Fecundability among Danish women with a history of miscarriage: a prospective cohort study

ObjectiveTo examine the association between history of miscarriage and fecundability (the cycle-specific probability of conception).DesignNationwide prospective cohort study using web-based questionnaires.SettingDenmark, 2007–2012.Participants977 women attempting to conceive, not using fertility treatment, and with a reproductive history of only miscarriage or only live birth.Exposure and outcome measuresInformation on previous pregnancy outcomes, including miscarriage, came from self-report or from relevant registries. Participants were followed for up to 12 months or until they reported a pregnancy, stopped trying to conceive or started fertility treatment, whichever came first. We used Kaplan-Meier methods to estimate cumulative probabilities of conception for women whose reproductive history included only miscarriage or only live birth. Using proportional probabilities regression modelling, we computed fecundability ratios (FR) with 95% CI comparing women with a history of only miscarriage with women with a history of only live birth.ResultsAfter adjustment for potential confounders, the cumulative probabilities of conception within 12 cycles of follow-up were 85% (95% CI 81% to 89%) for women with a history of 1 miscarriage, 85% (95% CI 73% to 92%) for women with a history of ≥2 miscarriages and 88% (95% CI 87% to 89%) for women whose reproductive history included only live birth. Adjusted FRs were 0.87 (95% CI 0.71 to 1.07) and 0.65 (95% CI 0.36 to 1.17) for women with a history of 1 and ≥2 miscarriages, respectively.ConclusionsOur results indicate that women with a history of miscarriage may have slightly reduced fecundability compared with women with a history of only live birth. The reduction in fecundability was greater for women with repeated miscarriages, although the estimates were imprecise. Despite a potential delay in conception, women with previous miscarriage may have similar probability of pregnancy by 12 cycles of attempts to women with proven fertility.

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Self-reported periodontitis and fecundability in a population of pregnancy planners

Human Reproduction ◽

10.1093/humrep/deab058 ◽

2021 ◽

Author(s):

J C Bond ◽

L A Wise ◽

S K Willis ◽

J J Yland ◽

E E Hatch ◽

...

Keyword(s):

Sensitivity Analysis ◽

Cohort Study ◽

Child Health ◽

Human Development ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Fertility Treatment ◽

Time To Pregnancy ◽

Chronic Inflammatory Condition ◽

History Of

Abstract STUDY QUESTION Is a history of periodontitis among women associated with reduced fecundability? SUMMARY ANSWER A history of periodontitis, as assessed by three different self-reported measures, may be associated with reduced fecundability. WHAT IS KNOWN ALREADY Periodontitis is a chronic inflammatory condition affecting the hard and soft tissues surrounding the teeth. Few studies have evaluated the association between periodontitis and time to pregnancy, and findings are mixed. It is hypothesized that periodontitis may adversely affect time to pregnancy. STUDY DESIGN, SIZE, DURATION We conducted a prospective cohort study of 2764 female pregnancy planners residing in North America (March 2015–June 2020). PARTICIPANTS/MATERIALS, SETTING, METHODS Eligible participants had been attempting pregnancy for six or fewer menstrual cycles at enrollment and were not using fertility treatment. Women answered questions about their oral health. Pregnancy was ascertained via bi-monthly follow-up questionnaires. We used proportional probabilities regression models to estimate fecundability ratios (FRs) and 95% confidence intervals (CIs) for three different measures indicative of a history of periodontitis: ever diagnosed with periodontitis (N = 265), ever received treatment for periodontitis (N = 299), and ever had an adult tooth become loose on its own (N = 83). We adjusted for potential confounders and precision variables. Women at risk of misclassification of periodontitis diagnosis due to pregnancy-related gingivitis were reclassified in a sensitivity analysis. MAIN RESULTS AND THE ROLE OF CHANCE All three indices of periodontitis may be associated with reduced fecundability. FRs were 0.89 (95% CI 0.75–1.06) comparing women with and without a previous periodontitis diagnosis, 0.79 (95% CI 0.67–0.94) comparing women with and without previous periodontitis treatment, and 0.71 (95% CI 0.44–1.16) comparing women with and without a tooth that became loose. After reclassification of pregnancy-related gingivitis in the sensitivity analysis, the FR for periodontitis diagnosis was 0.83 (95% CI 0.68–1.00). Weaker FRs were observed among parous women as compared with nulliparous women for periodontitis diagnosis and tooth becoming loose, but not for periodontitis treatment. LIMITATIONS, REASONS FOR CAUTION Though we used validated self-report measures of periodontitis, clinical confirmation is the gold standard. These questions may be functioning as markers of different levels of periodontitis severity, but we were unable to measure disease severity in this population. Finally, we cannot eliminate the possibility of unmeasured confounding. WIDER IMPLICATIONS OF THE FINDINGS This is the first preconception prospective cohort study to evaluate the association between self-reported periodontitis and fecundability. Our results indicate that periodontitis may be associated with lower fecundability. STUDY FUNDING/COMPETING INTEREST(S) This work was partially funded by R01HD086742/Eunice Kennedy Shriver National Institute of Child Health and Human Development and R21HD072326/Eunice Kennedy Shriver National Institute of Child Health and Human Development. PRESTO has received in-kind donations from Swiss Precision Diagnostics, Sandstone Diagnostics, FertilityFriend.com, and Kindara.com for primary data collection. L.A.W. is a fibroid consultant for AbbVie, Inc. J.C.B., S.W., J.Y., K.J.R., E.E.H., and B.H. have no conflicts of interest to disclose. TRIAL REGISTRATION NUMBER N/A.

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OP0051 STRUCTURAL ENTHESEAL LESIONS IN PSORIASIS PATIENTS ARE ASSOCIATED WITH AN INCREASED RISK OF PROGRESSION TO PSORIATIC ARTHRITIS - A PROSPECTIVE COHORT STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.1524 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 33.1-34 ◽

Cited By ~ 1

Author(s):

D. Simon ◽

K. Tascilar ◽

A. Kleyer ◽

S. Bayat ◽

E. Kampylafka ◽

...

Keyword(s):

Cohort Study ◽

Psoriatic Arthritis ◽

Musculoskeletal Pain ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Progression Rate ◽

Research Support ◽

Advisory Boards ◽

Kaplan Meier ◽

Increased Risk

Background:We have previously reported that the presence of musculoskeletal pain in psoriasis patients is associated with a higher risk of developing psoriatic arthritis (PsA) (1). Furthermore, a subset of psoriasis patients shows evidence for structural entheseal lesions (SEL) in their hand joints (2), sometimes also referred as “Deep Koebner Phenomenon”, which are highly specific for psoriatic disease and virtually absent in healthy controls, rheumatoid arthritis and hand osteoarthritis patients (2-4). However, it remains unclear whether SEL alone or in combination with musculoskeletal pain are associated with the development of PsA.Objectives:To test whether the presence of SEL in psoriasis patients increases the risk for progression to PsA and how this is related to the presence of musculoskeletal pain.Methods:Psoriasis patients without evidence of PsA were enrolled in a prospective cohort study between 2011 and 2018. All patients underwent baseline assessment of SEL in their 2ndand 3rdMCP joints by high-resolution peripheral quantitative computed tomography (HR-pQCT). The risk of PsA development associated with SEL and arthralgia was explored using survival analyses and multivariable Cox regression models.Results:114 psoriasis patients (72 men/42 women) with a mean (SD) follow-up duration of 28.2 (17.7) months were included, 24 of whom developed PsA (9.7 /100 patient-years, 95%CI 6.2 to 14.5) during the observation period. Patients with SEL (N=41) were at higher risk of developing PsA compared to patients without such lesions (21.4/100 patient-years, 95%CI 12.5 to 34.3, HR 5.10, 95%CI 1.53 to 16.99, p=0.008) (Kaplan Meier plot A). Furthermore, while patients without arthralgia and without SEL had a very low progression rate to PsA (1/29; 3.4%), patients with arthralgia but no SEL showed higher progression (5/33; 15.2%), which was in line with previous observations (1) (Kaplan Meier plot B). Presence of SEL further enhanced the risk for progression to PsA both in the absence (6/16; 37.5%) and presence (6/14; 42.8%) of arthralgia with the highest progression rate in those subjects with both arthralgia and SEL (p<0.001 by log rank test for trend) (Kaplan Meier plot B).Conclusion:Presence of SEL is associated with an increased risk of developing PsA in patients with psoriasis. If used together with pain, SEL allow defining subsets of psoriasis patients with very low and very high risk to develop PsA.References:[1]Faustini F et al. Ann Rheum Dis. 2016;75:2068-2074[2]Simon D et al. Ann Rheum Dis. 2016;75:660-6[3]Finzel S et al. Ann Rheum Dis. 2011;70:122-7[4]Finzel S et al. Arthritis Rheum. 2011;63:1231-6Disclosure of Interests:David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Koray Tascilar: None declared, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, Sara Bayat Speakers bureau: Novartis, Eleni Kampylafka Speakers bureau: Novartis, BMS, Janssen, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Jürgen Rech Consultant of: BMS, Celgene, Novartis, Roche, Chugai, Speakers bureau: AbbVie, Biogen, BMS, Celgene, MSD, Novartis, Roche, Chugai, Pfizer, Lilly, Louis Schuster: None declared, Klaus Engel: None declared, Michael Sticherling Grant/research support from: Novartis, Consultant of: Advisory boards Abbvie, Celgene, Janssen Cilag, Lilly, Pfizer, MSD, Novartis, Amgen, Leo, Sanofi, UCB, Speakers bureau: Abbvie, Celgene, Janssen Cilag, Leo, MSD, Novartis, Pfizer, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB

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Use of Occupation-Based Outcome Measure and Strength-Based Self-Report with Persons with Substance Use Disorders: A Prospective Cohort Study

Occupational Therapy in Mental Health ◽

10.1080/0164212x.2021.1875956 ◽

2021 ◽

pp. 1-16

Author(s):

Jeffrey Sargent ◽

Kristin Valdes

Keyword(s):

Substance Use ◽

Cohort Study ◽

Substance Use Disorders ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Outcome Measure ◽

Self Report ◽

Strength Based

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The SPARKLE registry: protocol for an international prospective cohort study in patients with alpha-mannosidosis

10.21203/rs.2.19376/v2 ◽

2020 ◽

Author(s):

Julia Hennermann ◽

Nathalie Guffon ◽

Federica Cattaneo ◽

Ferdinando Ceravolo ◽

Line Borgwardt ◽

...

Keyword(s):

Cohort Study ◽

Natural History ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Clinical Care ◽

Clinical Manifestations ◽

Routine Clinical Care ◽

Safety Outcomes ◽

History Of

Abstract Background: Alpha-mannosidosis is a lysosomal storage disorder caused by reduced enzymatic activity of alpha-mannosidase. SPARKLE is an alpha-mannosidosis registry intended to obtain long-term safety and effectiveness data on the use of velmanase alfa during routine clinical care in patients with alpha-mannosidosis. It is a post-approval commitment to European marketing authorization for Velmanase alfa (Lamzede®), the first enzyme replacement therapy for the treatment of non-neurologic manifestations in patients with mild to moderate alpha-mannosidosis. In addition, SPARKLE will expand the current understanding of alpha-mannosidosis by collecting data on the clinical manifestations, progression, and natural history of the disease in treated and untreated patients, respectively.Results: The SPARKLE registry is designed as a multicenter, multinational, noninterventional, prospective cohort study of patients with alpha-mannosidosis, starting patient enrollment in 2020. Patients will be followed for up to 15 years. Safety and effectiveness as post-authorization outcomes under routine clinical care in patients with treatment will be evaluated. The primary safety outcomes are the rate of adverse events (anti-velmanase alfa-immunoglobulin G antibody development, infusion-related reactions, and hypersensitivity). Secondary safety outcomes include the evaluation of medical events, change in vital signs, laboratory tests, physical examination, and electrocardiogram results. The primary effectiveness outcome is a global treatment response rate, evaluated as the individual aggregate of single endpoints from pharmacodynamic, functional, and quality of life effectiveness outcomes; secondary effectiveness outcomes are to characterize the population of patients with alpha-mannosidosis with regard to clinical manifestation, progression, and natural history of the disease. Any patient in the European Union with a diagnosis of alpha-mannosidosis who is willing to participate will likely be eligible for inclusion in the registry. Publications to disseminate scientific insights from the registry are planned. Conclusion: This study will provide real-world data on the long-term safety and effectiveness of velmanase alfa in patients with alpha-mannosidosis during routine clinical care and increase the understanding of the natural course, clinical manifestations, and progression of this ultra-rare disease.

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Electrocardiographic Findings of COVID-19 Patients and Their Correlation with Outcome; a Prospective Cohort Study

Frontiers in Emergency Medicine ◽

10.18502/fem.v5i2.5608 ◽

2021 ◽

Author(s):

Mehdi Pishgahi ◽

Mahmoud Yousefifard ◽

Saeed Safari ◽

Fatemeh Ghorbanpouryami

Keyword(s):

Diabetes Mellitus ◽

Cohort Study ◽

Prognostic Factors ◽

Hospital Mortality ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

P Wave ◽

Axis Deviation ◽

T Wave ◽

History Of

Introduction: Being infected with COVID-19 is associated with direct and indirect effects on the cardiopulmonary system and electrocardiography can aid in management of patients through rapid and early identification of these adversities. Objective: The present study was designed aiming to evaluate electrocardiographic changes and their correlation with the outcome of COVID-19 patients. Methods: This Prospective cohort study was carried out on COVID-19 cases admitted to the emergency department of an educational hospital, during late February and March 2020. Electrocardiographic characteristics of patients and their association with in-hospital mortality were investigated. Results: One hundred and nineteen cases with the mean age of 60.52±13.45 (range: 29-89) years were studied (65.5% male). Dysrhythmia was detected in 22 (18.4%) cases. T-wave inversion (28.6%), pulmonale P-wave (19.3%), left axis deviation (19.3%), and ST-segment depression (16.8%) were among the most frequently detected electrocardiographic abnormalities, respectively. Twelve (10.1%) cases died. There was a significant correlation between in-hospital mortality and history of diabetes mellitus (p=0.007), quick SOFA score > 2 (p<0.0001), premature ventricular contraction (PVC) (p=0.003), left axis deviation (LAD) (p=0.039), pulmonale P-wave (p<0.001), biphasic P-wave (p<0.001), inverted T-wave (p=0.002), ST-depression (p=0.027), and atrioventricular (AV) node block (p=0.002). Multivariate cox regression showed that history of diabetes mellitus, and presence of PVC and pulmonale P-wave were independent prognostic factors of mortality. Conclusions: Based on the findings of the present study, 18.4% of COVID-19 patients had presented with some kind of dysrhythmia and in addition to history of diabetes, presence of PVC and pulmonale P-wave were among the independent prognostic factors of mortality in COVID-19 patients.

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The SPARKLE registry: protocol for an international prospective cohort study in patients with alpha-mannosidosis

Orphanet Journal of Rare Diseases ◽

10.1186/s13023-020-01549-8 ◽

2020 ◽

Vol 15 (1) ◽

Author(s):

Julia B. Hennermann ◽

Nathalie Guffon ◽

Federica Cattaneo ◽

Ferdinando Ceravolo ◽

Line Borgwardt ◽

...

Keyword(s):

Cohort Study ◽

Natural History ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Clinical Care ◽

Clinical Manifestations ◽

Routine Clinical Care ◽

Safety Outcomes ◽

History Of

Abstract Background Alpha-mannosidosis is a lysosomal storage disorder caused by reduced enzymatic activity of alpha-mannosidase. SPARKLE is an alpha-mannosidosis registry intended to obtain long-term safety and effectiveness data on the use of velmanase alfa during routine clinical care in patients with alpha-mannosidosis. It is a post-approval commitment to European marketing authorization for Velmanase alfa (Lamzede®), the first enzyme replacement therapy for the treatment of non-neurologic manifestations in patients with mild to moderate alpha-mannosidosis. In addition, SPARKLE will expand the current understanding of alpha-mannosidosis by collecting data on the clinical manifestations, progression, and natural history of the disease in treated and untreated patients, respectively. Results The SPARKLE registry is designed as a multicenter, multinational, noninterventional, prospective cohort study of patients with alpha-mannosidosis, starting patient enrollment in 2020. Patients will be followed for up to 15 years. Safety and effectiveness as post-authorization outcomes under routine clinical care in patients with treatment will be evaluated. The primary safety outcomes are the rate of adverse events (anti-velmanase alfa-immunoglobulin G antibody development, infusion-related reactions, and hypersensitivity). Secondary safety outcomes include the evaluation of medical events, change in vital signs, laboratory tests, physical examination, and electrocardiogram results. The primary effectiveness outcome is a global treatment response rate, evaluated as the individual aggregate of single endpoints from pharmacodynamic, functional, and quality-of-life effectiveness outcomes; secondary effectiveness outcomes are to characterize the population of patients with alpha-mannosidosis with regard to clinical manifestation, progression, and natural history of the disease. Any patient in the European Union with a diagnosis of alpha-mannosidosis who is willing to participate will likely be eligible for inclusion in the registry. Publications to disseminate scientific insights from the registry are planned. Conclusion This study will provide real-world data on the long-term safety and effectiveness of velmanase alfa in patients with alpha-mannosidosis during routine clinical care and increase the understanding of the natural course, clinical manifestations, and progression of this ultra-rare disease.

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Sperm mitochondrial DNA biomarkers and couple fecundity

Human Reproduction ◽

10.1093/humrep/deaa191 ◽

2020 ◽

Vol 35 (11) ◽

pp. 2619-2625

Author(s):

Allyson J Rosati ◽

Brian W Whitcomb ◽

Nicole Brandon ◽

Germaine M Buck Louis ◽

Sunni L Mumford ◽

...

Keyword(s):

Mitochondrial Dna ◽

Cohort Study ◽

General Population ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

National Institutes Of Health ◽

Fertility Treatment ◽

Semen Parameters ◽

Lower Probability ◽

Lower Odds

Abstract STUDY QUESTION Do sperm mitochondrial DNA measures predict probability of pregnancy among couples in the general population? SUMMARY ANSWER Those with high sperm mitochondrial DNA copy number (mtDNAcn) had as much as 50% lower odds of cycle-specific pregnancy, and 18% lower probability of pregnancy within 12 months. WHAT IS KNOWN ALREADY Semen parameters have been found to poorly predict reproductive success yet are the most prevalent diagnostic tool for male infertility. Increased sperm mtDNAcn and mitochondrial DNA deletions (mtDNAdel) have been associated with decreased semen quality and lower odds of fertilization in men seeking fertility treatment. STUDY DESIGN, SIZE, DURATION A population-based prospective cohort study of couples discontinuing contraception to become pregnant recruited from 16 US counties from 2005 to 2009 followed for up to 16 months. PARTICIPANTS/MATERIALS, SETTING, METHODS Sperm mtDNAcn and mtDNAdel from 384 semen samples were assessed via triplex probe-based quantitative PCR. Probability of pregnancy within 1 year was compared by mitochondrial DNA, and discrete-time proportional hazards models were used to evaluate the relations with time-to-pregnancy (TTP) with adjustment for covariates. MAIN RESULTS AND THE ROLE OF CHANCE Higher sperm mtDNAcn was associated with lower pregnancy probability within 12 months and longer TTP. In unadjusted comparisons by quartile (Q), those in Q4 had a pregnancy probability of 63.5% (95% CI: 53.1% to 73.1%) compared to 82.3% (95% CI: 73.2% to 89.9%) for Q1 (P = 0.002). Similar results were observed in survival analyses adjusting for covariates to estimate fecundability odds ratios (FORs) comparing mtDNAcn in quartiles. Relative to those in Q1 of mtDNAcn, FORs (95% CI) were for Q2 of 0.78 (0.52 to 1.16), Q3 of 0.65 (0.44 to 0.96) and Q4 of 0.55 (0.37 to 0.81), and this trend of decreasing fecundability with increasing mtDNAcn quartile was statistically significant (FOR per log mtDNAcn = 0.37; P < 0.001). Sperm mtDNAdel was not associated with TTP. LIMITATIONS, REASONS FOR CAUTION This prospective cohort study consisted primarily of Caucasian men and women and thus large diverse cohorts are necessary to confirm the associations between sperm mtDNAcn and couple pregnancy success in other races/ethnicities. WIDER IMPLICATIONS OF THE FINDINGS Our results demonstrate that sperm mtDNAcn has utility as a biomarker of male reproductive health and probability of pregnancy success in the general population. STUDY FUNDING/COMPETING INTEREST(S) This work was funded in part by the National Institute of Environmental Health Sciences, National Institutes of Health (R01-ES028298; PI: J.R.P.) and the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland (Contracts N01-HD-3-3355, N01-HD-3-3356 and N01-HD-3-3358). The authors declare no competing interests. TRIAL REGISTRATION NUMBER N/A

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