Dataset Information

Collection of pregnancy outcome records following infertility-challenges and possible solutions.

ABSTRACT:

Purpose

The aim of this study is to report challenges encountered when conducting inter-institutional data collection of obstetric (prenatal and postpartum) and delivery outcomes for research purposes and to propose solutions for enhanced efficiency.

Methods

Data were collected from women who consented to collection of obstetric and delivery records for an observational study of pregnancy and delivery outcomes following infertility treatment. We analyzed key issues relevant to improving efficiency of obstetric and delivery data collection via quantification of effort (such as number of calls and faxes) required to obtain records from different types of obstetric clinics and hospitals before and after utilization of a revised authorization.

Results

At time of analysis, records were successfully collected from 320 of the 451 participants who had delivered. The 320 participants received obstetric care at 63 institutions and delivered at 27 hospitals, with 168 (52.5 %) delivering at institutions other than home facility. At time of consent (8 weeks gestation), 155 of 320 (48.5 %) correctly predicted where they would receive obstetric care and 176 (55 %) where they would delivery. Most facilities (nearly 90 %) rejected our original authorization, but most (90 %) accepted the revised authorization described in this manuscript.

Conclusions

Collecting records is time-consuming but important as over 50 % of our participants received care outside of the home facility. To efficiently collect outside records, we recommend that researchers interested in maternal and neonatal outcomes consider the guidelines outlined in this manuscript. This report also provides strong evidence of the need to develop data sharing through electronic health records for research purposes.

SUBMITTER: Floyd EG

PROVIDER: S-EPMC4974227 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Publications

Collection of pregnancy outcome records following infertility-challenges and possible solutions.

Floyd Erin G EG von Versen-Höynck Frauke F Liu Jing J Chi Yueh-Yun YY Fleischmann Raquel R RR Baker Valerie L VL

Journal of assisted reproduction and genetics 20160526 8

<h4>Purpose</h4>The aim of this study is to report challenges encountered when conducting inter-institutional data collection of obstetric (prenatal and postpartum) and delivery outcomes for research purposes and to propose solutions for enhanced efficiency.<h4>Methods</h4>Data were collected from women who consented to collection of obstetric and delivery records for an observational study of pregnancy and delivery outcomes following infertility treatment. We analyzed key issues relevant to imp ...[more]

PMID: 27230878

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Project description:Study questionWhich transcriptomic alterations in mid-luteal endometrial scratch biopsies, taken prior to the assisted reproductive treatment (ART) treatment cycle are associated with unsuccessful pregnancy?Summary answerDysregulated interleukin-17 (IL-17) pathway components are demonstrated in women who fail to become pregnant after ART.What is known alreadyImplantation failure is now recognised as a critical factor in unexplained infertility and may be an important component of failed ART.Study design, size, durationUsing a prospective longitudinal study design, 29 nulliparous women with unexplained infertility undergoing ART were recruited between October 2016 and February 2018. Mid-luteal stage endometrium and matched serum samples were collected, and patients underwent a single embryo transfer in the subsequent cycle. RNA-seq analysis of endometrial biopsies was performed on the discovery cohort (n = 20).Participants/materials, setting, methodsGene set enrichment analysis of the differentially expressed genes (DEGs) was performed. Endometrium and serum were then prepared for IL-17A analysis by ELISA.Main results and the role of chanceThere were 204 differentially expressed protein-coding genes identified in tissue from women who became pregnant (n = 9) compared with tissue from women who failed to become pregnant (n = 11) (false discovery rate; P < 0.05). Of the 204 DEGs, 166 were decreased while 38 were increased in the pregnant compared to the non-pregnant groups. Gene set enrichment analysis of the DEGs identified an over-representation of IL-17 and Pl3K-Akt signalling pathways. All the DEGs within the IL-17 signalling pathway (MMP3, MMP1, IL1β, LCN2, S100A9 and FOSL1) demonstrated decreased expression in the pregnant group. Serum IL-17 protein levels were increased in the non-pregnant discovery cohort (n = 11) and these findings were confirmed a validation cohort (n = 9).Limitations, reasons for cautionLimitations of our study include the cohort size and the lack of aneuploidy data for the embryos; however, all embryos transferred were single good or top-quality blastocysts.Wider implications of the findingsThese findings demonstrate dysregulated IL-17 pathway components in women who fail to become pregnant after ART. Elevated serum levels of the pro-inflammatory cytokine IL-17 may predict failure of ART in women with unexplained infertility. Future trials of anti-IL-17 therapies in this cohort warrant further investigation.Study funding/competing interest(s)Funding from the UCD Wellcome Institutional Strategic Support Fund, which was financed jointly by University College Dublin and the SFI-HRB-Wellcome Biomedical Research Partnership (ref 204844/Z/16/Z), is acknowledged. The authors have no competing interests.Trial registration numberNA.

Dataset Information

Collection of pregnancy outcome records following infertility-challenges and possible solutions.

Purpose

Methods

Results

Conclusions

Publications

Collection of pregnancy outcome records following infertility-challenges and possible solutions.

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