NIHRDataInsights/HRCSData huggingface dataset:
Title: BUMP Feasibility Study
Funder: Borne

Abstract: Feasibility study phase of Borne's Uterine Mapping Project (BUMP) comprising a proof of concept study that facilitates a systematic study of the biological interactions across different cells and tissues in the human uterus with the intension of testing and expanding on noval discoveries that can help prevent the onset of preterm birth.

Lay abstract: The study will determine that 1) pregnant women will donate samples to study the uterus in the lead-up to and onset of labour 2) analytical techniques can be applied to those samples which arepractical in a larger study to generate useful information 3) this can be done effectively in collaboration across university campuses. To study the processes leading to labour in normal pregnancy, we need samples from three locations in the uterus. We will recruit women having Caesarean section in their first pregnancy at maternal request and in their second pregnancy because of a difficult first normal delivery. About 20% of women will present in labour, so we can compare ‘in labour’ with ‘before labour’. We will also compare samples from women having first and second pregnancies, as previous births affect the timing and progress of labour. As part of existing cross-university infrastructure, a team of midwives and research technicians at three London hospitals will attend deliveries and process samples for analysis. We will use techniques to examine gene expression and metabolism in a larger number of samples to identify regional and time-linked differences, and in maternal and fetal blood to identify changes in immune cells or placental signals. We will also compare how the uterus differs between women who have or have not had a previous pregnancy. Then, in pilot studies, we will use more detailed and comprehensive techniques to examine gene expression in single cells, and gene expression and cell metabolism in intact tissues on microscope slides.

Research activity codes: 1.1 NORMAL BIOLOGICAL DEVELOPMENT AND FUNCTIONING
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: The effect of early cryoprecipitate transfusion versus routine care in women who develop severe postpartum haemorrhage: A pilot randomised trial (ACROBAT: Administering CRyoprecipitate in Obstetric Bleeding At an earlier Time)
Funder: Barts Charity

Abstract: This project is part of a bigger programme of work in Women?s Health that will aim at performing a pilot trial assessing the feasibility of delivering a large cluster randomised control trial that will compare early cryoprecipitate transfusion with standard care in women who develop severe bleeding during childbirth. The study will assess the feasibility of delivering cryoprecipitate transfusion within 60 minutes of the bleeding; identify the optimal infrastructure pathway and personnel to identify and recruit patients; evaluate the acceptability of intervention to clinicians and patients; obtain women?s views on participation in a cluster trial where individual consent is sought retrospectively, conduct surveys/interviews with clinicians/participants to identify any barriers to consent and participation; and obtain data on primary event rates to help estimate the sample size for the definitive trial. The study will be performed at four hospitals at Barts Health and Homerton.


Research activity codes: 6.1 PHARMACEUTICALS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: United Kingdom Longitudinal Population Cohort Studies of Subfertile Individuals and Children Conceived after Fertility Treatments
Funder: Wellcome Trust

Abstract: Births after assisted reproductive technology (ART), are rising and currently account for 2% of births in the UK and over 8 million individuals worldwide. Nevertheless, there is little research into long term health outcomes of children born after ART or women who undergo treatment. We have reported cancer outcomes in women and children after ART by linking data from the Human Fertilisation and Embryology Authority (HFEA) registry, NHS digital and National Registry for Childhood Tumours. We have also established a large cohort of ART conceived children (86,000) born in England and Wales whose records are now linked to Hospital Episode Statistics (HES). We now propse to use data linkage to address other long term outcomes in infertile couples receiving ART and their children. Our goals are to: 1) Report further child outcomes from the HFEA-HES linkage 2) Link the 302,000 women recorded on the HFEA registry to HES to establish non-cancer health outcomes 3) Undertake a new cohort study of sub-fertile men via the HFEA registry to assess their cancer and other health risks 4) Repeat our women's cancer and child cancer studies with increased person years of follow-up.

Lay abstract: The ability to have children may be linked to general health. We know that chronic conditions such as cancer, diabetes, and obesity are known to affect fertility. However, it is less clear how infertility is linked with future health. Recent research has shown that infertile men and women might be at greater risk of health problems later in life. Treatment details of all women who have had in-vitro fertilisation (IVF) treatment in the UK and their partners, have been recorded since 1991. We have used this data to study the risk of cancer in women after IVF and in their children (conceived after IVF). We now wish to use our experience of working with routinely collected health records to further study other health risks in women and children after IVF, as well as to study long term conditions in men with known infertility.

Research activity codes: 2.1 BIOLOGICAL AND ENDOGENOUS FACTORS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: Micronutrient interventions to improve infant neurocognitive development and growth in early infancy
Funder: Wellcome Trust

Abstract: Undernutrition during the early years of life has a harmful and irreversible impact on child growth and cognitive development. Many of the interventions tested to improve outcomes across infancy have had disappointing or inconsistent impact, a common feature being the absence of any attempts to provide nutritional supplements to infants during the first six months. With increasing evidence of micronutrient deficiencies in this age group, alongside strong evidence that growth and developmental deficits begin before six months, a renewed focus on the micronutrient status of infants is required. Here I propose a randomised efficacy trial of micronutrient supplementation to mothers (during pregnancy or pregnancy and lactation) and infants (birth to six months) in rural Gambia, where rates of micronutrient deficiencies are high. 600 pregnant women (<20 weeks gestation) will be enrolled into one of five trial arms and followed to 12 months post-partum. The primary outcome will be infant brain development at six months, with micronutrient status, growth and neurocognitive development to 12 months as secondary outcomes. This novel research will identify the most efficacious way of improving micronutrient status in infancy, and assess impact on infant developmental outcomes, providing an evidence base for future effectiveness trials and policy recommendations.

Lay abstract: Deficiencies in micronutrients (essential vitamins and minerals) in infants and young children can have a long-lasting impact on growth and development. This is especially relevant in populations with poor diets. However, little research has focused on interventions to improve micronutrient deficiencies in the first six-months of life, during the period when exclusive breastfeeding is recommended. To address this important knowledge gap, I am proposing a randomised trial among women and infants living in sub-Saharan Africa, to determine whether supplementation with micronutrients to mothers (in pregnancy, or pregnancy and lactation) or supplementation to infants directly (while promoting exclusive breastfeeding) will improve infant development across the first 12 months of life. I will test the effect of supplementation on infant brain development, micronutrient status and growth. This novel research will determine the best way to improve infant micronutrient status and developmental outcomes, providing important data for policy considerations.

Research activity codes: 3.3 NUTRITION AND CHEMOPREVENTION
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: The evaluation and development of novel diagnostic methods to understand and prevent placentally-related complications of human pregnancy
Funder: Wellcome Trust

Abstract: Preeclampsia and fetal growth restriction (FGR) are major determinants of the global burden of disease. There is an unmet need for better approaches to screening and intervention for both conditions. Previously, we conducted the Pregnancy Outcome Prediction (POP) study, a prospective cohort study of 4,512 nulliparous women with a singleton pregnancy. The study generated a simple, prospectively defined screening test which is strongly predictive for preeclampsia and FGR at term. The test combines maternal risk factors, ultrasound and measurement of placentally-derived proteins in maternal serum. We aim to perform a second prospective cohort study (POP2), with serial blood sampling and ultrasound scans in ~4,500 unselected nulliparous women. The cohort will be a core resource to address three aims: (1) to identify women who screen high risk by the POP study screening test at 36wkGA and randomise them to early term induction of labour or routine care, (2) to validate novel predictive algorithms for preterm and term disease based on independent associations between preeclampsia and FGR with metabolite, protein and RNA predictors, and (3) to determine whether preeclampsia and FGR are associated with different patterns of methylation and hydroxymethylation of placental DNA and cell free DNA in maternal plasma.

Lay abstract: Trying to identify women at high risk of pregnancy complications has proved problematic. Current methods are relatively crude and perform poorly. We have developed a test which identifies women at high risk of complications at around eight months of pregnancy. We will conduct a trial to see whether this test really works and to see whether we can improve the outcome by inducing labour early. But we also want to collect more blood samples. We have identified new blood tests that might enhance prediction. We also want to evaluate a promising new method, looking to see whether chemical modifications to the DNA in placenta can be seen in maternal blood. The reason for doing more studies to identify new predictors is that we want to develop tests to predict complications earlier in pregnancy, and we want to be able to predict a bigger proportion of complications.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: Overcoming pre-clinical challenges for a next-generation gynaecological drug delivery device which maximises patient comfort and convenience
Funder: Innovate UK

Abstract: Callaly is an ambitious British startup that has successfully developed and commercialised the first major innovation to the tampon in decades: a novel "hybrid" tampon and pantyliner that is the brainchild of a senior British gynaecologist. Called a Tampliner(R), the already multi award-winning product includes enhanced leakage prevention properties and a thin "sheath" that provides a more clean and comfortable user experience. Callaly established UK based manufacturing of the Tampliner last year and has successfully launched commercial sales in the UK and Western Europe. Beyond the use as a period care product, the Tampliner has been identified by the Callaly team and leading gynaecological key opinion leaders as a potential platform for clean, comfortable and convenient vaginal drug delivery. This concept has already been protected with granted patents in various key markets (including the US and EU). The specific application is for the delivery of progesterone for in-vitro fertilisation (IVF) as the user experience can be drastically improved compared to the messy, uncomfortable, and sometimes painful options that are currently prescribed. To further develop the vast potential of the Tampliner re-engineered for the delivery of hormones, Callaly must complete a robust and detailed feasibility project. There are numerous challenges for Callaly to overcome, and this enclosed Smart Grant application helps the team develop the Tampliner as a drug delivery device by achieving these key objectives: * **Drug Release Coating & Scaffold Fabrication:** Select best scaffold material, investigate drug formulation coating methods (i.e. spray, dip, dry) to maximise the viability of the delivery, and fabricate finalised prototypes for laboratory testing. * **Laboratory Feasibility Testing:** Drug release profile testing (HPLC), biocompatibility and sterility testing, functional/mechanical testing, and other evaluation of the finalised prototypes against the PRS. * **Regulatory & Clinical Development Pathway:** Based on the above strategy, consult with expert subcontractors to determine the best regulatory & clinical approval strategy for the IVF indication. Through this project, Callaly will collaborate with experts in drug delivery, materials science, and pharmacology, internationally renowned gynaecologists, and a leading biopharmaceutical laboratory to validate the feasibility of this drug delivery device.


Research activity codes: 5.1 PHARMACEUTICALS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: Microstructured sperm separation to improve assisted reproduction technologies.
Funder: Innovate UK

Abstract: Since the 1970s, male fertility has halved in the developed world and 30-40% percent of all fertility issues stem from poor sperm health and motility. Despite this worrying trend, there is currently no readily available treatment for poor sperm quality, and conventional methods to separate out the highest quality cells can damage the sperm DNA, leading to miscarriage. With our proprietary Sperm Separation technology, Cytoswim Ltd offers a novel way to separate out the most motile and healthiest sperm cells for use in IVF and other assisted reproduction technologies. We have already proven the efficacy of this technology in a laboratory setting, but we need to scale up our production methods, and interface directly with our customers to maximise user-friendliness. Through this project, we will validate our manufacturing methods, and recruit and train employees, and prove that we can produce our chips to the relevant quantity and quality for use in IVF clinics, and obtain clinical approval to bring our chips to market.


Research activity codes: 2.5 RESEARCH DESIGN AND METHODOLOGIES (AETIOLOGY)
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: Novel wearable neurostimulation system to target period pain
Funder: Innovate UK

Abstract: **Problem** It is calculated that 80% of women of reproductive age (1.5bn people worldwide) suffer from period pain at some point in their life. The pain is felt as either intense spasms or dull and constant cramps in the abdomen which can spread to the back and thighs. Most women suffer the pain in silence, however it disrupts their daily and working lives and in extreme cases requires a hysterectomy. Currently, there are no effective, long term, side-effect free treatments to deal with period pain. Most women use over the counter painkillers, often ibuprofen. However, this gives short lasting relief, is ineffective for people with severe pain and can have several side effects if used long term. Other treatments are hormonal contraceptives, surgery or self-help measures, however these have either major side effects, including an increased risk of blood clots and heart attacks, or give limited pain relief. **The Ohmm Solution** This project was born with the intention of giving women around the world control back during their periods. We are developing a novel neurostimulation device, based on extensive scientific evidence that targets the cause of period pain, providing long lasting drug-free pain relief. The device will be worn on top of the painful area, either the abdomen or lower back, and provide pain relief by an anti-inflammatory mechanism. It has been designed in collaboration with period pain sufferers to be small, comfortable, lightweight, discreet and can even be worn while exercising or doing other activities. It is wirelessly controlled by a paired smartphone app, and activated only when it is needed. Ohmm’s treatment can be personalised, allowing the user to select the most effective, comfortable, pain relieving settings. Ohmm gives women the chance to treat their pain whenever they need it in a discreet, customizable way, leaving them free to carry out their daily routines and contribute to society and the economy without fear of period pain.


Research activity codes: 5.3 MEDICAL DEVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: Emm - The Smart Menstrual Solution
Funder: Innovate UK

Abstract: Even though more than 2 billion people in the world menstruate, the selection of menstrual products is limited, and the sector has seen very little innovation and advancement. Our smart menstrual product turns a failing consumer hygiene staple into a working digital health product.


Research activity codes: 5.3 MEDICAL DEVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: autoICSI - Development of an AI-based fully automated Intracytoplasmic Sperm Injection system to improve fertility success
Funder: Innovate UK

Abstract: Myma Medical will collaborate with the University of Birmingham and Cambridge IVF fertility clinic to develop a first-of-its-kind automated Intracytoplasmic Sperm Injection (ICSI) system to improve fertility treatments. "autoICSI" will use robotics, vision recognition and AI to minimise the risks of inconsistencies and damage potential of manual egg manipulation and sperm injection, helping improve success rates and accessibility for couples, profitability for clinics and cost-effectiveness for NHS Clinical Commissioning Groups(CCGs).


Research activity codes: 5.3 MEDICAL DEVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: An innovative medical device that uses neuromodulatory technology to address menstrual health symptoms and increase the productivity of women
Funder: Innovate UK

Abstract: Samphire is a UK medical device SME with a core project team of Emile Radyte (CEO/project lead), Alexander Cook (COO/commercial lead) and Ervinas Bernatavicius (product manager/technical lead). A large majority of reproductive-age women experience menstruation-related symptoms and have missed work as a result, which has led to a loss of productivity through sickness, absence and underperformance by those women who go to work while feeling unwell. The annual cost of this productivity loss in the UK has been estimated at £17.4B. Current options for dealing with menstrual symptoms are limited, with a large emphasis on pharmacological solutions. This leaves women with few options to manage their symptoms. Samphire is developing a wearable, non-invasive medical device in the form of a hairband that uses personalised neuromodulatory technology to address mood and pain-related menstrual health symptoms. The device is being built alongside women and uniquely adapted for their needs. The SamphireNeuro Device will be a personalised, effective and innovative solution for pre-menstrual depression and menstrual pain experienced by four in five women. It will improve women's productivity, in some cases by over 23 days per year, positively impacting their wellbeing, work opportunities and equality. The device, which is being built on trusted and valid science, contains three key innovations that make it the first solution of its kind for an unaddressed need.


Research activity codes: 5.3 MEDICAL DEVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: Feasibility study for detection of PCOS in novel sample
Funder: Innovate UK

Abstract: Syrona is an online digital clinic for women's health providing screening and support service with an app to monitor symptoms and book gynaecologist consultations online. 1 in 5 women in the UK suffers from PCOS. There is an increase in misdiagnosis and long waiting times with women often having to visit the GP 3 times on average before testing begins. Therefore a home-test based screening service would achieve higher uptake due to convenience, simplicity, privacy and a non-invasive sample collection method. The feasibility studies will include both clinical and non-clinical work packages. The clinical work package will demonstrate biomarker performance against the gold standard and the non-clinical work package will help software development to support online gynaecologist consultations and patient symptom monitoring. We envision the commercialisation of this innovation in the format of a home-kit (sample collected at-home) which will act as a screening tool for women who are at risk of having PCOS. All results will be in the format of a risk analysis which combines both the biological (lab results) and digital patient-recorded symptom data sets (App). Further diagnosis such as scans (TVUS) will then be conducted by a registered physician. Our future ambitions will see our platform expanded to secondary markets beyond the UK and sustainable financing of future innovations in other women's health conditions such as endometriosis for instance.


Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: A 3Rs approach to investigate the feto-maternal interface: visualisation of pathogen and antibody in a 3D in vitro human placental model.
Funder: National Centre for the Replacement, Refinement and Reduction of Animals in Research

Abstract: Background. Immunisation during pregnancy is now recognised as an efficient approach to protect the fetus and/or the infant from life-threatening infection. However, the mechanisms underlying the transmission of


Research activity codes: 2.1 BIOLOGICAL AND ENDOGENOUS FACTORS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: The IVF Histories and Cultures Project
Funder: The British Academy

Abstract: Since 2005, the IVF Histories and Cultures Project (IVFHCP) has brought together a wide range of collaborators to research, uncover and preserve the unique history of IVF in the UK. This history, which emerges out of the postwar expansion of the life sciences, and is propelled by discoveries in agriculture and animal breeding as well as in human reproductive and developmental biology, is arguably one of the most influential technological chapters in the modern industrial era and yet remains surprisingly understudied. Although the Human Genome Project is the poster child of the life sciences in the late twentieth century, it is in fact the study of reproduction and embryology that yield far greater and more consequential clinical applications between 1950 and the present day. Cambridge is now unquestionably the home of the most important research on IVF histories and cultures and how they are continuing to reshape our world today.


Research activity codes: 8.5 RESOURCES AND INFRASTRUCTURE (HEALTH SERVICES)
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH