July 5, 2009 A major new trial recently published in the journal Fertility and Sterility shows that for couples beginning infertility treatments, an accelerated path to in-vitro fertilization (IVF) can offer a shorter time to pregnancy, cost savings of nearly $10,000, and a lowered risk of multiple births.
For the first time, these results demonstrate that the long held treatment combining fertility injections with insemination (IUI) does not have a place in infertility treatments today. This study also demonstrates that today’s infertility treatments are very successful. When fertility care is covered by insurance (or alternatively when couples can afford all needed treatment), the vast majority will have a baby, and the quickest way to get pregnant is to follow this new shortened protocol.
Elizabeth Ginsburg, President of the Society for Assisted Reproductive Technology, commented, "This is a very important study that will likely influence physicians to reduce the number of stimulated inseminations for patients with unexplained infertility. Adoption of such an accelerated course of treatment could result in many patients conceiving in less time with less expense."
Known as the FASTT (fast-track and standard treatment) Trial, this study is the largest of its kind to date to measure the effectiveness of contemporary infertility treatments. Led by Richard Reindollar, M.D., Chair of the Department of Obstetrics and Gynecology at Dartmouth-Hitchcock Medical Center and Dartmouth Medical School, the study omitted the gonadotropin-stimulated artificial insemination cycle that usually precedes assisted reproductive technology, for approximately one-half of the 503 participating couples.
“One key strength of the trial was the Massachusetts Infertility Mandate, which requires insurers to cover the cost of fertility treatments,” said Dr. Reindollar. “Such a large trial would not have been possible in a self-pay or partial coverage environment in which the cost of care is a much larger factor in the couple’s choice of therapy.”
Reindollar says another strength of the study in relation to previous efforts on the subject was a large volume of patients available at a single IVF center which allowed for standardized protocols and procedures. In addition, since the study was done in cooperation with insurance companies, there was access to detailed charge data for the patients.
Couples with unexplained infertility seeking treatment at Boston IVF or Harvard Vanguard Medical Associates were screened for eligibility to participate in the randomized, controlled trial. Eligibility criteria included: trying to conceive for 12 months without prior fertility treatment (excepting up to three cycles of clomiphene without intrauterine insemination (IUI)); a female partner 21 to 39 years old with sufficient ovarian reserve and without pelvic pathology; and adequate sperm concentration in the male partner.
Couples enrolled in the study followed either a conventional course of treatment or an accelerated course until they achieved pregnancy or elected to stop treatment. The conventional treatment included three cycles of the fertility pills with inseminations (IUI), followed by three cycles of the fertility injections with inseminations, then up to six cycles of IVF. The accelerated treatment plan omitted the cycles with fertility injections and IUI and went to IVF after three cycles of the fertility pill combined with IUI. The couples were followed from the date of their enrollment until the closing date of the study. Charge data obtained from insurers included all health care items and services for women during the trial.
Of 503 couples enrolled, 64% delivered at least one baby by the end of the study and an additional 10% had an ongoing pregnancy beyond 5 months. Babies were born to 150/247 couples in the conventional treatment group and to 171/256 couples in accelerated treatment. The time to pregnancy was significantly shortened for the couples in the accelerated arm of the study. Those couples achieved pregnancy in an average of eight months compared with an average time to pregnancy of 11 months for couples in the conventional arm.
Insurance charge data were collected for 448 participating couples. Average charges per delivery were $9,800 lower in the accelerated arm than for conventional treatment. Savings of $2,624 per couple were observed in the accelerated treatment arm.
Dr. Reindollar’s co-investigators included Marlene B. Goldman Sc.D. of the Departments of Obstetrics and Gynecology and Community and Family Medicine, Dartmouth Medical School and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire; Meredith M. Regan Sc.D., Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts; Peter J. Neumann Sc.D., and Bat-Sheva Levine M.D., Center for the Evaluation of Value and Risk in Health, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts; Kim L. Thornton M.D., and Michael M. Alper M.D., Department of Obstetrics, Gynecology and Reproductive Biology, Division of Reproductive Endocrinology and Infertility, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, and Boston IVF, Waltham, Massachusetts.
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