TY - JOUR
T1 - Pregnancy registry
T2 - three-year follow-up of children conceived from letrozole, clomiphene, or gonadotropins
AU - Reproductive Medicine Network
AU - Legro, Richard S.
AU - Diamond, Michael P.
AU - Coutifaris, Christos
AU - Schlaff, William D.
AU - Alvero, Ruben
AU - Casson, Peter
AU - Christman, Gregory M.
AU - Rosen, R. Mitchell
AU - Cedars, Marcelle I.
AU - Hansen, Karl R.
AU - Robinson, Randal
AU - Baker, Valerie
AU - Usadi, Rebecca
AU - Dodson, William C.
AU - Estes, Stephanie J.
AU - Kunselman, Allen
AU - Stetter, Christina
AU - Barnhart, Kurt T.
AU - Coward, R. Matthew
AU - Trussell, J. C.
AU - Krawetz, Stephen A.
AU - Santoro, Nanette
AU - Huang, Hao
AU - Zhang, Heping
AU - Eisenberg, Esther
N1 - Funding Information:
This work was supported by National Institutes of Health (NIH)/Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) grants U10 HD27049(to C.C.), U10 HD38992 (to R.S.L.), U10HD055925 (to H.Z.), U10 HD39005 (to M.P.D.), U10 HD38998 (to W.D.S), U10 HD055936 (to G.M.C.), U10 HD055942 (to R.G.B.), and U10 HD055944 (to P.R.C.); U54-HD29834 (to the University of Virginia Center for Research in Reproduction Ligand Assay and Analysis Core of the Specialized Cooperative Centers Program in Reproduction and Infertility Research); and General Clinical Research Center grant MO1RR10732 and construction grant C06 RR016499 (to Pennsylvania State University). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NICHD or NIH. R.S.L. reports consulting fees from Ferring, Bayer, Abbvie, and Fractyl and research sponsorship from Ferring and Guerbet. M.P.D. reports institutional grants/contracts from Bayer, ObsEva, and AbbVie; serving as a member of the board of directors and a stockholder of Advanced Reproductive Care; and serving as a consultant for Seikagaku, Actamax, AEGEA, Temple Therapeutics, and ARC Medical Devices. C.C. has nothing to disclose. W.D.S. reports research funding from Abbvie. R.A. has nothing to disclose. P.C. has nothing to disclose. G.M.C. has nothing to disclose. R.M.R. has nothing to disclose. M.I.C. has nothing to disclose. K.R.H. reports research grants from Roche Diagnostics and Ferring outside of the submitted work. R.R. has nothing to disclose. V.B. has nothing to disclose. R.U. has nothing to disclose. W.C.D. has nothing to disclose. S.J.E. has nothing to disclose. A.K. reports ownership of stock in Merck outside of the submitted work. C.S. has nothing to disclose. K.T.B. has nothing to disclose. R.M.C. has nothing to disclose. J.C.T. has nothing to disclose. S.A.K. reports research grant from Merck outside of the submitted work. N.S. has nothing to disclose. H.H. has nothing to disclose. H.Z. has nothing to disclose. E.E. has nothing to disclose.
Funding Information:
This work was supported by National Institutes of Health (NIH)/ Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) grants U10 HD27049 (to C.C.), U10 HD38992 (to R.S.L.), U10HD055925 (to H.Z.), U10 HD39005 (to M.P.D.), U10 HD38998 (to W.D.S), U10 HD055936 (to G.M.C.), U10 HD055942 (to R.G.B.), and U10 HD055944 (to P.R.C.); U54-HD29834 (to the University of Virginia Center for Research in Reproduction Ligand Assay and Analysis Core of the Specialized Cooperative Centers Program in Reproduction and Infertility Research); and General Clinical Research Center grant MO1RR10732 and construction grant C06 RR016499 (to Pennsylvania State University). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NICHD or NIH.
Funding Information:
R.S.L. reports consulting fees from Ferring, Bayer, Abbvie, and Fractyl and research sponsorship from Ferring and Guerbet. M.P.D. reports institutional grants/contracts from Bayer, ObsEva, and AbbVie; serving as a member of the board of directors and a stockholder of Advanced Reproductive Care; and serving as a consultant for Seikagaku, Actamax, AEGEA, Temple Therapeutics, and ARC Medical Devices. C.C. has nothing to disclose. W.D.S. reports research funding from Abbvie. R.A. has nothing to disclose. P.C. has nothing to disclose. G.M.C. has nothing to disclose. R.M.R. has nothing to disclose. M.I.C. has nothing to disclose. K.R.H. reports research grants from Roche Diagnostics and Ferring outside of the submitted work. R.R. has nothing to disclose. V.B. has nothing to disclose. R.U. has nothing to disclose. W.C.D. has nothing to disclose. S.J.E. has nothing to disclose. A.K. reports ownership of stock in Merck outside of the submitted work. C.S. has nothing to disclose. K.T.B. has nothing to disclose. R.M.C. has nothing to disclose. J.C.T. has nothing to disclose. S.A.K. reports research grant from Merck outside of the submitted work. N.S. has nothing to disclose. H.H. has nothing to disclose. H.Z. has nothing to disclose. E.E. has nothing to disclose.
Publisher Copyright:
© 2020
PY - 2020/5
Y1 - 2020/5
N2 - Objective: To study the development of children conceived from non-IVF infertility treatments consisting of gonadotropins, clomiphene, or letrozole. Design: Prospective cohort study. Setting: U.S. academic health centers. Patient(s): Children of women with polycystic ovary syndrome who conceived with letrozole (LTZ) or clomiphene (CC) in the PPCOS II study or women with unexplained infertility (AMIGOS study) who conceived with LTZ, CC, or gonadotropin (GN). Intervention(s): Longitudinal annual follow-up from birth to age 3. Main Outcome Measure(s): Scores from Ages and Stages Developmental Questionnaire (ASQ), MacArthur-Bates Communicative Development Inventory (MCDI), and annual growth. Result(s): One hundred eighty-five children from 160 families participated in at least one follow-up evaluation from the two infertility trials. Most multiple gestations in the follow-up study resulted from GN treatment (n = 14) followed by CC (n = 6) and LTZ (n = 3). There were no significant differences among the three groups at any time point with respect to abnormal scores on the ASQ. On the MCDI Words and Gestures, the LTZ group scored significantly higher than the GN group for most items (phrases, early gestures, later gestures, and total gestures). Children in the CC group scored significantly higher than the GN group for the later gestures and total gestures items. Conclusion(s): Differences in growth and cognitive developmental rates among children conceived with first-line infertility therapies, including LTZ, are relatively minor and likely due to differences in multiple pregnancy rates.
AB - Objective: To study the development of children conceived from non-IVF infertility treatments consisting of gonadotropins, clomiphene, or letrozole. Design: Prospective cohort study. Setting: U.S. academic health centers. Patient(s): Children of women with polycystic ovary syndrome who conceived with letrozole (LTZ) or clomiphene (CC) in the PPCOS II study or women with unexplained infertility (AMIGOS study) who conceived with LTZ, CC, or gonadotropin (GN). Intervention(s): Longitudinal annual follow-up from birth to age 3. Main Outcome Measure(s): Scores from Ages and Stages Developmental Questionnaire (ASQ), MacArthur-Bates Communicative Development Inventory (MCDI), and annual growth. Result(s): One hundred eighty-five children from 160 families participated in at least one follow-up evaluation from the two infertility trials. Most multiple gestations in the follow-up study resulted from GN treatment (n = 14) followed by CC (n = 6) and LTZ (n = 3). There were no significant differences among the three groups at any time point with respect to abnormal scores on the ASQ. On the MCDI Words and Gestures, the LTZ group scored significantly higher than the GN group for most items (phrases, early gestures, later gestures, and total gestures). Children in the CC group scored significantly higher than the GN group for the later gestures and total gestures items. Conclusion(s): Differences in growth and cognitive developmental rates among children conceived with first-line infertility therapies, including LTZ, are relatively minor and likely due to differences in multiple pregnancy rates.
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UR - http://www.scopus.com/inward/citedby.url?scp=85084176821&partnerID=8YFLogxK
U2 - 10.1016/j.fertnstert.2019.12.023
DO - 10.1016/j.fertnstert.2019.12.023
M3 - Article
C2 - 32386612
AN - SCOPUS:85084176821
SN - 0015-0282
VL - 113
SP - 1005
EP - 1013
JO - Fertility and Sterility
JF - Fertility and Sterility
IS - 5
ER -