Fertility and Sterility
Volume 94, Issue 4 , Pages 1287-1291, September 2010

Factors affecting success rates in two concurrent clinical IVF trials: an examination of potential explanations for the difference in pregnancy rates between the United States and Europe

  • Valerie L. Baker, M.D.

      Affiliations

    • Department of Obstetrics and Gynecology, Stanford University Medical Center, Stanford, California
    • Corresponding Author InformationReprint requests: Valerie L. Baker, M.D., Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Stanford University Medical Center, 300 Pasteur Drive, Room HH333, Stanford, CA 94305 (FAX: 650-498-4320).
  • ,
  • Clarence E. Jones, Ph.D.

      Affiliations

    • Institut Biochimique SA (IBSA), Lugano, Switzerland
  • ,
  • Barbara Cometti, Ph.D.

      Affiliations

    • Institut Biochimique SA (IBSA), Lugano, Switzerland
  • ,
  • Fred Hoehler, Ph.D.

      Affiliations

    • Biostatistician Consultant, Orange, California
  • ,
  • Bruno Salle, M.D., Ph.D., D.Sc.

      Affiliations

    • Medecine de la Reproduction, Hôpital Femme Mère Enfants, Bron, France, Université Claude Bernard, Lyon, France
  • ,
  • János Urbancsek, M.D.

      Affiliations

    • Semmelweis University, first Department of OB/GYN, Division of Assisted Reproduction, Department of Obstetrics and Gynaecology, Budapest, Hungary
  • ,
  • Michael R. Soules, M.D.

      Affiliations

    • Seattle Reproductive Medicine, Seattle, Washington

Received 23 April 2009; received in revised form 14 June 2009; accepted 21 July 2009. published online 07 October 2009.

Objective

To compare a US clinical trial of gonadotropin therapy for IVF with a similar European trial to determine what factors may explain the higher clinical pregnancy rate in the US trial.

Design

Comparison of baseline, treatment, and outcome variables in the United States (US) and European trials.

Setting

IVF practices in the US (n=4) and Europe (n=6).

Patient(s)

297 women undergoing IVF.

Intervention(s)

None.

Main Outcome Measure(s)

Clinical pregnancy rate.

Result(s)

Clinical pregnancy rates were 43.4% in the US compared with 29.7% in Europe (p=0.016), with a live birth rate of 38.2% versus 27.6% (p=0.064). This difference in clinical pregnancy rate could not be explained by differences in the US versus Europe for number of embryos transferred (2.3 vs. 2.6) or female age (34.6 vs. 30.4). Although the starting dose of gonadotropin was higher in the US trial compared with the European trial (300 versus 225 IU), the total dose of gonadotropin was only slightly higher in the US. In multiple logistic regression analysis of 81 pretransfer variables on clinical pregnancy, the only two found to be significant predictors of outcome were baseline endometrial thickness following down-regulation and number of days of gonadotropin treatment.

Conclusion(s)

This study suggests the possibility that US pregnancy rates may be higher in part because of differences in down-regulation or gonadotropin dosing. Other factors not assessed in these studies or in national datasets likely also contribute to the difference in pregnancy rates.

Key Words: In vitro fertilization, assisted reproductive technology, pregnancy rate, gonadotropin

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 V.L.B. has received IBSA research support. C.E.J. is an employee of IBSA. B.C. is an employee of IBSA. F.H. is a consultant for IBSA, Pioneer Surgical, and Vital Therapies. B.S. has nothing to disclose. J.U. has nothing to disclose. M.R.S. has nothing to disclose.

 The clinical trials used in this analysis were sponsored by Institut Biochimique SA (IBSA).

PII: S0015-0282(09)03466-9

doi:10.1016/j.fertnstert.2009.07.1673

Fertility and Sterility
Volume 94, Issue 4 , Pages 1287-1291, September 2010