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P. Aschnu, M.A., M.D., M.P.H.

Program Director, Geisinger Commonwealth School of Medicine

Metformin therapy throughout pregnancy reduces the development of gestational diabetes in women with polycystic ovary syndrome. Follitropin-alpha versus human menopausal gonadotropin in an in vitro fertilization program. Multiple gestations in assisted reproductive technology: can they be avoided with blastocyst transfers? Effectiveness of two-step (consecutive) embryo transfer in patients who have two embryos on day 2: comparison with cleavagestage embryo transfer. Further considerations on natural or mild hyperstimulation cycles for intrauterine insemination treatment: effects on pregnancy and multiple pregnancy rates. A comparison of luteal phase support in graduated estradiol/progesterone replacement cycles using intramuscular progesterone alone versus combination with vaginal suppositories on outcome following frozen embryo transfer. Correctly timed coasting reduces the risk of ovarian hyperstimulation syndrome and gives good cycle outcome in an in vitro fertilization program. Overnight incubation improves selection of frozen-thawed blastocysts for transfer: preliminary study using supernumerary embryos. A meta-analysis and comparison with the Society for Assisted Reproductive Technology database. Selection of embryos for day-3 transfer at the pronuclear-stage and pronuclear-stage cryopreservation results in high delivery rates in fresh and frozen cycles. Practitioner reporting of birth defects in children born following assisted reproductive technology: Does it still have a role in surveillance of birth defects? Recombinant follicle stimulating hormone in in-vitro fertilization treatment-clinical experience with follitropin alpha and follitropin beta. Effect of aspiration vacuum on the developmental competence of immature human oocytes retrieved using a 20-gauge needle. Severe hypospermatogenesis in cases of nonobstructive azoospermia: should we use fresh or frozen testicular spermatozoa? Effects of letrozole on superovulation with gonadotropins in women undergoing intrauterine insemination. Defining women who are prone to have twins in in vitro fertilization-a necessary step towards single embryo transfer. Full Text: Exclude Q4-Outcomes not correlated with history or infertility or treatment. Perinatal outcome of singletons and twins after assisted conception: a systematic review of controlled studies. Spontaneous conception after a successful attempt at in vitro fertilization/intracytoplasmic sperm injection. Patient attitudes towards twin pregnancies and single embryo transfer - a questionnaire study. Prospective study of parental choice for aneuploidy screening in assisted conception versus spontaneously conceived twins. Laser-assisted hatching of embryos is better than the chemical method for enhancing the pregnancy rate in women with advanced age. Clinical implications of intracytoplasmic sperm injection using cryopreserved testicular spermatozoa from men with azoospermia. Maternal serum pregnancy-associated plasma protein-A and free betahuman chorionic gonadotrophin in pregnancies conceived with fresh and frozen-thawed embryos from in vitro fertilization and intracytoplasmic sperm injection. Epidemiology of infertility and polycystic ovarian disease: endocrinological and demographic studies. Hydrosalpinx treated with extended doxycycline does not compromise the success of in vitro fertilization. A minimally monitored assisted reproduction stimulation protocol reduces cost without compromising success. Ultra-short metformin pretreatment for clomiphene citrate-resistant polycystic ovary syndrome. Combined approach as an effective method in the prevention of severe ovarian hyperstimulation syndrome.

As required by the Debt Collections Improvement Act of 1996, all Federal payments to award recipients pursuant to this announcement will be made by electronic funds transfer. Public reporting for this collection of information is estimated to be three hours per response, including the time for reviewing instructions, and completing and reviewing the collection of information. All responses to this collection of information are voluntary, and will be protected from disclosure to the extent allowed under the Freedom of Information Act. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Reports Clearance Officer, International Trade Administration, Department of Commerce, Room 4001, 14th and Constitution Ave. The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Pub. The survey will be conducted in two parts to differentiate between resource management needs and information management needs. Both sections will be sent to the coastal manager, who would be asked to forward the second section to the data/information manager. The survey is targeted for release to the coastal community in February 1999, and results will be compiled during the summer months of that year. Method of Collection the survey will be mailed to clients with an option to respond electronically or by mail. Affected Public: Not-for-profit institutions; state, local, or tribal government (coastal managers from the following programs or agencies: Coastal Zone Management Programs, National Estuarine Research Reserve Sites, National Marine Sanctuaries, Sea Grant Institutions, Natural Resource Management Agencies, and National Estuary Programs. The overall objectives of the survey are: to receive feedback from the coastal management community on the relevance, importance, and need of specific proposed products; to give coastal resource managers the opportunity to describe their priority problems and management needs; and to obtain information on the hardware and software platforms and capabilities of the coastal information management 59942 Federal Register / Vol. The 1999 limits for certain categories have been reduced for carryforward applied to the 1998 limits. Michael Hutchinson, Acting Chairman, Committee for the Implementation of Textile Agreements. Dear Commissioner: Pursuant to Section 204 of the Agricultural Act of 1956, as amended (7 U. Linda Engelmeier, Departmental Forms Clearance Officer, Office of the Chief Information Officer. Products in the above categories exported during 1998 shall be charged to the applicable category limits for that year (see directive dated November 19, 1997) to the extent of any unfilled balances. Twelve-month limit 2,738,549 square meters of which not more than 850,058 square meters shall be in Category 410. The Committee for the Implementation of Textile Agreements has determined that these actions fall within the foreign affairs exception of the rulemaking provisions of 5 U. Michael Hutchinson Acting Chairman, Committee for the Implementation of Textile Agreements. Products in the above categories exported during 1998 shall be charged to the applicable category limits for that year (see directive dated November 24, 1997) to the extent of any unfilled balances. In carrying out the above directions, the Commissioner of Customs should construe entry into the United States for consumption to include entry for consumption into the Commonwealth of Puerto Rico. The Committee for the Implementation of Textile Agreements has determined that these actions fall within the foreign affairs exception to the rulemaking provisions of 5 U. Products in the above categories exported during 1998 shall be charged to the applicable category limits for that year (see directive dated December 9, 1997) to the extent of any unfilled balances. In the event the limits established for that period have been exhausted by previous entries, such products shall be charged to the limits set forth in this directive. Michael Hutchinson, Chairman, Committee for the Implementation of Textile Agreements. The 1999 limit for Categories 347/348 is being decreased for carryforward applied to the 1998 limit. Products in the above categories exported during 1998 shall be charged to the applicable category limits for that year (see the December 22, 1997 directive) to the extent of any unfilled balances. Twelve-month restraint limit Category 625/626/627/628/629 Twelve-month restraint limit 83,859,305 square meters of which not more than 41,929,654 square meters shall be in Category 625; not more than 41,929,654 square meters shall be in Category 626; not more than 41,929,654 square meters shall be in Category 627; not more than 8,675,101 square meters shall be in Category 628; and not more than 41,929,654 square meters shall be in Category 629. For quota purposes only, products remaining in categories partially integrated will continue to be designated by the designator ``pt. Products in the above categories exported during 1998 shall be charged to the applicable category limits for that year (see directive dated November 25, 1997) to the extent of any unfilled balances. The import restraint limits for textile products, produced or manufactured in Qatar and exported during the period January 1, 1999 through December 31, 1999 are based on limits notified to the Textiles Monitoring Body pursuant to 59948 Federal Register / Vol. The 1999 limit for Categories 347/348 has been reduced for carryforward applied to the 1998 limit.

Variability in outcome measures makes between-study comparisons difficult regarding specific techniques. Techniques involving some form of sedation result in 138 lower intraoperative pain, but this does not appear to adversely affect overall patient perceptions and satisfaction. There is insufficient evidence to determine the optimal method for endometrial preparation for frozenthawed embryo transfer. Pre-transfer irrigation does not improve pregnancy or live birth rate and, based on an intent-to-treat analysis of the one study identified, significantly reduces both rates. Although pretreatment with antibiotics significantly lowers measurable bacterial contamination, this does not translate into improved pregnancy or live birth rates. The consistency of this finding and the size of the effect are striking considering that the majority of interventions evaluated in this review do not show significant differences. Although there is no detectable difference between oral progesterone and the various formulations of vaginal progesterone, both result in lower pregnancy and live birth rates compared to intramuscular progesterone. Randomized trials of intercessory prayer and acupuncture showed benefit, but there are remaining methodological questions which need to be addressed. Other surgical interventions shown to improve outcomes are hysteroscopic removal of endometrial lesions and surgical removal or occlusion of hydrosalpinges. Technical aspects of the fertilization procedure, such as media and equipment used, may have significant impact on outcomes. There is insufficient evidence to draw any inferences regarding the effect of culture media on pregnancy or live birth C. The addition of a zygote cleavage score to embryo quality scoring based on morphology did not result in improved pregnancy or live birth rates. Preimplantation genetic screening resulted in lower overall pregnancy and live birth rates in women 37 and older. The available evidence suggests that zygote transfer is, at best, no better than day 3 transfer and may result in worse pregnancy and live birth rates. The disadvantage of delaying transfer is a reduction in the number of embryos available for transfer and for cryopreservation, and the increased risk of monozygotic twinning. General Issues Our review of the current evidence on fetal and maternal outcome raises several important issues which need to be considered in interpreting the existing literature, and in planning future research. First, although we found several consistent associations that should be considered by patients, clinicians, and policymakers in making decisions about various aspects of infertility, it is important to remember that the overwhelming majority of the literature consists of observational studies. The most common design was a modified cohort study, where all of the women exposed to a particular treatment were compared to a sample, either random or matched for known confounders, and the incidence of the outcomes compared. We also identified several population-based cohort studies, where all infertility patients were compared to all other pregnant women and their infants in a given geographic area. Case-control studies, in which all of the subjects with a given outcome are selected along with a matched or unmatched sample of subjects without the outcome, were much less common, and were, appropriately, primarily used for less common outcomes, such as cancer and specific congenital abnormalities. Although 140 these study designs are valid and well-established tools for epidemiologic research, it is important to remember the strong potential for unmeasured confounding, especially when examining the association between a clinical treatment and the outcomes of interest. All of the reasons for using caution when interpreting the results of observational studies reporting clinical benefits apply to observational studies of adverse outcomes. Ideally, data from randomized trials would be used, but, given the relative rarity of many important outcomes relative to the number of women treated or number of children, and the consistently small sample size chosen for most randomized trials in this field, pooling of data is likely to be required. For many of the outcomes discussed under this Question, any association between a specific treatment and that outcome could be either a true causal association, or an association between the underlying reason for the treatment and the subsequent outcome. In many cases, associations that were significant when infertility patients were compared to the general population weakened quantitatively when other infertility patients, or women with a prolonged time to conception, were used as controls. Although identifying such women may be difficult in many situations, failure to consider the appropriateness of the control group could easily lead to misinterpretation of study results. This is certainly true of outcomes likely to occur 10 or more years after treatment, such as cancers, but may well be true of shorter time intervals as well. Changes in indications, in the types of patients considered appropriate or inappropriate for a given treatment, and changes in aspects of the treatment itself that might affect these outcomes can render results irrelevant for current patients. For outcomes such as cancer, information can still be helpful if it helps target preventive efforts; however, for many shorter-term outcomes, particular those related to pregnancy and early childhood, even very strong and consistent associations may be due to factors which are no longer present. The extent to which differences among infertility patients in factors such as race/ethnicity, socioeconomic status, and education affect observed associations is unclear. With these caveats, we will summarize the results of the review for this Question.

Effectiveness of psychosocial group intervention for reducing anxiety in women undergoing in vitro fertilization: a randomized controlled study. A comparison of the outcomes between twin and reduced twin pregnancies produced through assisted reproduction. Use of gonadotropinreleasing hormone antagonists to overcome the drawbacks of intrauterine insemination on weekends. Comparison of pronuclear zygote morphology and early cleavage status of zygotes as additional criteria in the selection of day 3 embryos: a randomized study. A comparative randomized multicentric study comparing the step-up versus step-down protocol in polycystic ovary syndrome. Factors influencing adverse perinatal outcomes in pregnancies achieved through use of in vitro fertilization. A comparison of heterotopic and intrauterine-only pregnancy outcomes after assisted reproductive technologies in the United States from 1999 to 2002. Embryo transfer under ultrasound guidance improves pregnancy rates after in-vitro fertilization. Endometrial preparation for frozen-thawed embryo transfer with or without pretreatment with gonadotropin-releasing hormone agonist. Half-dose depot triptorelin in pituitary suppression for multiple ovarian stimulation in assisted reproduction technology: a randomized study. Analysis of 104 twin pregnancies conceived with assisted reproductive technologies and 193 spontaneously conceived twin pregnancies. Are cause of subfertility and in vitro fertilization treatment risk factors for an earlier start of menopause? Singleton pregnancies are as affected by ovarian hyperstimulation syndrome as twin pregnancies. Birthweight of singletons after assisted reproduction is higher after singlethan after double-embryo transfer. High frequency of iatrogenic monozygotic twins with administration of clomiphene citrate and a change in chorionicity. Highly purified human-derived follicle-stimulating hormone (Bravelle) has equivalent efficacy to follitropin-beta (Follistim) in infertile women undergoing in vitro fertilization. Effect of acupuncture on the outcome of in vitro fertilization and intracytoplasmic sperm injection: a randomized, prospective, controlled clinical study. Obstetric outcomes after in vitro fertilization in obese and morbidly obese women. Effects of gonadotrophinreleasing hormone agonists on human ovarian steroid secretion in vivo and in vitro-results of a prospective, randomized in-vitro fertilization study. Comparison of two different starting multiple dose gonadotropin-releasing hormone antagonist protocols in a selected group of in vitro fertilization-embryo transfer patients. European and Israeli Study Group on Highly Purified Menotropin versus Recombinant Follicle-Stimulating Hormone. Efficacy and safety of highly purified menotropin versus recombinant follicle-stimulating hormone in in vitro fertilization/intracytoplasmic sperm injection cycles: a randomized, comparative trial. Human recombinant luteinizing hormone is as effective as, but safer than, urinary human chorionic gonadotropin in inducing final follicular maturation and ovulation in in vitro fertilization procedures: results of a multicenter doubleblind study. Effects of recombinant human luteinizing hormone supplementation on ovarian stimulation and the implantation rate in downregulated women of advanced reproductive age. Catheter type does not affect the outcome of intrauterine insemination treatment: a prospective randomized study. Comparison of controlled ovarian stimulation with human menopausal gonadotropin or recombinant follicle-stimulating hormone. Ovarian function and metabolic factors in women with oligomenorrhea treated with metformin in a randomized 178 double blind placebo-controlled trial. A randomized double-blind controlled study on the efficacy of laser zona pellucida thinning on live birth rates in cases of advanced female age. Sequential treatment of metformin and clomiphene citrate in clomipheneresistant women with polycystic ovary syndrome: a randomized, controlled trial. Use of ethinyl estradiol to reverse the antiestrogenic effects of clomiphene citrate in patients undergoing intrauterine insemination: a comparative, randomized study. Effect of rosiglitazone on spontaneous and clomiphene citrateinduced ovulation in women with polycystic ovary syndrome. Intravenous albumin versus hydroxyethyl starch for the prevention of ovarian hyperstimulation in an in-vitro fertilization programme: a prospective randomized placebo controlled study.