oocyte donation treatment, understanding the kinship views of those intimately involved is lacking. These include women oocyte donors and parents who received donor oocytes to establish a pregnancy. PURPOSE: To explore the views and perspectives about genetic relationships and lineages among women who were oocyte donors and parents who received donated oocytes 10 to 12 years after donors and parents underwent oocyte donation procedures to establish a pregnancy. STUDY DESIGN AND METHODS: A longitudinal cohort of pregnant women who received donor oocytes participated in an expanded, follow-up study 12 years postpregnancy that included the women's heterosexual partners and biological fathers. Women who donated oocytes anonymously 10 to 12 years prior also participated. Qualitative content analysis was used to analyze participants' in-depth interviews. RESULTS: Six women who received donor oocytes and their heterosexual partners and biological fathers (n = 6), representing 12 children conceived by oocyte donation, and 3 women who donated oocytes anonymously representing 3 children participated. Themes that emerged from the women oocyte donors included a reexamination of anonymity and contact with recipient families, managing disclosure to their own children about possible half-siblings, and potential for consanguinity. For recipient parents, there was an overwhelming sense of gratitude to the women oocyte donors, concerns about navigating genetic information gaps, and contemplating future contact with the donors and/or half-siblings. CLINICAL IMPLICATIONS: Nurses can play a vital role in supporting and educating women oocyte donors and recipient parents about navigating complex relationship issues in donor kinships.

Ovarian stimulation is a safe and effective fertility preservation option in the adolescent and young adult population.

PURPOSE: The aim of this study is to describe the multidisciplinary approach and controlled ovarian hyperstimulation (COH) outcomes in adolescent and young adult (AYA) patients (ages 13-21) who underwent oocyte cryopreservation for fertility preservation (FP). METHODS: Multi-site retrospective cohort was performed from 2007 to 2018 at Northwestern University and Michigan University. Data were analyzed by chi-square test, t-test, and logistic regression. RESULTS: Forty-one patients began COH of which 38 patients successfully underwent oocyte retrieval, with mature oocytes obtained and cryopreserved without any adverse outcomes. To treat this group of patients, we use a multidisciplinary approach with a patient navigator. When dividing patients by ages 13-17 vs. 18-21, the median doses of FSH used were 2325 and 2038 IU, the median number of mature oocytes retrieved were 10 and 10, and median number frozen oocytes were 11 and 13, respectively. Median days of stimulation were 10 for both groups. There was no statistical difference in BMI, AMH, peak E2, FSH dosage, days stimulated, total oocytes retrieved, mature oocytes retrieved, and oocytes frozen between the two groups. Three patients were canceled for poor response. CONCLUSION: COH with oocyte cryopreservation is a feasible FP option for AYAs who may not have other alternatives when appropriate precautions are taken, such as proper counseling and having a support team. These promising outcomes correspond to similar findings of recent small case series, providing hope for these patients to have genetically related offspring in the future.

Oocyte donation: lessons from the past, directions for the future.

Oocyte donation has its origins in the clandestine use of donated sperm more than 140 years ago. Since first described in 1983, oocyte donation has resulted in more than 50,000 births in the United States alone and today now accounts for more than 10% of all IVF cycles performed yearly in the United States. The use of donated oocytes has changed the human reproductive landscape, challenging the traditional norms of conception and parenthood. Oocyte donation has also provided a unique scientific model that separates the egg from the uterus, allowing the independent study of each in normal physiologic and pathological conditions and providing insights into the fundamental aspects of reproduction, cell biology, and genetics. This Views and Reviews takes us through the historical development of oocyte donation, its scientific insights, and its application to daily practice and management, as well as insights into what the future may hold for this field.

Long-term outcomes in cancer patients who did or did not pursue fertility preservation.

OBJECTIVE: To compare long-term outcomes of cancer patients who pursued fertility preservation (FP) with those who did not and compare random-start (RS) and menstrual cycle-specific (CS) protocols for FP. DESIGN: Retrospective cohort. SETTING: Single urban academic institution. PATIENT(S): Oncology patients who contacted the FP patient navigator, 2005-2015. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Time to cancer treatment, disease-free survival, and reproductive outcomes in FP versus no-FP patients and cycle outcomes for RS versus CS protocols. Data were analyzed by χ2 and logistic regression. RESULT(S): Of 497 patients who met the inclusion criteria, 41% elected FP. The median number of days to cancer treatment was 33 and 19 days in the FP and no-FP groups, respectively. There was no difference in cancer recurrence or mortality. There were no differences in stimulation parameters, outcomes, or days to next cancer treatment in RS versus CS protocols. Twenty-one patients returned to use cryopreserved specimens, resulting in 16 live births. Eight of 21 returning patients used a gestational carrier. Thirteen FP (6.4%) and 16 no-FP (5.5%) patients experienced a spontaneous pregnancy. CONCLUSION(S): FP is both safe and efficacious for eligible cancer patients. Only 10% of patients returned to use cryopreserved specimens, and almost half used a gestational carrier, suggesting the need for further research into reproductive decision-making in cancer survivors.

Is employer coverage of elective egg freezing coercive?: a survey of medical students' knowledge, intentions, and attitudes towards elective egg freezing and employer coverage.

PURPOSE: The purpose of this study was to understand medical students' knowledge, intentions, and attitudes towards oocyte cryopreservation and employer coverage of such treatment. METHODS: This cross-sectional study was performed via an online cross-sectional survey distributed to 280 female medical students from March through August 2016. Demographics, attitudes towards employer coverage, and factors influencing decision-making were assessed via a self-reported multiple-choice questionnaire. The relationship between respondents' attitudes towards employer coverage and other parameters was analyzed. RESULTS: A total of 99 responses were obtained out of 280 female medical students. Most respondents (71%) would consider oocyte cryopreservation (potential freezers), although 8% would not consider the procedure and 21% were unsure. Seventy-six percent of respondents felt pressure to delay childbearing. Potential freezers were more likely to be single (p = 0.001), to report feeling pressure to delay childbearing (p = 0.016), and to consider egg freezing if offered by an employer (p < 0.001). Importantly, 71% percent did not view employer coverage as coercive and 77% of respondents would not delay childbearing due to employer coverage. Factors influencing decision-making in potential freezers were absence of a suitable partner (83%), likelihood of success (95%), and health of offspring (94%), among others. Knowledge about the low chance of pregnancy per oocyte (6-10%) would influence decision-making in 42% of potential freezers. CONCLUSION: Oocyte freezing is an acceptable strategy for the majority of young women surveyed. Pressure to delay childbearing was related to openness to freeze eggs. The majority of respondents did not find employer coverage for egg freezing coercive although further research is needed with larger, representative samples to ascertain the relationship between pressure to delay childbearing due to work demands and employer coverage for egg freezing.

Blurring the line between life and death: a review of the psychological and ethical concerns related to posthumous-assisted reproduction.

Posthumous-assisted reproduction (PAR), though viewed unfavourably by some, is desirable to many individuals whose partners die prior to the completion of family building. PAR is technically feasible for males and females both pre- and post-mortem and these procedures have previously been completed on numerous occasions. However, such treatment is associated with three primary ethical concerns: autonomy; beneficence; and justice for the living, the deceased, and the soon-to-be conceived. Further, there are many psychological risks of PAR which may affect all involved parties. As such, early psychological counselling of patients and surviving family members is warranted.

When treatment appears futile: the role of the mental health professional and end-of-treatment counseling.

The end of treatment, whether initiated by the medical team or by the patient, represents a difficult transition for the patient. The mental health professional, as part of a multidisciplinary team, can offer important assistance and support to the patient as they move through the end of their infertility treatment. A description of the topics covered in exit counseling is provided, as well as indications for referral.

Psychological Counseling of Female Fertility Preservation Patients.

Young cancer patients are increasingly interested in preserving their fertility prior to undergoing gonadotoxic therapies. Although the medical safety and treatment protocols for fertility preservation have been well documented, limited research has addressed the emotional issues that arise in fertility preservation patients. We briefly review the literature on the psychosocial issues in adult female fertility preservation treatment and describe our experiences within this patient population. Our findings suggest that several important issues to be addressed during the psychological counseling of adult female fertility preservation patients include: (1) preexisting psychological distress in patients undergoing treatment, (2) choice of fertility preservation strategy in the face of an uncertain relationship future, (3) decision making regarding use of third-party reproduction (e.g., sperm/egg donation, gestational surrogacy), (4) treatment expectations regarding pregnancy and miscarriage, (5) ethical issues related to treatment including the creation, cryopreservation, and disposition of embryos/oocytes, and (6) decision regret from patients who declined fertility preservation.

Results of the Minnesota Multiphasic Personality Inventory-2 among gestational surrogacy candidates.

OBJECTIVE: To obtain normative data on the Minnesota Multiphasic Personality Inventory-2 (MMPI-2) personality test for gestational surrogate (GS) candidates. METHODS: A retrospective study was undertaken through chart review of all GS candidates assessed at Shady Grove Fertility Center, Rockville, MD, USA, between June 2007 and December 2009. Participants completed the MMPI-2 test during screening. MMPI-2 scores, demographic information, and screening outcome were retrieved. RESULTS: Among 153 included candidates, 132 (86.3%) were accepted to be a GS, 6 (3.9%) were ruled out because of medical reasons, and 15 (9.8%) were ruled out because of psychological reasons. The mean scores on each of the MMPI-2 scales were within the normal range. A score of more than 65 (the clinical cutoff) was recorded on the L scale for 46 (30.1%) candidates, on the K scale for 61 (39.9%), and on the S scale for 84 (54.9%). Women who were ruled out for psychological reasons had significantly higher mean scores on the validity scales F and L, and on clinical scale 8 than did women who were accepted (P<0.05 for all). CONCLUSION: Most GS candidates are well adjusted and free of psychopathology, but candidates tend to present themselves in an overly positive way.