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			Concern Treatment Pregnancy Experiences Treatment The Doctor's Visit Personalised Treatment What is Recombinant? What is Filled By Mass? Female Treatments Male Treatments Implications of Treatment Enhance Your Well-being Questions to Ask Your Doctor Treatment FAQ Devices for Administration of Medication		What is Recombinant? Developed in the early 1980s, Recombinant Technology is a process for the production of hormones using deoxyribonucleic acid (DNA). Prior to its discovery, hormones were only extracted and purified from the urine of post-menopausal women. This is still a valid and effective method of reproductive hormone production today, and many thousands of couples experience success with treatment using this style of hormone. The development of Recombinant Technologies to produce hormones, however, is assisting in the two areas of fertility treatment that are key to improving ovarian stimulation and a person's chance of becoming pregnant: Effective fertility drugs for precise control over ovarian stimulation The ability to tailor treatment to meet individual patients needs          How does it work? Each cell of a living organism (whether bacteria or human being) contains one or more molecules of DNA that can be compared to a 'library' of genetic information. This library contains all the 'books' (the genes) necessary for the production of a variety of molecules (proteins) essential for life. The coding system for production of these molecules is universal. However, each cell in each organism is programmed to produce only a limited number of specific proteins within a specific environment. It was discovered that genes could be transferred from one cell to another. This meant that a cell could be re-programmed to secrete a particular protein, for example growth hormone, by introducing the gene coding for growth hormone, although it had not initially been programmed to do so (see diagram 1 below). These modified cells - now called recombinant cells - transmit new characteristics to their descendants. When put into cell culture, the cell multiplies itself and the colony of daughter cells that arises secretes the desired protein. Transferring a gene from one cell to another This new technique has opened the door to an array of applications in the medical field. It became possible to produce much purer molecules than before, in guaranteed quantities, without relying on raw materials such as urine.  The manufacturing process is consistent and easier to control than extraction and purification processes, but requires massive investments in sophisticated technology to achieve it. Research on the production of gonadotropins (fertility hormones) by recombinant DNA technology began in the mid-1980s. Bacterial cells such as Escherichia coli (E. coli) were thought to be the ultimate production system for recombinant protein drugs. However, this was only true for small, simple proteins, not the larger, more complex therapeutic proteins such as human follicle stimulating hormone (h-FSH), human luteinising hormone (h-LH) and human chorionic gonadotropin (hCG).  Timeline: Advances in Hormone Production Mammalian cells were found to be suitable host cells to produce biologically active gonadotropins. Serono therefore proceeded down the route of mammalian cell technology to achieve its aim of producing recombinant gonadotropins for use in the treatment of infertility.  Recombinant in infertility treatment  A number of key hormones used in the treatment of infertility are produced using Recombinant Technology. These include: Recombinant human follicle stimulating hormone (r-hFSH): This is used in ovulation induction (OI) and in controlled ovarian stimulation programs in assisted reproductive technologies (ART). Recombinant luteinizing hormone (r-hLH): Most women undergoing ART usually only require FSH to prompt multiple follicular development. However, LH is also a key hormone during this process. Recombinant human chorionic gonadotropin (r-hCG): This is used after ovarian stimulation to trigger ovulation in women with infertility due to impaired ovulatory function, and to promote final follicular maturation in women undergoing ART. Benefits of Recombinant For over forty years, urinary derived gonadotropins have helped hundreds of thousands of infertile couples to fulfil their dream of having a child. The use of recombinant DNA technology will continue to make dreams come true in a safer and more efficacious way thanks to the quality of this new generation of products. The remarkable range of benefits include: For over forty years, urinary derived gonadotropins have helped hundreds of thousands of infertile couples to fulfil their dream of having a child. The use of recombinant DNA technology will continue to make dreams come true in a safer and more efficacious way thanks to the quality of this new generation of products. The remarkable range of benefits include: Purity and tolerability Until the early 1990s, purification techniques used to produce gonadotropin (hormones important to reproduction) preparations yielded products with less than 5% of active ingredient and more than 95% of extraneous proteins. Advances in purification techniques made high purity products available in 1993, with some containing more than 95% of pure hormone. However, using recombinant DNA technology, the non FSH-derived protein content has been brought down to <1%. Due to their purity, recombinant therapies are less likely to cause local and systemic allergic reactions such as skin redness and irritation. Availability and consistency Before the introduction of recombinant gonadotropins, FSH, LH and hCG had been extracted from the urine of post-menopausal women, a process requiring daily collection of urine from donors. The laborious and complicated collection process had significant drawbacks, including limitations on volume and suboptimal purity of the final products. Recombinant DNA technology allows total control of the production process, thus eliminating problems of availability and variability associated with the production of urinary derived gonadotropins. Increased patient comfort and convenience The extremely high purity of recombinant gonadotropin preparations makes them suitable for subcutaneous injection. Most other gonadotropins require intramuscular administration. The subcutaneous route has distinct benefits for patients, as self administration becomes an option. Increased efficacy It has recently been suggested that r-hFSH is preferred over u-hFSH for ovarian stimulation in patients undergoing ART. A systematic review of randomised controlled trials (meta-analysis) published by Daya is the first to date to conclude that r-hFSH is significantly more effective than u-hFSH, with respect to clinical pregnancy rates. Those women receiving r-hFSH were 20% more likely to achieve clinical pregnancy than those given u-hFSH, following ovarian stimulation for either in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). More specifically, those IVF patients treated with r-hFSH were 26% more likely to achieve clinical pregnancy than those treated with u-hFSH. In that same sub-group, patients treated with GONAL-f™ were 36% more likely to achieve a clinical pregnancy than those treated with another r-hFSH. Safety As with all medicines, undesirable effects may occasionally occur with the use of fertility drugs. The most common side effects are injection site reactions, headache, nausea, vomiting, breast tenderness, abdominal discomfort and ovarian cysts. It is well known that headache, nausea and vomiting are associated with changes in circulating oestrogen levels.
			© 2003-2008 Merck Serono S.A. Please read our Legal Statement. US residents should consult the Serono, Inc. fertility website at www.fertilitylifelines.com Last Updated: 5/6/2008