Randomized Controlled Trial

. 2015 Apr;103(4):962-973.e4.

doi: 10.1016/j.fertnstert.2014.12.130. Epub 2015 Feb 20.

Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics

Michael P Diamond¹, Richard S Legro², Christos Coutifaris³, Ruben Alvero⁴, Randal D Robinson⁵, Peter Casson⁶, Gregory M Christman⁷, Joel Ager⁸, Hao Huang⁹, Karl R Hansen¹⁰, Valerie Baker¹¹, Rebecca Usadi¹², Aimee Seungdamrong¹³, G Wright Bates¹⁴, R Mitchell Rosen¹⁵, Daniel Haisonleder¹⁶, Stephen A Krawetz⁸, Kurt Barnhart³, J C Trussell¹⁷, Yufeng Jin⁹, Nanette Santoro⁴, Esther Eisenberg¹⁸, Heping Zhang⁹; National Institute of Child Health and Human Development (NICHD) Reproductive Medicine Network

Collaborators, Affiliations

Collaborators

National Institute of Child Health and Human Development (NICHD) Reproductive Medicine Network:
C Bartlebaugh, W Dodson, S Estes, C Gnatuk, R Ladda, J Ober, C Easton, A Hernandez, M Leija, D Pierce, R Brzyski, A Awonuga, L Cedo, A Cline, K Collins, E Puscheck, M Singh, M Yoscovits, K Lecks, L Martino, R Marunich, A Comfort, M Crow, A Hohmann, S Mallette, Y Smith, J Randolph, S Fisseha, M Ringbloom, J Tang, S Mason, N DiMaria, B Laylor, L Martinez, A Solnica, A Wojtczuk, M Rhea, K Turner, L B Craig, C Zornes, M R Rodriguez, T S Hunt, Thomas Remble, Gloria Cheng, Lauri Green, Nikolaus Lenhart, D DelBasso, M Brennan, H Kuang, Y Li, P Patrizio, L Sakai, C Song, H Taylor, T Thomas, Q Yan, M Zhang, C Lamar, L DePaolo, D Guzick, A Herring, J Bruce Redmond, M Thomas, P Turek, J Wactawski-Wende, R Rebar, P Cato, V Dukic, V Lewis, P Schlegel, F Witter

Affiliations

¹ Department of Obstetrics and Gynecology, Georgia Regents University, Augusta, Georgia; Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan. Electronic address: Michael.Diamond@gru.edu.
² Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania.
³ Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
⁴ Department of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.
⁵ Department of Obstetrics and Gynecology, University of Texas Health Science Center at San Antonio, San Antonio, Texas.
⁶ Department of Obstetrics and Gynecology, University of Vermont, Burlington, Vermont.
⁷ Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.
⁸ Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.
⁹ Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut.
¹⁰ Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.
¹¹ Stanford University Medical Center, Stanford, California.
¹² Carolinas Medical Center, Charlotte, North Carolina.
¹³ New Jersey Medical School - University of Medicine and Dentistry of New Jersey, Rutgers, New Jersey.
¹⁴ University of Alabama Birmingham, Birmingham, Alabama.
¹⁵ Department of Reproductive Endocrinology and Infertility, University of California, San Francisco, California.
¹⁶ Ligand Core Laboratory University of Virginia Center for Research in Reproduction, Charlottesville, Virginia.
¹⁷ Upstate University Hospital, Syracuse, New York.
¹⁸ Fertility and Infertility Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Maryland.

PMID: 25707331
PMCID: PMC4529113
DOI: 10.1016/j.fertnstert.2014.12.130

Randomized Controlled Trial

Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics

Michael P Diamond et al. Fertil Steril. 2015 Apr.

. 2015 Apr;103(4):962-973.e4.

doi: 10.1016/j.fertnstert.2014.12.130. Epub 2015 Feb 20.

Authors

Collaborators

National Institute of Child Health and Human Development (NICHD) Reproductive Medicine Network:
C Bartlebaugh, W Dodson, S Estes, C Gnatuk, R Ladda, J Ober, C Easton, A Hernandez, M Leija, D Pierce, R Brzyski, A Awonuga, L Cedo, A Cline, K Collins, E Puscheck, M Singh, M Yoscovits, K Lecks, L Martino, R Marunich, A Comfort, M Crow, A Hohmann, S Mallette, Y Smith, J Randolph, S Fisseha, M Ringbloom, J Tang, S Mason, N DiMaria, B Laylor, L Martinez, A Solnica, A Wojtczuk, M Rhea, K Turner, L B Craig, C Zornes, M R Rodriguez, T S Hunt, Thomas Remble, Gloria Cheng, Lauri Green, Nikolaus Lenhart, D DelBasso, M Brennan, H Kuang, Y Li, P Patrizio, L Sakai, C Song, H Taylor, T Thomas, Q Yan, M Zhang, C Lamar, L DePaolo, D Guzick, A Herring, J Bruce Redmond, M Thomas, P Turek, J Wactawski-Wende, R Rebar, P Cato, V Dukic, V Lewis, P Schlegel, F Witter

Affiliations

¹ Department of Obstetrics and Gynecology, Georgia Regents University, Augusta, Georgia; Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan. Electronic address: Michael.Diamond@gru.edu.
² Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania.
³ Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
⁴ Department of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.
⁵ Department of Obstetrics and Gynecology, University of Texas Health Science Center at San Antonio, San Antonio, Texas.
⁶ Department of Obstetrics and Gynecology, University of Vermont, Burlington, Vermont.
⁷ Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.
⁸ Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.
⁹ Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut.
¹⁰ Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.
¹¹ Stanford University Medical Center, Stanford, California.
¹² Carolinas Medical Center, Charlotte, North Carolina.
¹³ New Jersey Medical School - University of Medicine and Dentistry of New Jersey, Rutgers, New Jersey.
¹⁴ University of Alabama Birmingham, Birmingham, Alabama.
¹⁵ Department of Reproductive Endocrinology and Infertility, University of California, San Francisco, California.
¹⁶ Ligand Core Laboratory University of Virginia Center for Research in Reproduction, Charlottesville, Virginia.
¹⁷ Upstate University Hospital, Syracuse, New York.
¹⁸ Fertility and Infertility Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Maryland.

PMID: 25707331
PMCID: PMC4529113
DOI: 10.1016/j.fertnstert.2014.12.130

Abstract

Objective: To identify baseline characteristics of women with unexplained infertility to determine whether treatment with an aromatase inhibitor will result in a lower rate of multiple gestations than current standard ovulation induction medications.

Design: Randomized, prospective clinical trial.

Setting: Multicenter university-based clinical practices.

Patient(s): A total of 900 couples with unexplained infertility.

Intervention(s): Collection of baseline demographics, blood samples, and ultrasonographic assessments.

Main outcome measure(s): Demographic, laboratory, imaging, and survey characteristics.

Result(s): Demographic characteristics of women receiving clomiphene citrate (CC), letrozole, or gonadotropins for ovarian stimulation were very consistent. Their mean age was 32.2 ± 4.4 years and infertility duration was 34.7 ± 25.7 months, with 59% primary infertility. More than one-third of the women were current or past smokers. The mean body mass index (BMI) was 27 and mean antimüllerian hormone level was 2.6; only 11 women (1.3%) had antral follicle counts of <5. Similar observations were identified for hormonal profiles, ultrasound characterization of the ovaries, semen parameters, and quality of life assessments in both male and female partners.

Conclusion(s): The cause of infertility in the couples recruited to this treatment trial is elusive, as the women were regularly ovulating and had evidence of good ovarian reserve both by basal FSH, antimüllerian hormone levels, and antral follicle counts; the male partners had normal semen parameters. The three treatment groups have common baseline characteristics, thereby providing comparable patient populations for testing the hypothesis that use of letrozole for ovarian stimulation can reduce the rates of multiples from that observed with gonadotropin and CC treatment.

Clinical trial registration number: NCT 01044862.

Trial registration: ClinicalTrials.gov NCT01044862.

Keywords: Unexplained infertility; aromatase inhibitors; clomiphene citrate; gonadotropins; letrozole; multiple gestations.

PubMed Disclaimer

Comment in

In defense of publishing baseline data from clinical trials.
Legro RS. Legro RS. Fertil Steril. 2015 Apr;103(4):902-3. doi: 10.1016/j.fertnstert.2015.01.039. Epub 2015 Feb 21. Fertil Steril. 2015. PMID: 25712574 No abstract available.

References

1. Dodson WC, Whitesides DB, Hughes CL, Jr, Easley HA, 3rd, Haney AF. Superovulation with intrauterine insemination in the treatment of infertility: a possible alternative to gamete intrafallopian transfer and in vitro fertilization. Fertility and sterility. 1987;48:441–445. - PubMed
1. Steures P, van der Steeg JW, Hompes PG, Habbema JD, Eijkemans MJ, Broekmans FJ, et al. Intrauterine insemination with controlled ovarian hyperstimulation versus expectant management for couples with unexplained subfertility and an intermediate prognosis: a randomised clinical trial. Lancet. 2006;368:216–221. - PubMed
1. Guzick DS, Carson SA, Coutifaris C, Overstreet JW, Factor-Litvak P, Steinkampf MP, et al. Efficacy of superovulation and intrauterine insemination in the treatment of infertility. National Cooperative Reproductive Medicine Network. The New England journal of medicine. 1999;340:177–183. - PubMed
1. Diamond MP, Mitwally M, Casper R, Ager J, Legro RS, Brzyski R, et al. Estimating rates of multiple gestation pregnancies: sample size calculation from the assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial. Contemporary clinical trials. 2011;32:902–908. - PMC - PubMed
1. Martin JA, Hamilton BE, Ventura SJ, Menacker F, Park MM, Sutton PD. Births: final data for 2001. National vital statistics reports : from the Centers for Disease Control and Prevention, National Center for Health Statistics, National Vital Statistics System. 2002;51:1–102. - PubMed

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Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics

Collaborators

Affiliations

Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics

Authors

Collaborators

Affiliations

Abstract

Comment in

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical

Molecular Biology Databases

Miscellaneous