Reproductive immunology is relatively new and young branch of reproductive medicine. Miscarriage or abortion whether recurrent or not is a common and distressing complication of pregnancy. It was estimated that a small percentage of global population experience recurrent pregnancy loss or abortion. Various immunotherapy medications tested so far through high quality trials have been shown to offer no benefit in the area of recurrent abortion. Majority of the women diagnosed with recurrent abortion or miscarriages are in vulnerable state. Clinical trials provide immune modulatory treatment for recurrent abortions and patients are counselled about success rates and potential risk/benefits along with routine clinical practices.
Even after diagnosis of recurrent abortion, majority of pregnancies are estimated to have a favourable outcome. However, women are investigated and managed in a specialist miscarriage clinic for counselling, support, evidence-based investigation, and an opportunity to take part in research. Healthy diet and management of modifiable risk factors are of major help within the clinical trials. The immune response to pregnancy or uterus rejecting the embryo or foetus is said to explain a large number of otherwise unexplained abortions or miscarriages. Preventive treatments are designed to suppress the immunological rejection during embryo implantation and help in preventing recurrent pregnancy loss. A wide range of immunomodulatory treatments are offered, most of which are non-evidence based. The latest treatment is a drug known as recombinant human granulocyte-colony stimulating factor (rhG-CSF), a regulator of neutrophils and other lymphocytes activating and protecting the immune system.
According to the study “Recurrent Abortion Global Clinical Trials Review, H1, 2018”, the leading competitors within the global recurrent abortion clinical trials are Besins Healthcare SA, Pfizer Inc, Novozymes GroPep, Fonds NutsOhra and Abbott Laboratories. Geographically, the global recurrent abortion clinical trials are spread across all the countries around the world.
It was observed that no evidence has proved rhG-CSF given in the first trimester of pregnancy improves outcomes in women with a history of unexplained recurrent pregnancy losses. However, use of rhG-CSF has suggested a statistically significant increase in pregnancy and live birth rates in the clinical trials. Globally, granulocyte-colony stimulating factor is widely used in reproductive medicine to treat natural pregnancies and after assisted pregnancies following recurrent abortions. Clinical trials with an endpoint defined recurrent abortions or miscarriage as undefined and unexplained, thereby, suggesting neutral effect of various treatments carried out in clinical trials. Increasing incidences of unexplained abortions across the globe, innovative treatments, fast regulatory approval process, and increasing clinical trials for recurrent abortions are the key factors that will drive global clinical trials in recurrent abortions over the next few years.
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Ankur Gupta, Head Marketing & Communications