Estimating rates of multiple gestation pregnancies: Sample size calculation from the assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Wayne Sate University, 3800 Woodward Avenue, Suite 320, Detroit, MI 48201, USA.
Contemporary clinical trials (Impact Factor: 1.94). 07/2011; 32(6):902-8. DOI: 10.1016/j.cct.2011.07.009
Source: PubMed


Infertility afflicts 15% of couples who wish to conceive. Despite intensive evaluation of both male and female partners, the etiology may remain unknown leading to a diagnosis of unexplained infertility. For such couples, treatment often entails ovulation induction (OI) with fertility medications coupled with intrauterine insemination. Complications of this therapy include ovarian hyperstimulation syndrome and creation of multiple gestation pregnancies, which can be complicated by preterm labor and delivery, and the associated neonatal morbidity and expense of care for preterm infants. The Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) study is designed to assess whether OI in couples with unexplained infertility with an aromatase inhibitor produces mono-follicular development in most cycles, thereby reducing multiple gestations while maintaining a comparable pregnancy success rate to that achieved by OI with either gonadotropins or clomiphene citrate. These results will provide future guidance of therapy for couples with unexplained infertility, and if comparable pregnancy rates are achieved with a substantial reduction in multiple gestations, the public health benefit will be considerable.

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    • "The second study Assessment of Multiple Intra Uterine Gestations from ovarian stimulation (AMIGOS) trial will determine multiple pregnancy rates from OI and intrauterine insemination and is double blinded for CC or aromatase use.[45] Cumulative and multiple pregnancy rates will be calculated in a total of 240 women. "
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    ABSTRACT: Aromatase inhibitor "letrozole" was first introduced as a potential ovulation induction (OI) drug almost a decade back. Large number of studies has been published using letrozole for OI: In polycystic ovary syndrome (PCOS) women, clomiphene citrate (CC) resistant women, for intrauterine insemination and also in various protocols of mild stimulation for in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI). Letrozole appears to be a good option, with its oral route of administration, cost, shorter half-life and negligible side effects. However, the verdict on efficacy and safety of letrozole is still uncertain. This review explores the current scientific data supporting letrozole for OI.
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    ABSTRACT: Gonadotropins are a valuable part of the armamentarium available to assist couples in achieving a live birth. Multiple approaches can be used to limit the risk of multiple gestations, but with potential negative impact on establishing pregnancies. Financial considerations often limit enthusiasm for approaches which could reduce success in achieving pregnancy.
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    ABSTRACT: Ovarian stimulation and intrauterine insemination (OS/IUI), a mainstay of current infertility therapy and a common antecedent to IVF, is a significant driver of the multiple births epidemic. Redress of this challenge, now marking its quarter centennial, will require a rethinking of current practice patterns. Herein we explore prospects for prevention, mitigation, and eventual resolution. We conclude that the multiple births attributable to OS/IUI may not be entirely preventable but that the outlook for their mitigation is promising, if in need of solidification. Specifically, we observe that low-dose (≤ 75 IU) gondotropin, clomiphene, and especially off-label letrozole regimens outperform high-dose (≥ 150 IU) gonadotropin counterparts in the gestational plurality category while maintaining comparable per-cycle pregnancy rates. Accordingly we recommend that, subject to appropriate exceptions, high-dose gonadotropin regimens be used sparingly and that whenever possible they be replaced with emerging alternatives. Finally, we posit that OS/IUI is not likely to be superseded by IVF absent further commoditization and thus greater affordability.
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