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Mild Ovarian Stimulation With 1 Embryo Transferred May Be Effective as IVF
News Author: Laurie Barclay, MD
CME Author: Charles Vega, MD, FAAFP
Authors and Disclosures
CME Released: 03/06/2007; Valid for credit through 03/06/2008
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March 6, 2007 — Mild ovarian stimulation with 1 embryo transferred produced similar cumulative rates of term live births as did standard stimulation with 2 embryos transferred, according to the results of a randomized, noninferiority effectiveness trial reported in the March 3 issue of The Lancet.

"Mild in-vitro fertilisation (IVF) treatment might lessen both patients' discomfort and multiple births, with their associated risks," write Esther M. E. W. Heijnen, of the University Medical Centre in Utrecht, Netherlands, and colleagues. "We aimed to test the hypothesis that mild IVF treatment can achieve the same chance of a pregnancy resulting in term live birth within 1 year compared with standard treatment, and can also reduce patients' discomfort, multiple pregnancies, and costs."

In this study, 404 patients were randomized to undergo either mild treatment (mild ovarian stimulation with gonadotropin-releasing hormone [GnRH] antagonist co-treatment combined with single embryo transfer) or standard treatment (stimulation with a GnRH agonist long protocol and transfer of 2 embryos).

The main outcomes were proportion of cumulative pregnancies leading to term live birth within 1 year after randomization (with a noninferiority threshold of -12.5%), total costs per couple up to 6 weeks after expected delivery date, and overall patient discomfort. Analysis was by intent-to-treat.

The proportions of cumulative pregnancies that resulted in term live birth after 1 year were 43.4% with mild treatment and 44.7% with standard treatment (absolute number, 86 in each group; lower limit of 1-sided 95% confidence interval [CI], -9.8%). Multiple pregnancy occurred in 0.5% of couples in the mild IVF treatment group compared with 13.1% in the standard treatment group

Mean total costs were € 8333 and € 10,745, respectively (difference, € 2412; 95% CI, 703 - 4131). The groups did not differ significantly in terms of anxiety, depression, physical discomfort, or sleep quality of the mother.

"Over 1 year of treatment, cumulative rates of term live births and patients' discomfort are much the same for mild ovarian stimulation with single embryos transferred and for standard stimulation with two embryos transferred," the authors write. "However, a mild IVF treatment protocol can substantially reduce multiple pregnancy rates and overall costs."

Study limitations include 50% questionnaire response rate, and lower response rate in women who had no oocyte retrieval or embryo transfer.

"Our findings should encourage more widespread use of mild ovarian stimulation and single embryo transfer in clinical practice," the authors conclude. "However, adoption of our mild IVF treatment strategy would need to be supported by counselling of both patients and health-care providers to redefine IVF success and explain the risks associated with multiple pregnancies and by institution of reimbursement systems that encourage, rather than penalise, the practice of single embryo transfer."

The authors have disclosed various financial relationships with NV Organon, Oss, Netherlands.

In an accompanying editorial, William L. Ledger, MD, of the University of Sheffield in the United Kingdom, notes that an elective policy of single embryo transfer remains controversial in the United Kingdom.

"While 75% of IVF treatment in the UK continues to be paid for by patients themselves, and the guidance by the UK National Institute for Clinical Excellence in 2004 that all eligible couples are offered three full cycles of IVF remains a pipe dream, many couples will opt for double embryo transfer because it is much less costly," Dr. Ledger writes. "Governments should recognise the long-term benefits to patients, to neonatal and postnatal care, and to the public purse of implementing a policy of single embryo transfer and encouraging adoption of the policy with increased funding for such treatments."

Dr. Ledger has disclosed no relevant financial relationships.

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