Embryo Morphokinetics and Blastocyst Development After GnRH Agonist versus hCG Triggering in Normo-ovulatory Women: a Secondary Analysis of a Multicenter Randomized Controlled Trial

TPS395 Background: Epidemiological studies showed an association between GnRH agonists and a long-term increased risk of CVD, early after treatment initiation and with a higher risk seen in pts with pre-existing CVD. Retrospective pooled safety analyses of 6 randomized trials showed that significantly fewer pts treated with the GnRH receptor antagonists, degarelix, had a CV event or death compared with pts receiving a GnRH receptor agonist. In those studies showing an increased CV risk, Androgen-Deprivation Therapy (ADT) was primarily with GnRH receptor agonists. The mechanistic differences between GnRH antagonists and agonists, including testosterone surge and time to suppression at initiation, effect on follicle-stimulating hormone and on GnRH receptors e.g. T-lymphocytes in atherosclerotic plaque, raises the possibility of different CV risk profiles. The PRONOUNCE trial is the first to prospectively assess whether a GnRH agonist/antagonist can worsen pre-existing CVD; assess the impact of GnRH agonist/antagonist on CV risk biomarkers; and effects of hormonal therapy on immune system. Methods: PRONOUNCE is a multi-center, randomized, controlled trial of 900 men with pc and concomitant CVD, assessing adjudicated MACEs, i.e. myocardial infarction (fatal, non-fatal), stroke (fatal, non-fatal), or death in pts randomized 1:1 to either degarelix or leuprolide according to label recommendations for up to one year. Eligibility include pre-defined CVD, metastatic or locally advanced pc; high-risk disease with plan for definitive radiation therapy (RT); recurrence after local therapy with PSA doubling time <12 months; or salvage RT with neoadjuvant/adjuvant ADT for at least 12 months. Serum samples are collected for the analysis of various CV, inflammatory, and immune biomarkers. The primary endpoint will be based on Kaplan-Meier estimator of survival function and stratified for age group and region. Interim analysis is scheduled when 50% of MACE events have occurred allowing the DSMB to recommend for sample size correction. Clinical trial information: NCT02663908.

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Initial Effects of Electroacupuncture for Chronic Severe Functional Constipation and the Potential Underlying Factors: Secondary Analysis of a Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2019/7457219 ◽

2019 ◽

Vol 2019 ◽

pp. 1-6

Author(s):

Yuxiao Zeng ◽

Yan Liu ◽

Sixing Liu ◽

Zhishun Liu

Keyword(s):

Randomized Controlled Trial ◽

Clinical Response ◽

Controlled Trial ◽

Secondary Analysis ◽

Functional Constipation ◽

Initial Response ◽

Randomized Controlled ◽

Younger Age ◽

Multicenter Randomized Controlled Trial ◽

Bowel Movements

Background. Electroacupuncture (EA) has been found to be effective for treating chronic severe functional constipation (CSFC). However, the initial effects of treatment usually affect the acceptability and compliance of patients with chronic disease in particular. Which class of CSFC patients will have a better initial response to EA remains uncertain and requires investigation. Methods. This was a secondary analysis of an original multicenter randomized controlled trial in which patients with CSFC were randomly assigned to receive 28 sessions of EA or sham electroacupuncture (SA) over 8 weeks with 12 weeks of follow-up. The primary outcome, namely, response with complete spontaneous bowel movements (CSBMs), required participants to have ≥ 3 CSBMs and an increase of ≥ 1 CSBM from the baseline over the first week of treatment. Logistic regression analysis with bootstrapping techniques was performed to determine independent factors related to the response. Results. A total of 1051 eligible patients were included in this study of whom 161 patients were classified as responders at week 1. The CSBM response rate was higher in the EA group (17.5%) than in the SA group (13.2%). And the proportion of these 1-week early responders remained to have higher clinical response at the end of 8-week treatment and 12 weeks after treatment. Age and higher baseline CSBMs were related to CSBM response within the first week: with every 1-year increase in age, the likelihood of clinical response was reduced by 1.7% (odds ratio [OR] 0.983, 95% confidence interval [CI] 0.972 to 0.993; P=0.001). The odds of a CSBM response in patients with 1< CSBMs ≤ 2 at baseline were 4.64 times higher than that in patients with CSBMs ≤ 1 (OR 4.64, 95%CI 4.01 to 5.27). Conclusions. EA produced its initial effects within the first week of treatment. And the effects could last until week 8 and week 20. A younger age and higher number of CSBMs at baseline may increase likelihood of a response.

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Vitamin D Status Relates to Reproductive Outcome in Women With Polycystic Ovary Syndrome: Secondary Analysis of a Multicenter Randomized Controlled Trial

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/jc.2015-4352 ◽

2016 ◽

Vol 101 (8) ◽

pp. 3027-3035 ◽

Cited By ~ 31

Author(s):

Lubna Pal ◽

Heping Zhang ◽

Joanne Williams ◽

Nanette F. Santoro ◽

Michael P. Diamond ◽

...

Keyword(s):

Vitamin D ◽

Randomized Controlled Trial ◽

Polycystic Ovary ◽

Controlled Trial ◽

Secondary Analysis ◽

Reproductive Outcome ◽

Vitamin D Status ◽

Ovary Syndrome ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial

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The effect of written information and counseling by an APN on resilience in women with vulvar neoplasia during six months after surgical treatment and the influence of social support, recurrence, and age: A secondary analysis of a multicenter randomized controlled trial, WOMAN-PRO-II

10.21203/rs.2.16848/v1 ◽

2019 ◽

Author(s):

Sabine Kofler ◽

Andrea Kobleder ◽

Stefan Ott ◽

Beate Senn

Keyword(s):

Social Support ◽

Randomized Controlled Trial ◽

Surgical Treatment ◽

Controlled Trial ◽

Secondary Analysis ◽

Advanced Practice ◽

Randomized Controlled ◽

Written Information ◽

Lack Of Information ◽

Multicenter Randomized Controlled Trial

Abstract Background Woman with vulvar neoplasia complain after surgical treatment often about physical and psychological distress. Lack of information and support can influence resilience. Whether an information-related intervention through an advanced practice nurse support resilience and which other factors have an influence on resilience in women with vulvar neoplasia has never been investigated.Methods The aim of this study were (a) to analyse whether counseling based on the WOMAN-PRO-II program compared to written information creates a significant improvement in resilience scores of women with vulvar neoplasia and (b) to identify potential predictors for resilience. A randomized controlled trial was carried out in women with vulvar neoplasia (N = 49) six months after a surgical treatment in four Swiss hospitals and one Austrian hospital. Analyses of resilience and its predictors were performed using a linear mixed model.Results The resilience score did not differ significantly between the two intervention three and six months after randomisation (p=0.759). As significant predictors of resilience, age (b=.04, p=0.001), social support (b=.28, p=0.009), counseling time (b=.03, p=0.018), and local recurrence (b=-.56, p=0.009) could be identified in linear mixed models analyses.Conclusion To promote resilience in women with vulvar neoplasia, the WOMAN-PRO II Program should be further developed. Particularly, social support should be extended, e.g. in form of more frequent consultations. The interrelation between recurrence and resilience needs to be further investigated to provide specific counseling for women with recurrence.

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Poststroke shoulder pain in subacute patients and its correlation with upper limb recovery after robotic or conventional treatment: A secondary analysis of a multicenter randomized controlled trial

International Journal of Stroke ◽

10.1177/1747493020937192 ◽

2020 ◽

pp. 174749302093719

Author(s):

I Aprile ◽

M Germanotta ◽

A Cruciani ◽

C Pecchioli ◽

S Loreti ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Shoulder Pain ◽

Motor Function ◽

Upper Limb ◽

Controlled Trial ◽

Secondary Analysis ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial

Background and aims Poststroke shoulder pain is a common complication. We aimed to investigate the prevalence of poststroke shoulder pain, with attention to the neuropathic component, and the relationship between poststroke shoulder pain and upper limb improvement in motor function, strength, disability, and quality of life after upper limb rehabilitation. Methods This is a secondary analysis of a multicenter randomized controlled trial to compare upper limb conventional or robotic rehabilitation on 224 patients enrolled in eight rehabilitation centers. We assessed poststroke shoulder pain (using the Numerical Rating Scale and the Douleur Neuropathique 4), and upper limb motor function, strength, disability, and quality of life at baseline (T0), after 30 rehabilitation sessions (T1), and three months after the end of rehabilitation (T2). Results A moderate/severe poststroke shoulder pain was reported by 28.9% of patients, while 19.6% of them showed a neuropathic component. At T0, the intensity of pain was higher in women and in patients with neglect syndrome, positively correlated with the time since stroke and disability and negatively correlated with motor function, strength, and the physical aspects of the quality of life. Moderate/severe pain and neuropathic component significantly reduced after both treatments and this reduction was maintained at T2. Finally, the intensity of pain at baseline was negatively correlated with the improvement of upper limb motor function. Conclusions Poststroke shoulder pain negatively impact on motor performance, strength, disability, and physical aspects of the quality of life as well as on upper limb motor recovery; however, it can be reduced after a robotic or a conventional rehabilitation. Therefore, we suggest considering poststroke shoulder pain when planning the rehabilitation intervention.

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