Ethnic and demographic variation in consenting for research in the context of fertility treatment

Abstract STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.

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Cohort profile: CROSS-TRACKS: a population-based open cohort across healthcare sectors in Denmark

BMJ Open ◽

10.1136/bmjopen-2020-039996 ◽

2020 ◽

Vol 10 (10) ◽

pp. e039996

Author(s):

Anders Hammerich Riis ◽

Pia Kjær Kristensen ◽

Matilde Grøndahl Petersen ◽

Ninna Hinchely Ebdrup ◽

Simon Meyer Lauritsen ◽

...

Keyword(s):

Artificial Intelligence ◽

Primary Care ◽

Hospital Admissions ◽

Smoking Status ◽

Population Based ◽

Fertility Treatment ◽

Study Patient ◽

Transfer Payment ◽

Sociodemographic Characteristics ◽

Patient Pathways

PurposeThis paper describes the open cohort CROSS-TRACKS, which comprises population-based data from primary care, secondary care and national registries to study patient pathways and transitions across sectors while adjusting for sociodemographic characteristics.ParticipantsA total of 221 283 individuals resided in the four Danish municipalities that constituted the catchment area of Horsens Regional Hospital in 2012–2018. A total of 96% of the population used primary care, 35% received at least one transfer payment and 66% was in contact with a hospital at least once in the period. Additional clinical information is available for hospital contacts (eg, alcohol intake, smoking status, body mass index and blood pressure). A total of 23% (n=8191) of individuals aged ≥65 years had at least one potentially preventable hospital admission, and 73% (n=5941) of these individuals had more than one.Findings to dateThe cohort is currently used for research projects in epidemiology and artificial intelligence. These projects comprise a prediction model for potentially preventable hospital admissions, a clinical decision support system based on artificial intelligence, prevention of medication errors in the transition between sectors, health behaviour and sociodemographic characteristics of men and women prior to fertility treatment, and a recently published study applying machine learning methods for early detection of sepsis.Future plansThe CROSS-TRACKS cohort will be expanded to comprise the entire Central Denmark Region consisting of 1.3 million residents. The cohort can provide new knowledge on how to best organise interventions across healthcare sectors and prevent potentially preventable hospital admissions. Such knowledge would benefit both the individual citizen and society as a whole.

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Endometrial regeneration with endometrial epithelium: homologous orchestration with endometrial stroma as a feeder

Stem Cell Research & Therapy ◽

10.1186/s13287-021-02188-x ◽

2021 ◽

Vol 12 (1) ◽

Author(s):

Ryo Yokomizo ◽

Yukiko Fujiki ◽

Harue Kishigami ◽

Hiroshi Kishi ◽

Tohru Kiyono ◽

...

Keyword(s):

Epithelial Cells ◽

Stromal Cells ◽

Therapeutic Option ◽

Three Dimensional ◽

Fertility Treatment ◽

Feeder Cells ◽

Endometrial Stromal Cells ◽

Thin Endometrium ◽

Endometrial Epithelial Cells

Abstract Background Thin endometrium adversely affects reproductive success rates with fertility treatment. Autologous transplantation of exogenously prepared endometrium can be a promising therapeutic option for thin endometrium; however, endometrial epithelial cells have limited expansion potential, which needs to be overcome in order to make regenerative medicine a therapeutic strategy for refractory thin endometrium. Here, we aimed to perform long-term culture of endometrial epithelial cells in vitro. Methods We prepared primary human endometrial epithelial cells and endometrial stromal cells and investigated whether endometrial stromal cells and human embryonic stem cell-derived feeder cells could support proliferation of endometrial epithelial cells. We also investigated whether three-dimensional culture can be achieved using thawed endometrial epithelial cells and endometrial stromal cells. Results Co-cultivation with the feeder cells dramatically increased the proliferation rate of the endometrial epithelial cells. We serially passaged the endometrial epithelial cells on mouse embryonic fibroblasts up to passage 6 for 4 months. Among the human-derived feeder cells, endometrial stromal cells exhibited the best feeder activity for proliferation of the endometrial epithelial cells. We continued to propagate the endometrial epithelial cells on endometrial stromal cells up to passage 5 for 81 days. Furthermore, endometrial epithelium and stroma, after the freeze-thaw procedure and sequential culture, were able to establish an endometrial three-dimensional model. Conclusions We herein established a model of in vitro cultured endometrium as a potential therapeutic option for refractory thin endometrium. The three-dimensional culture model with endometrial epithelial and stromal cell orchestration via cytokines, membrane-bound molecules, extracellular matrices, and gap junction will provide a new framework for exploring the mechanisms underlying the phenomenon of implantation. Additionally, modified embryo culture, so-called “in vitro implantation”, will be possible therapeutic approaches in fertility treatment.

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Red spruce seedling gas exchange in response to elevated CO2, water stress, and soil fertility treatments

Canadian Journal of Forest Research ◽

10.1139/x94-125 ◽

1994 ◽

Vol 24 (5) ◽

pp. 954-959 ◽

Cited By ~ 13

Author(s):

L.J. Samuelson ◽

J.R. Seiler

Keyword(s):

Water Stress ◽

Gas Exchange ◽

Soil Fertility ◽

Net Photosynthesis ◽

Growing Season ◽

Red Spruce ◽

Fertility Treatment ◽

Sink Strength ◽

Growth Enhancement ◽

Growing Seasons

The interactive influences of ambient (374 μL•L−1) or elevated (713 μL•L−1) CO2, low or high soil fertility, well-watered or water-stressed treatment, and rooting volume on gas exchange and growth were examined in red spruce (Picearubens Sarg.) grown from seed through two growing seasons. Leaf gas exchange throughout two growing seasons and growth after two growing seasons in response to elevated CO2 were independent of soil fertility and water-stress treatments, and rooting volume. During the first growing season, no reduction in leaf photosynthesis of seedlings grown in elevated CO2 compared with seedlings grown in ambient CO2 was observed when measured at the same CO2 concentration. During the second growing season, net photosynthesis was up to 21% lower for elevated CO2-grown seedlings than for ambient CO2-grown seedlings when measured at 358 μL•L−1. Thus, photosynthetic acclimation to growth in elevated CO2 occurred gradually and was not a function of root-sink strength or soil-fertility treatment. However, net photosynthesis of seedlings grown and measured at an elevated CO2 concentration was still over 2 times greater than the photosynthesis of seedlings grown and measured at an ambient CO2 concentration. Growth enhancement by CO2 was maintained, since seedlings grown in elevated CO2 were 40% larger in both size and weight after two growing seasons.

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