Perceived Feasibility, Acceptability, and Cultural Adaptation for a Mental Health Intervention in Rural Haiti.

Mental healthcare is largely unavailable throughout Haiti, particularly in rural areas. The aim of the current study is to explore perceived feasibility, acceptability, and effectiveness of potential culturally adapted interventions to improve mental health among Haitian women. The study used focus group discussions (n = 12) to explore five potential interventions to promote mental health: individual counseling, income-generating skills training, peer support groups, reproductive health education, and couples' communication training. Findings indicate that individual counseling, support group, and skills training components were generally anticipated to be effective, acceptable, and feasible by both male and female participants. That being said, participants expressed doubts regarding the acceptability of the couples' communication training and reproductive health education due to: a perceived lack of male interest, traditional male and female gender roles, lack of female autonomy, and misconceptions about family planning. Additionally, the feasibility, effectiveness, and acceptability of the components were described as dependent on cost, proximity to participants, and inclusion of a female health promoter that is known in the community. Given the lack of research on intervention approaches in Haiti, particularly those targeting mental health, this study provides a foundation for developing prevention and treatment approaches for mental distress among Haitian women.

Vaginal Self-Sampling for Human Papillomavirus Infection as a Primary Cervical Cancer Screening Tool in a Haitian Population.

BACKGROUND: Human papillomavirus (HPV) testing as primary cervical cancer screening has not been studied in Caribbean women. We tested vaginal self-collection versus physician cervical sampling in a population of Haitian women. METHODS: Participants were screened for high-risk HPV with self-performed vaginal and clinician-collected cervical samples using Hybrid Capture 2 assays (Qiagen, Gaithersburg, MD). Women positive by either method then underwent colposcopy with biopsy of all visible lesions. Sensitivity and positive predictive value were calculated for each sample method compared with biopsy results, with κ statistics performed for agreement. McNemar tests were performed for differences in sensitivity at ≥cervical intraepithelial neoplasia (CIN)-I and ≥CIN-II. RESULTS: Of 1845 women screened, 446 (24.3%) were HPV positive by either method, including 105 (5.7%) only by vaginal swab and 53 (2.9%) only by cervical swab. Vaginal and cervical samples were 91.4% concordant (κ = 0.73 [95% confidence interval, 0.69-0.77], P < 0.001). Overall, 133 HPV-positive women (29.9%) had CIN-I, whereas 32 (7.2%) had ≥CIN-II. The sensitivity of vaginal swabs was similar to cervical swabs for detecting ≥CIN-I (89.1% vs. 87.9%, respectively; P = 0.75) lesions and ≥CIN-II disease (87.5% vs. 96.9%, P = 0.18). Eighteen of 19 cases of CIN-III and invasive cancer were found by both methods. CONCLUSIONS: Human papillomavirus screening via self-collected vaginal swabs or physician-collected cervical swabs are feasible options in this Haitian population. The agreement between cervical and vaginal samples was high, suggesting that vaginal sample-only algorithms for screening could be effective for improving screening rates in this underscreened population.

Improving IVF Utilization with Patient-Centric Artificial Intelligence-Machine Learning (AI/ML): A Retrospective Multicenter Experience.

Objectives: In vitro fertilization (IVF) has the potential to give babies to millions more people globally, yet it continues to be underutilized. We established a globally applicable and locally adaptable IVF prognostics report and framework to support patient-provider counseling and enable validated, data-driven treatment decisions. This study investigates the IVF utilization rates associated with the usage of machine learning, center-specific (MLCS) prognostic reports (the Univfy® report) in provider-patient pre-treatment and IVF counseling. Methods: We used a retrospective cohort comprising 24,238 patients with new patient visits (NPV) from 2016 to 2022 across seven fertility centers in 17 locations in seven US states and Ontario, Canada. We tested the association of Univfy report usage and first intra-uterine insemination (IUI) and/or first IVF usage (a.k.a. conversion) within 180 days, 360 days, and "Ever" of NPV as primary outcomes. Results: Univfy report usage was associated with higher direct IVF conversion (without prior IUI), with odds ratios (OR) 3.13 (95% CI 2.83, 3.46), 2.89 (95% CI 2.63, 3.17), and 2.04 (95% CI 1.90, 2.20) and total IVF conversion (with or without prior IUI), OR 3.41 (95% CI 3.09, 3.75), 3.81 (95% CI 3.49, 4.16), and 2.78 (95% CI 2.59, 2.98) in 180-day, 360-day, and Ever analyses, respectively; p < 0.05. Among patients with Univfy report usage, after accounting for center as a factor, older age was a small yet independent predictor of IVF conversion. Conclusions: Usage of a patient-centric, MLCS-based prognostics report was associated with increased IVF conversion among new fertility patients. Further research to study factors influencing treatment decision making and real-world optimization of patient-centric workflows utilizing the MLCS reports is warranted.

Unmet health needs identified by Haitian women as priorities for attention: a qualitative study.

This 2009 qualitative study investigated Haitian women's most pressing health needs, barriers to meeting those needs and proposed solutions, and how they thought the community and outside organizations should be involved in addressing their needs. The impetus for the study was to get community input into the development of a Family Health Centre in Leogane, Haiti. Individual interviews and focus group discussions were conducted with 52 adult women in six communities surrounding Leogane. The most pressing health needs named by the women were accessible, available and affordable health care, potable water, enough food to eat, improved economy, employment, sanitation and education, including health education. Institutional corruption, lack of infrastructure and social organization, the cost of health care, distance from services and lack of transport as barriers to care were also important themes. The involvement of foreign organizations and local community groups, including grassroots women's groups who would work in the best interests of other women, were identified as the most effective solutions. Organizations seeking to improve women's health care in Haiti should develop services and interventions that prioritize community partnership and leadership, foster partnerships with government, and focus on public health needs.

Towards a field-compatible optical spectroscopic device for cervical cancer screening in resource-limited settings: effects of calibration and pressure.

Quantitative optical spectroscopy has the potential to provide an effective low cost, and portable solution for cervical pre-cancer screening in resource-limited communities. However, clinical studies to validate the use of this technology in resource-limited settings require low power consumption and good quality control that is minimally influenced by the operator or variable environmental conditions in the field. The goal of this study was to evaluate the effects of two sources of potential error: calibration and pressure on the extraction of absorption and scattering properties of normal cervical tissues in a resource-limited setting in Leogane, Haiti. Our results show that self-calibrated measurements improved scattering measurements through real-time correction of system drift, in addition to minimizing the time required for post-calibration. Variations in pressure (tested without the potential confounding effects of calibration error) caused local changes in vasculature and scatterer density that significantly impacted the tissue absorption and scattering properties Future spectroscopic systems intended for clinical use, particularly where operator training is not viable and environmental conditions unpredictable, should incorporate a real-time self-calibration channel and collect diffuse reflectance spectra at a consistent pressure to maximize data integrity.

Human uterine leiomyoma-derived fibroblasts stimulate uterine leiomyoma cell proliferation and collagen type I production, and activate RTKs and TGF beta receptor signaling in coculture.

BACKGROUND: Uterine leiomyomas (fibroids) are benign smooth muscle tumors that often contain an excessive extracellular matrix (ECM). In the present study, we investigated the interactions between human uterine leiomyoma (UtLM) cells and uterine leiomyoma-derived fibroblasts (FB), and their importance in cell growth and ECM protein production using a coculture system. RESULTS: We found enhanced cell proliferation, and elevated levels of ECM collagen type I and insulin-like growth factor-binding protein-3 after coculturing. There was also increased secretion of vascular endothelial growth factor, epidermal growth factor, fibroblast growth factor-2, and platelet derived growth factor A and B in the media of UtLM cells cocultured with FB. Protein arrays revealed increased phosphorylated receptor tyrosine kinases (RTKs) of the above growth factor ligands, and immunoblots showed elevated levels of the RTK downstream effector, phospho-mitogen activated protein kinase 44/42 in cocultured UtLM cells. There was also increased secretion of transforming growth factor-beta 1 and 3, and immunoprecipitated transforming growth factor-beta receptor I from cocultured UtLM cells showed elevated phosphoserine expression. The downstream effectors phospho-small mothers against decapentaplegic -2 and -3 protein (SMAD) levels were also increased in cocultured UtLM cells. However, none of the above effects were seen in normal myometrial cells cocultured with FB. The soluble factors released by tumor-derived fibroblasts and/or UtLM cells, and activation of the growth factor receptors and their pathways stimulated the proliferation of UtLM cells and enhanced the production of ECM proteins. CONCLUSIONS: These data support the importance of interactions between fibroid tumor cells and ECM fibroblasts in vivo, and the role of growth factors, and ECM proteins in the pathogenesis of uterine fibroids.

Transport theory for HIV diffusion through in vivo distributions of topical microbicide gels.

Topical microbicide products are being developed for the prevention of sexually transmitted infections. These include vaginally-applied gels that deliver anti-HIV molecules. Gels may also provide partial barriers that slow virion diffusion from semen to vulnerable epithelium, increasing the time during which anti-HIV molecules can act. To explore the barrier function of microbicide gels, we developed a deterministic mathematical model for HIV diffusion through realistic gel distributions. We applied the model to experimental data for in vivo coating distributions of two vaginal gels in women. Time required for a threshold number of virions to reach the tissue surface was used as a metric for comparing different scenarios. Results delineated how time to threshold increased with increasing gel layer thickness and with decreasing diffusion coefficient. We note that for gel layers with average thickness > approximately 100 microm, the fractional area coated, rather than the gel layer thickness, was the primary determinant of time to threshold. For gel layers < approximately 100 microm, time to threshold was brief, regardless of fractional area coated. Application of the model to vaginal coating data showed little difference in time to threshold between the two gels tested. However, the protocol after gel application (i.e., with or without simulated coitus) had a much more significant effect. This study suggests that gel distribution in layers of thickness >100 microm and fractional area coated >0.8 is critical in determining the ability of the gel to serve as a barrier to HIV diffusion.

Head and Neck Cancer in Haiti: A Case Series from Hopital de L'Universite d'Etat d'Haiti.

This manuscript characterizes the demographics, presenting symptoms and risk factors of patients diagnosed with head and neck cancer at Hopital de L'Universite d'Etat d'Haiti (HUEH), Haiti's single largest healthcare facility. We conducted a prospective study of patients who presented to HUEH between January and March of 2016 with a lesion of the head or neck suspicious for cancer. All patients who met eligibility criteria received a biopsy, which was interpreted by a Haitian pathologist and when the specimen was available was confirmed by a team of pathologists from Stanford University. A total of 34 participants were identified. The biopsy-confirmed diagnoses were squamous cell carcinoma (n=7), benign (n=7), large cell lymphoma (n=2), ameloblastoma (n=2), pleomorphic adenoma (n=1), and adenocarcinoma (n=1). Fourteen patients were unavailable for biopsy. Patients with head and neck cancer had a mean age of 63.4 years, were majority male (62.5%), waited on average 10.9 months to seek medical attention, and most commonly presented with T-stage 3 or higher disease (87.5%). By characterizing patterns of head and neck cancer at HUEH we hope to facilitate efforts to improve early detection, diagnosis, and management of this important public health condition.

Optical imaging and analysis of human vaginal coating by drug delivery gels.

OBJECTIVE: We used a new optical imaging technique to compare human intravaginal coating distributions of Conceptrol (Advanced Care Products, Brunswick, NJ) and Advantage (Columbia Laboratories, Aventuna, FL). These gels are surrogates for future microbicidal gels, differing in molecular structures and biophysical properties. METHODS: For each protocol, a 3-mL gel bolus was inserted to the posterior fornix while the woman was in the supine position. She then either (1) remained supine (10 min); or (2) sat up (1 min), stood up (1 min), sat down (1 min) and returned to supine for a net elapsed time of 10 min. The imaging device is sized/shaped like a phallus, and measurements while the device was inserted provide data that simulate peri-intromission coating. RESULTS: Coating by Advantage was more extensive and uniform than coating by Conceptrol, with smaller bare spots of uncoated epithelium. Change in posture tended to increase extent and uniformity of coating, details differing between gels. CONCLUSIONS: Results are consistent with predictions of mechanistic coating theory, using gel rheological data as inputs.

Progestin-induced apoptosis in the Macaque ovarian epithelium: differential regulation of transforming growth factor-beta.

BACKGROUND: Oral contraceptive (OC) use is associated with a reduced risk of ovarian cancer. An OC component, progestin, induces apoptosis in the primate ovarian epithelium. One regulator of apoptosis is transforming growth factor-beta (TGF-beta). We determined the effect of progestin on TGF-beta expression in the primate ovarian epithelium and examined the relationship between TGF-beta expression and apoptosis. METHODS: Female cynomolgus macaques were randomly assigned to receive a diet for 35 months containing no hormones (n = 20); the OC Triphasil (n = 17); or each of its constituents, ethinyl estradiol (estrogen, n = 20) or levonorgestrel (progestin, n = 18 ), alone. Ovarian sections were immunostained with monoclonal antibodies against TGF-beta1 or TGF-beta2 plus TGF-beta3 (TGF-beta2/3) isoforms. The expression of TGF-beta isoforms in four ovarian compartments (epithelium, oocytes, granulosa cells, and hilar vascular endothelium) was compared among treatment groups. The association between TGF-beta expression and apoptosis, as determined by morphology and histochemistry, was examined in ovarian epithelium. All statistical tests were two-sided. RESULTS: Compared with ovaries from the control and estrogen-only-treated monkeys, the ovaries of progestin-treated monkeys showed 1) a marked decrease in the expression of TGF-beta1 and a concomitant increase in the expression of the TGF-beta2/3 isoforms in the ovarian epithelium (P<.001), 2) an increase in the expression of TGF-beta2/3 in the hilar vascular endothelium (P<.001), and 3) a marked decrease in TGF-beta2/3 expression in granulosa cells (P<.001). The apoptotic index of the ovarian epithelium was highly associated with the change in expression from TGF-beta1 (P<.001) to TGF-beta2/3 (P

Human papillomavirus prevalence in a population of women living in Port-au-Prince and Leogane, Haiti.

BACKGROUND: There have been no published studies of carcinogenic human papillomavirus (HPV)--the necessary cause of cervical cancer--in Haiti, a nation that has one of the greatest burdens of cervical cancer globally. OBJECTIVE: Characterize prevalence of carcinogenic HPV and the prevalence of individual carcinogenic HPV genotypes in women with cervical precancer or cancer, cervical intraepithelial neoplasia grade 2 (CIN2) or more severe (CIN2+). METHODS: Women (n=9,769; aged 25-60 years) were screened for carcinogenic HPV by Hybrid Capture 2 (HC2; Qiagen, Gaithersburg, MD). Carcinogenic HPV positives underwent colposcopy and visible lesions were biopsied. A subset of carcinogenic HPV positives was tested for individual HPV genotypes using a GP5+/6+ assay. RESULTS: The prevalence of carcinogenic HPV was 19.0% (95% confidence interval: 18.4%-19.9%) and decreased with increasing age (ptrend < 0.001). Women with 3 or more sexual partners and who started sex before the age of 18 years had twice the age-adjusted prevalence of carcinogenic HPV of women with one partner and who started sex after the age of 21 (24.3% vs. 12.9%, respectively). HPV16 and HPV35 were the most common HPV genotypes detected in CIN2+ and more common in women with CIN2+ than those without CIN2+. HPV16 and/or HPV18 were detected in 21.0% of CIN2 (n = 42), 46.2% of CIN3 (n = 52), and 80% of cancers (n = 5). CONCLUSIONS: The prevalence of carcinogenic HPV in Haiti was much greater than the prevalence in other Latin American countries. High carcinogenic HPV prevalence and a lack of cervical cancer screening may explain the high burden of cervical cancer in Haiti.

Concentrations of perfluorooctane sulfonate (PFOS) and perfluorooctanoate (PFOA) and their associations with human semen quality measurements.

A total of 256 men were studied to evaluate whether serum concentrations of perfluorooctanoate (PFOA) and perfluorooctane sulfonate (PFOS) impacted semen quality or reproductive hormones. Blood and semen were collected and analyzed for perfluorochemicals and reproductive and thyroid hormones. Semen quality was assessed using standard clinical methods. Linear and logistic modeling was performed with semen profile measurements as outcomes and PFOS and PFOA in semen and plasma as explanatory variables. Adjusting for age, abstinence, and tobacco use, there was no indication that PFOA or PFOS was significantly associated with volume, sperm concentration, percent motility, swim-up motility and concentration, and directional motility (a function of motility and modal progression). Follicle-stimulating hormone was not associated with either PFOA or PFOS. Luteinizing hormone was positively correlated with plasma PFOA and PFOS, but not semen PFOS. Important methodological concerns included the lack of multiple hormonal measurements necessary to address circadian rhythms.

A pilot analytic study of a research-level, lower-cost human papillomavirus 16, 18, and 45 test.

The analytic performance of a low-cost, research-stage DNA test for the most carcinogenic human papillomavirus (HPV) genotypes (HPV16, HPV18, and HPV45) in aggregate was evaluated among carcinogenic HPV-positive women, which might be used to decide who needs immediate colposcopy in low-resource settings ("triage test"). We found that HPV16/18/45 test agreed well with two DNA tests, a GP5+/6+ genotyping assay (Kappa = 0.77) and a quantitative PCR assay (at a cutpoint of 5000 viral copies) (Kappa = 0.87). DNA sequencing on a subset of 16 HPV16/18/45 positive and 16 HPV16/18/45 negative verified the analytic specificity of the research test. It is concluded that the HPV16/18/45 assay is a promising triage test with a minimum detection of approximately 5000 viral copies, the clinically relevant threshold.

A feasibility study to evaluate pelvic peritoneal anatomy with a saline intraperitoneal sonogram (SIPS).

OBJECTIVE: To prove the safety and feasibility of evaluating pelvic anatomy with a new imaging technique called saline intraperitoneal sonogram (SIPS). DESIGN: Prospective clinical case series. SETTING: Outpatient fertility clinic. PATIENT(S): Ten women with unexplained infertility and normal hysterosalpingograms (HSG). Five women with no known risk factors and five women with known risk factors for adhesive disease were enrolled. INTERVENTION(S): Step 1 required performing a sonohysterogram. Step 2 involved directing a 17-g oocyte retrieval needle into a pocket of peritoneal fluid under ultrasound guidance and infusing normal saline. The pelvic anatomy was evaluated with the three-dimensional and four-dimensional mode on pelvic ultrasound. MAIN OUTCOME MEASURE(S): Technical feasibility, safety, time, fluid infusion, and deficit volumes. RESULT(S): All 10 patients successfully completed the protocol. One of the five women with no risk factors for adhesive disease and a normal HSG was discovered to have a unilateral hydrosalpinx and filmy adhesive disease on SIPS. Both findings were confirmed on laparoscopy. Three out of the five women with known risk factors had abnormal SIPS imaging and were confirmed on laparoscopy to have significant adhesive disease. The average procedure time was 45 minutes (±15 minutes). CONCLUSION(S): This study demonstrates that SIPS is a safe, quick, and potentially cost-effective method for evaluating pelvic adhesive disease in an outpatient facility in women with unexplained infertility and a normal HSG.

Heterotopic cervical pregnancy treated with transvaginal ultrasound-guided aspiration resulting in cervical site varices within the myometrium.

OBJECTIVE: To report a case of successful treatment of a heterotopic cervical pregnancy from IVF-embryo transfer and intracytoplasmic sperm injection (ICSI) that resulted in uterine varices at the cervical site. DESIGN: Case report. SETTING: Tertiary university clinical center. PATIENT(S): A 34-year-old with a history of infertility associated with oligospermia who developed a heterotopic cervical pregnancy diagnosed at 7 weeks gestation. INTERVENTION(S): Transvaginal ultrasound (TVS)-guided aspiration of the cervical pregnancy; preoperative placement of bilateral hypogastric artery occlusion balloons; cesarean section. MAIN OUTCOME MEASURE(S): Successful delivery of intrauterine pregnancy; conservation of the uterus. RESULT(S): Successful termination of the cervical site pregnancy was achieved with TVS-guided aspiration. However, the pregnancy was then complicated by development of uterine varices at the cervical site noted on serial obstetric ultrasounds and magnetic resonance imaging (MRI). Successful management of the pregnancy required a multidisciplinary approach and preoperative placement of bilateral hypogastric artery occlusion balloons. A scheduled high fundal classic cesarean section at 37 weeks allowed for safe delivery of a healthy infant. Complete spontaneous resolution of the uterine varices was noted after the delivery. CONCLUSION(S): It is unclear whether residual ectopic tissue contributed to this later complication; however, it cannot be ignored that the locations of the aborted site and the prominence of dilated venous vasculature in this same location suggests a correlation. The interventions applied are reasonable conservative treatments of a cervical heterotopic pregnancy and a management strategy for uterine varices.

Simple vaginal mold for use in the postoperative care of patients with a transverse vaginal septum.

Severe vaginal stenosis is a potentially disabling complication of transverse vaginal septum resection due to the constriction of the resulting circular scar. We describe a vaginal mold that can be easily created by an occupational therapist, and used as a long-term stent of the vagina in young girls.

Ectopic pregnancy in a preexisting hydrosalpinx during a spontaneous pregnancy.

OBJECTIVE: To discuss the possible role of abnormal embryo migration as a cause of ectopic pregnancy during IVF with hydrosalpinges. DESIGN: Case report. SETTING: University-based reproductive endocrinology and fertility clinic. PATIENT(S): A patient presenting with a tubal ectopic pregnancy after spontaneous conception in a preexisting hydrosalpinx. INTERVENTION(S): Laparoscopic salpingectomy. MAIN OUTCOME MEASURE(S): Ultrasound and operative findings. RESULT(S): Case demonstration of abnormal embryo migration into a surgically documented preexisting hydrosalpinx during a spontaneous conception. CONCLUSION(S): The mechanism of increased tubal ectopic pregnancy rates during IVF with hydrosalpinges remains unexplained. This case supports abnormal embryo migration due to the hydrosalpinx as a contributing factor.

Successful pregnancies in patients with estrogenic anovulation after low-dose human chorionic gonadotropin therapy alone following hMG for controlled ovarian hyperstimulation.

OBJECTIVE: To demonstrate that folliculogenesis can be sustained with 200 IU human chorionic gonadotropins (hCG) after FSH-priming and result in pregnancy in women with estrogenic ovulatory dysfunction and risk factors for severe ovarian hyperstimulation syndrome (OHSS). CASE REPORT: Three women with infertility associated with estrogenic ovulatory dysfunction and hyperinsulinemia who appeared to be at high risk for severe OHSS during gonadotropin therapy. INTERVENTIONS: After 10 days of receiving either 150 IU hMG or recombinant FSH, patients were switched to 200 IU hCG/day alone for 2-3 days. 5,000 IU of hCG was then administered followed by either home intercourse, intrauterine insemination or transvaginal oocyte retrieval-embryo transfer. MAIN OUTCOME MEASURES: Endovaginal ultrasound measurement of follicle number and size, serum estradiol levels, symptoms of ovarian hyperstimulation, pregnancy test, and evaluation of pregnancy by transvaginal ultrasound. RESULTS: After discontinuation of hMG or recombinant FSH, serum estradiol concentrations continued to rise, and follicles >14 mm continued to grow during low-dose hCG administration. All women conceived without developing symptoms of OHSS. Pregnancy outcomes achieved include a term singleton delivery, a term twin delivery, and triplets delivered at 31 weeks gestation. CONCLUSION: The use of low-dose hCG alone is sufficient for supporting the late stages of folliculogenesis in women with estrogenic ovulatory dysfunction. This ovulation induction regimen appears to support the follicular growth of larger follicles while decreasing the number of smaller preovulatory follicles, thereby reducing a known risk factor for OHSS. We report on the positive pregnancy outcomes in 3 women with estrogenic ovulatory dysfunction and clinically appeared to be at high risk for developing severe OHSS who safely underwent this protocol.

Redefining the relationship between sperm deoxyribonucleic acid fragmentation as measured by the sperm chromatin structure assay and outcomes of assisted reproductive techniques.

OBJECTIVE: To test the hypothesis that couples with sperm chromatin structure assay (SCSA) DNA fragmentation index (DFI) values >27% would not achieve pregnancy with assisted reproductive techniques (ART) and to investigate how DFI and high DNA stainability (HDS), as measured by the SCSA, affect fertilization, cleavage, implantation, and pregnancy rates in IVF cycles. DESIGN: Prospective clinical study. SETTING: Academic human reproduction laboratory. PATIENT(S): One hundred couples undergoing IVF with conventional insemination or intracytoplasmic sperm injection. INTERVENTION(S): Testing with SCSA was performed by SCSA Diagnostics (Brookings, South Dakota) on a semen aliquot taken from ejaculate used for ART. MAIN OUTCOME MEASURE(S): Relating total DFI and HDS to conventional semen parameters and cycle-specific outcomes after ART. RESULT(S): Nine of nineteen couples achieved clinical pregnancy when DFI was > or =27%, and 2 of 22 couples achieved clinical pregnancy when DFI was < or =9%. One of nine couples achieved clinical pregnancy with HDS >17%. The DFI was negatively correlated with sperm density (r = -0.23, P<.03) and motility (r = -0.55, P<.00), and HDS was negatively correlated with sperm density (r = -0.37, P<.00). CONCLUSION(S): Sperm chromatin structure assay failed to identify elevated DFI thresholds for negative pregnancy outcome after ART. Patients with low DFI (< or =9%) were least likely to become pregnant, which is also contradictory to SCSA marketing, which states that DFIs of < or =15% have excellent fertility potential. Patients with HDS > or =17% had low pregnancy rates, indicating decreased fertility potential, which deserves further investigation. Larger studies are necessary to confirm that low DFI is associated with decreased fertility and, if proved, might redefine the use of the SCSA in evaluating infertility.

Relationship between pre-embryo pronuclear morphology (zygote score) and standard day 2 or 3 embryo morphology with regard to assisted reproductive technique outcomes.

OBJECTIVE: To test the hypothesis that pregnancy rates are low if grade Z1 pre-embryos are not available for transfer and to determine if pronuclear morphology is a better predictor of pregnancy than traditional embryo morphology. DESIGN: Prospective clinical study. SETTING: Academic human reproduction laboratory. PATIENT(S): One hundred couples undergoing IVF with conventional insemination or ICSI. INTERVENTION(S): Embryo quality was assessed using both pre-embryo pronuclear morphology (zygote scoring or Z-scoring) at the time of fertilization evaluation and standard day 2 and day 3 embryo morphology (number of blastomeres and grading based on degree of fragmentation and blastomere size). MAIN OUTCOME MEASURE(S): We tested two decision models, one based on Z-scores and another on morphology, to determine which grading system better predicted pregnancy outcomes in assisted reproductive technique. Zygote score and embryo morphology were measured for all embryos and the transferred embryo pool. Implantation and pregnancy rates resulting from the embryo transfers of all cycles were calculated. RESULT(S): The Z-score distribution of 552 embryos was 27% Z1, 8% Z2, 50% Z3, and 15% Z4. Z1 and Z3 embryos had significantly (P approximately .03) higher quality over Z2 and Z4 embryos. Using the Z-score decision model with Z1 embryos having highest priority for transfer, pregnancy rates were similar between Z1 and Z3 embryos. Using embryo morphology as a decision model, pregnancy rates were highest in transfers containing one or two "best"-quality embryos. CONCLUSION(S): Z1 and Z3 embryos had similar morphology and pregnancy rates. The decision model based on the Z-score model was not better than standard embryo morphology in predicting pregnancy outcome.