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The equipment, the personnel and the space requirements needed to perform intrauterine insemination (IUI) and ovulation induction (OI) will depend on the number and type of procedures to be performed, and on the availability of other infertility services in the area. A gynecology or general practice office or clinic that routinely performs speculum examinations and only intends to perform IUI with cryopreserved donor sperm will already have all the necessary equipment if it has a microscope and either performs ultrasound or has it available nearby. Larger offices and clinics that plan to offer IUI with husband's or partner's sperm will need appropriate counter space for equipment to perform semen analysis, sperm processing and other tests if required. If they also plan to cryopreserve sperm, they will need additional space for liquid nitrogen tanks and storage space for Dewar cryogenic storage tanks. Clinics that monitor their own reproductive hormone levels during the cycles require additional equipment and a substantial increase in counter and laboratory space.
This chapter describes the requirements for clinic layout and personnel in general terms, and provides lists of equipment, disposable supplies and safety items that may be needed, depending on the specific procedures that an infertility office or clinic plans to perform.
Clinics that perform therapeutic fertility treatments should be designed in such a way that they are capable of providing the best patient care (Fig. 4.1). Small private clinics as well as large clinics need sufficient lobby space and a friendly, welcoming atmosphere.
Insemination technique has changed greatly during the past 40 years, from a simple vaginal technique that was little different than that used by John Hunter in 1785 to intracervical (ICI), intrauterine (IUI), fallopian tube sperm perfusion (FSP) and direct intraperitoneal insemination (DIPI) techniques. When Nachtigall et al. reviewed the status of artificial insemination in 1979, nearly all inseminations were vaginal and pregnancy rates were generally satisfactory when donor sperm was used or insemination with partner sperm was performed because of physical problems, but very poor when insemination with partner sperm was performed because of low sperm count. The semen specimen was usually fresh for both donor and partner insemination, except in rare cases where multiple samples of poor-quality sperm were cryopreserved in the hope that sufficient “good” sperm would be available when the accumulated specimens were thawed. Those cases were nearly always unsuccessful.
Successful pregnancies following intrauterine insemination of 10 minims (0.6 mL) of fresh unprocessed sperm were reported in 1920, but the procedure was abandoned because of concern about infection. Furthermore, the amount inseminated had to be kept small to reduce uterine cramping, so it was not helpful in cases where the sperm count was low. When insemination techniques were compared in 1957, pregnancy rates for IUI were worse than when the entire sperm specimen was placed in a cervical cup applied to the cervix, or simply deposited in the vagina.
In the present day, insemination with both donor and partner semen is nearly always performed by the intrauterine insemination (IUI) technique.
Intrauterine insemination and ovulation induction is effective first-line treatment for infertility in many straightforward cases and is preferred by many clinicians because they are less invasive than in-vitro fertilization and its variants. This is a comprehensive account of how to set up and run a successful IUI program. The book addresses the practical aspects of treatments that will produce optimum results in terms of pregnancy outcome and safety, as well as the pharmacological and physiological reasons for their use. Chapters on how to prevent complications of ovulation induction such as multiple births and ovarian hyperstimulation syndrome are included, as well as how to diagnose infertility in both sexes. Laboratory procedures for sperm preparation are described in detail. Worldwide resources for obtaining donor sperm and legal issues that surround the management of patients are included. This manual is of interest to reproductive medicine specialists, general practitioners and general obstetrician gynecologists.
The semen analysis (SA) in the form in which it appears today is a relatively recent invention. The definition of a “normal” semen analysis was not standardized until publication of the World Health Organization (WHO) Laboratory Manual for the Examination of Human Semen and Sperm–Cervical Mucus Interactions in 1980. Between 1869, when Sims reported that sperm needed to be present in cervical mucus for conception to occur, and 1951, the Sims–Huhner postcoital test and the presence of motile sperm on a microscopic slide were considered the only tests necessary to evaluate male fertility. The postcoital test was used as part of their initial evaluation of infertile couples by 92% of infertility specialists in private practice in the United States according to a survey taken in 1998. Examination of a droplet of ejaculate under the microscope remains a highly accurate, easy-to-perform “qualitative” test of male fertility.
In 1951, MacLeod and Gold analyzed the sperm counts of 1,000 fertile and 1,000 infertile men stratified at intervals of 20 × 106/mL. They observed that 19% of infertile men had counts of less than 20 × 106/mL, compared to 8% of fertile men. On this basis they stated that men with sperm counts above 20 × 106/mL were fertile, and men with counts below that concentration were subfertile, even though they had not further stratified counts of less than 20 × 106.
Donor insemination is the only insemination procedure performed by many physicians. It is convenient, easy to perform and requires no special equipment. Unwashed donor sperm can be purchased from commercial sperm banks “ready to use.” Commercial sperm banks usually provide specimens in screw-topped polypropylene cryovials containing 10–30 × 106 motile sperm after thaw in 1 mL media. Specimens may be either prewashed for intrauterine insemination (IUI) or unwashed for vaginal (IVI) or intracervical insemination (ICI). Unwashed specimens can also be used for IUI after they are washed by the recipient clinic. Specimens may also be provided in straws in 0.5 mL of media.
Unwashed specimens need only to be thawed at room temperature or in warm water for 5–10 minutes to be ready for IVI and ICI. IUI specimens require centrifugation to remove the cryoprotectant, even if they were prewashed. Because liquid nitrogen (LN2) is extremely hazardous if spilled, specimens are usually “dry” shipped in smaller versions of the Dewar LN2 tanks used for long-term storage (Fig. 12.1). Dry-shipping tanks contain small amounts of LN2 at the bottom sufficient to maintain the temperature of vials or straws suspended in LN2 vapor at −180°C for 10–12 days from the date the shipper was filled. Sperm specimens that can not be used within this time may be transferred to regular larger LN2 tanks for long-term storage. A few commercial banks still ship donor sperm in dry ice overnight for use the next day.
The clinical use of frozen-stored human semen or sperm is practical, beneficial, safe and it provides a readily available method for the treatment of infertility and the preservation of fertility. It was known in the eighteenth century that sperm could survive freezing. However, the first published report of successful insemination of cryopreserved sperm did not appear until 1954. Since then, improvements in cryoprotectant media and freezing protocols have made sperm cryopreservation applicable for all aspects of therapeutic insemination. When human chorionic gonadotropin (hCG) injection or luteinizing hormone (LH) timing and equal numbers of progressively motile donor sperm are used for intrauterine insemination, there is no difference in pregnancy rates between fresh and cryopreserved sperm. Most clinical practices that perform large numbers of inseminations with fresh sperm will wish to be able to cryopreserve patient sperm. If a clinical practice does not itself perform cryopreservation it may still refer patients to clinics or laboratories that do, and arrange for the cryopreserved specimen to be returned to the practice for thaw and insemination, as would be done in a case of donor insemination.
The advantages of frozen sperm over fresh sperm are many (Table 11.1). Cryopreservation provides the means to disassociate sperm collection and processing from ovulation. It is always available for use. For men with low total sperm counts several ejaculates can be frozen and combined later. Conversely, for men with high total sperm counts a single ejaculate can be used in several insemination cycles if they are not always available to furnish a fresh specimen.
Th is manual is intended for the general or family practitioner, as well as for gynecologists and specialists in infertility treatment. While treatment by in-vitro fertilization (IVF) and other advanced techniques attract the most attention and shape the public perception of infertility treatment, far more infertile couples achieve pregnancies with ovulation induction (OI) or combined ovarian stimulation and intrauterine insemination (IUI), the two techniques described in detail in this book, and which form the first line of infertility treatment. Moreover, they can be performed in almost any office or clinic, thus allowing patients to be treated by physicians and nurses already familiar with their general health, without the need to travel to distant specialty clinics. Many practitioners believe, from their time in training, that evaluation of infertile couples is too time-consuming and unrewarding, and that treatment is too complex to be part of their general or obstetric and gynecological practices. Nothing could be further from the truth. Infertility should be viewed, not as a diagnosis, but as a symptom of an underlying medical problem, affecting either one or both partners, which, if left untreated, will eventually affect their general health and emotional well-being.
The objective of sperm preparation for intrauterine insemination (IUI) is to separate seminal fluid containing prostaglandins from sperm by centrifugation so that the latter can be introduced into the uterus without causing severe cramping. If semen is mixed with a buffered solution supplemented with human serum albumin (HSA) before centrifuging, constituents that stabilize the sperm membrane and prevent capacitation are removed. Advanced preparation procedures described in this chapter select out motile and superior-quality sperm by removing dead and abnormal sperm, immature sperm cells, white cells and debris – thus mimicking the in-vivo process of selecting motile sperm as they progress through the female reproductive tract, while leaving behind dead and immotile sperm and debris. Dead, immotile and abnormal sperm produce 10–15 times more reactive oxygen species (ROS) than motile sperm. High levels of ROS reduce fertilization potential.
Many methods have been described in the past for preparation of sperm for IUI. The three principal methods in use today are:
Standard sperm wash (SSW) – which removes seminal plasma from the semen specimen by centrifugation.
Swim-up (SWU) – which uses self-migration of motile sperm from the bottom fraction to the top fraction, followed by centrifugation to remove dead and immotile sperm and debris.
Density gradient centrifugation (DGC) – which separates motile sperm by density, using repeated centrifugation of semen mixed with a media containing a colloidal suspension of silica products. Motile sperm have higher density than non-motile and dead sperm.
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