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

Michael Peter Diamond, Richard S. Legro, Christos Coutifaris, Ruben Alvero, Randal D. Robinson, Peter Casson, Gregory M. Christman, Joel Ager, Hao Huang, Karl R. Hansen, Valerie Baker, Rebecca Usadi, Aimee Seungdamrong, G. Wright Bates, R. Mitchell Rosen, Daniel Haisonleder, Stephen A. Krawetz, Kurt Barnhart, J. C. Trussell, Yufeng JinNanette Santoro, Esther Eisenberg, Heping Zhang, 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. Di Maria, 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. Del Basso, M. Brennan, H. Kuang, Y. Li, P. Patrizio, L. Sakai, C. Song, H. Taylor, T. Thomas, Q. Yan, M. Zhang, C. Lamar, L. De Paolo, 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

Research output: Contribution to journalArticle

19 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)962-973.e4
JournalFertility and sterility
Volume103
Issue number4
DOIs
StatePublished - Jan 1 2015

Fingerprint

Ovulation Induction
letrozole
Infertility
Pregnancy
Clomiphene
Demography
Gonadotropins
Hormones
Aromatase Inhibitors
Semen Analysis
Therapeutics
Semen
Ovary
Body Mass Index
Randomized Controlled Trials
Quality of Life
Outcome Assessment (Health Care)
Clinical Trials
Population
Antral

Keywords

  • Aromatase inhibitors
  • Clomiphene citrate
  • Gonadotropins
  • Letrozole
  • Multiple gestations
  • Unexplained infertility

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial : Baseline characteristics. / Diamond, Michael Peter; Legro, Richard S.; Coutifaris, Christos; Alvero, Ruben; Robinson, Randal D.; Casson, Peter; Christman, Gregory M.; Ager, Joel; Huang, Hao; Hansen, Karl R.; Baker, Valerie; Usadi, Rebecca; Seungdamrong, Aimee; Bates, G. Wright; Rosen, R. Mitchell; Haisonleder, Daniel; Krawetz, Stephen A.; Barnhart, Kurt; Trussell, J. C.; Jin, Yufeng; Santoro, Nanette; Eisenberg, Esther; Zhang, Heping; Bartlebaugh, C.; Dodson, W.; Estes, S.; Gnatuk, C.; Ladda, R.; Ober, J.; Easton, C.; Hernandez, A.; Leija, M.; Pierce, D.; Brzyski, R.; Awonuga, A.; Cedo, L.; Cline, A.; Collins, K.; Puscheck, E.; Singh, M.; Yoscovits, M.; Lecks, K.; Martino, L.; Marunich, R.; Comfort, A.; Crow, M.; Hohmann, A.; Mallette, S.; Smith, Y.; Randolph, J.; Fisseha, S.; Ringbloom, M.; Tang, J.; Mason, S.; Di Maria, N.; Laylor, B.; Martinez, L.; Solnica, A.; Wojtczuk, A.; Rhea, M.; Turner, K.; Craig, L. B.; Zornes, C.; Rodriguez, M. R.; Hunt, T. S.; Remble, Thomas; Cheng, Gloria; Green, Lauri; Lenhart, Nikolaus; Del Basso, D.; Brennan, M.; Kuang, H.; Li, Y.; Patrizio, P.; Sakai, L.; Song, C.; Taylor, H.; Thomas, T.; Yan, Q.; Zhang, M.; Lamar, C.; De Paolo, L.; Guzick, D.; Herring, A.; Redmond, J. Bruce; Thomas, M.; Turek, P.; Wactawski-Wende, J.; Rebar, R.; Cato, P.; Dukic, V.; Lewis, V.; Schlegel, P.; Witter, F.

In: Fertility and sterility, Vol. 103, No. 4, 01.01.2015, p. 962-973.e4.

Research output: Contribution to journalArticle

Diamond, MP, Legro, RS, Coutifaris, C, Alvero, R, Robinson, RD, Casson, P, Christman, GM, Ager, J, Huang, H, Hansen, KR, Baker, V, Usadi, R, Seungdamrong, A, Bates, GW, Rosen, RM, Haisonleder, D, Krawetz, SA, Barnhart, K, Trussell, JC, Jin, Y, Santoro, N, Eisenberg, E, Zhang, H, Bartlebaugh, C, Dodson, W, Estes, S, Gnatuk, C, Ladda, R, Ober, J, Easton, C, Hernandez, A, Leija, M, Pierce, D, Brzyski, R, Awonuga, A, Cedo, L, Cline, A, Collins, K, Puscheck, E, Singh, M, Yoscovits, M, Lecks, K, Martino, L, Marunich, R, Comfort, A, Crow, M, Hohmann, A, Mallette, S, Smith, Y, Randolph, J, Fisseha, S, Ringbloom, M, Tang, J, Mason, S, Di Maria, N, Laylor, B, Martinez, L, Solnica, A, Wojtczuk, A, Rhea, M, Turner, K, Craig, LB, Zornes, C, Rodriguez, MR, Hunt, TS, Remble, T, Cheng, G, Green, L, Lenhart, N, Del Basso, D, Brennan, M, Kuang, H, Li, Y, Patrizio, P, Sakai, L, Song, C, Taylor, H, Thomas, T, Yan, Q, Zhang, M, Lamar, C, De Paolo, L, Guzick, D, Herring, A, Redmond, JB, Thomas, M, Turek, P, Wactawski-Wende, J, Rebar, R, Cato, P, Dukic, V, Lewis, V, Schlegel, P & Witter, F 2015, 'Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: Baseline characteristics', Fertility and sterility, vol. 103, no. 4, pp. 962-973.e4. https://doi.org/10.1016/j.fertnstert.2014.12.130
Diamond, Michael Peter ; Legro, Richard S. ; Coutifaris, Christos ; Alvero, Ruben ; Robinson, Randal D. ; Casson, Peter ; Christman, Gregory M. ; Ager, Joel ; Huang, Hao ; Hansen, Karl R. ; Baker, Valerie ; Usadi, Rebecca ; Seungdamrong, Aimee ; Bates, G. Wright ; Rosen, R. Mitchell ; Haisonleder, Daniel ; Krawetz, Stephen A. ; Barnhart, Kurt ; Trussell, J. C. ; Jin, Yufeng ; Santoro, Nanette ; Eisenberg, Esther ; Zhang, Heping ; Bartlebaugh, C. ; Dodson, W. ; Estes, S. ; Gnatuk, C. ; Ladda, R. ; Ober, J. ; Easton, C. ; Hernandez, A. ; Leija, M. ; Pierce, D. ; Brzyski, R. ; Awonuga, A. ; Cedo, L. ; Cline, A. ; Collins, K. ; Puscheck, E. ; Singh, M. ; Yoscovits, M. ; Lecks, K. ; Martino, L. ; Marunich, R. ; Comfort, A. ; Crow, M. ; Hohmann, A. ; Mallette, S. ; Smith, Y. ; Randolph, J. ; Fisseha, S. ; Ringbloom, M. ; Tang, J. ; Mason, S. ; Di Maria, N. ; Laylor, B. ; Martinez, L. ; Solnica, A. ; Wojtczuk, A. ; Rhea, M. ; Turner, K. ; Craig, L. B. ; Zornes, C. ; Rodriguez, M. R. ; Hunt, T. S. ; Remble, Thomas ; Cheng, Gloria ; Green, Lauri ; Lenhart, Nikolaus ; Del Basso, D. ; Brennan, M. ; Kuang, H. ; Li, Y. ; Patrizio, P. ; Sakai, L. ; Song, C. ; Taylor, H. ; Thomas, T. ; Yan, Q. ; Zhang, M. ; Lamar, C. ; De Paolo, L. ; Guzick, D. ; Herring, A. ; Redmond, J. Bruce ; Thomas, M. ; Turek, P. ; Wactawski-Wende, J. ; Rebar, R. ; Cato, P. ; Dukic, V. ; Lewis, V. ; Schlegel, P. ; Witter, F. / Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial : Baseline characteristics. In: Fertility and sterility. 2015 ; Vol. 103, No. 4. pp. 962-973.e4.
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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 antim{\"u}llerian 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, antim{\"u}llerian 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.",
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TY - JOUR

T1 - Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial

T2 - Baseline characteristics

AU - Diamond, Michael Peter

AU - Legro, Richard S.

AU - Coutifaris, Christos

AU - Alvero, Ruben

AU - Robinson, Randal D.

AU - Casson, Peter

AU - Christman, Gregory M.

AU - Ager, Joel

AU - Huang, Hao

AU - Hansen, Karl R.

AU - Baker, Valerie

AU - Usadi, Rebecca

AU - Seungdamrong, Aimee

AU - Bates, G. Wright

AU - Rosen, R. Mitchell

AU - Haisonleder, Daniel

AU - Krawetz, Stephen A.

AU - Barnhart, Kurt

AU - Trussell, J. C.

AU - Jin, Yufeng

AU - Santoro, Nanette

AU - Eisenberg, Esther

AU - Zhang, Heping

AU - Bartlebaugh, C.

AU - Dodson, W.

AU - Estes, S.

AU - Gnatuk, C.

AU - Ladda, R.

AU - Ober, J.

AU - Easton, C.

AU - Hernandez, A.

AU - Leija, M.

AU - Pierce, D.

AU - Brzyski, R.

AU - Awonuga, A.

AU - Cedo, L.

AU - Cline, A.

AU - Collins, K.

AU - Puscheck, E.

AU - Singh, M.

AU - Yoscovits, M.

AU - Lecks, K.

AU - Martino, L.

AU - Marunich, R.

AU - Comfort, A.

AU - Crow, M.

AU - Hohmann, A.

AU - Mallette, S.

AU - Smith, Y.

AU - Randolph, J.

AU - Fisseha, S.

AU - Ringbloom, M.

AU - Tang, J.

AU - Mason, S.

AU - Di Maria, N.

AU - Laylor, B.

AU - Martinez, L.

AU - Solnica, A.

AU - Wojtczuk, A.

AU - Rhea, M.

AU - Turner, K.

AU - Craig, L. B.

AU - Zornes, C.

AU - Rodriguez, M. R.

AU - Hunt, T. S.

AU - Remble, Thomas

AU - Cheng, Gloria

AU - Green, Lauri

AU - Lenhart, Nikolaus

AU - Del Basso, D.

AU - Brennan, M.

AU - Kuang, H.

AU - Li, Y.

AU - Patrizio, P.

AU - Sakai, L.

AU - Song, C.

AU - Taylor, H.

AU - Thomas, T.

AU - Yan, Q.

AU - Zhang, M.

AU - Lamar, C.

AU - De Paolo, L.

AU - Guzick, D.

AU - Herring, A.

AU - Redmond, J. Bruce

AU - Thomas, M.

AU - Turek, P.

AU - Wactawski-Wende, J.

AU - Rebar, R.

AU - Cato, P.

AU - Dukic, V.

AU - Lewis, V.

AU - Schlegel, P.

AU - Witter, F.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - 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.

AB - 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.

KW - Aromatase inhibitors

KW - Clomiphene citrate

KW - Gonadotropins

KW - Letrozole

KW - Multiple gestations

KW - Unexplained infertility

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