{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T00:00:06Z","timestamp":1778716806992,"version":"3.51.4"},"reference-count":48,"publisher":"Elsevier BV","issue":"3","license":[{"start":{"date-parts":[[2012,5,1]],"date-time":"2012-05-01T00:00:00Z","timestamp":1335830400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Contemporary Clinical Trials"],"published-print":{"date-parts":[[2012,5]]},"DOI":"10.1016\/j.cct.2011.12.005","type":"journal-article","created":{"date-parts":[[2012,1,13]],"date-time":"2012-01-13T22:31:12Z","timestamp":1326493872000},"page":"470-481","source":"Crossref","is-referenced-by-count":52,"title":["The Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial: Rationale and design of a double-blind randomized trial of clomiphene citrate and letrozole for the treatment of infertility in women with polycystic ovary syndrome"],"prefix":"10.1016","volume":"33","clinical-trial-number":[{"clinical-trial-number":"nct00719186","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Richard S.","family":"Legro","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Allen R.","family":"Kunselman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert G.","family":"Brzyski","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter R.","family":"Casson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael P.","family":"Diamond","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William D.","family":"Schlaff","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gregory M.","family":"Christman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christos","family":"Coutifaris","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hugh S.","family":"Taylor","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Esther","family":"Eisenberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nanette","family":"Santoro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heping","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.cct.2011.12.005_bb0005","doi-asserted-by":"crossref","first-page":"235","DOI":"10.3109\/09513598709023610","article-title":"Epidemiology of infertility and polycystic ovarian disease: endocrinological and demographic studies","volume":"1","author":"Hull","year":"1987","journal-title":"Gynecol Endocrinol"},{"key":"10.1016\/j.cct.2011.12.005_bb0010","doi-asserted-by":"crossref","first-page":"1024","DOI":"10.1136\/bmj.297.6655.1024","article-title":"Influence of serum luteinising hormone concentrations on ovulation, conception, and early pregnancy loss in polycystic ovary syndrome","volume":"297","author":"Homburg","year":"1988","journal-title":"BMJ"},{"issue":"2","key":"10.1016\/j.cct.2011.12.005_bb0015","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1159\/000067719","article-title":"Impact of insulin resistance on pregnancy complications and outcome in women with polycystic ovary syndrome","volume":"54","author":"Bjercke","year":"2002","journal-title":"Gynecol Obstet Invest"},{"issue":"12","key":"10.1016\/j.cct.2011.12.005_bb0020","doi-asserted-by":"crossref","first-page":"1223","DOI":"10.1056\/NEJMra041536","article-title":"Polycystic ovary syndrome","volume":"352","author":"Ehrmann","year":"2005","journal-title":"N Engl J Med"},{"issue":"1","key":"10.1016\/j.cct.2011.12.005_bb0025","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1016\/j.fertnstert.2003.10.004","article-title":"Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome","volume":"81","year":"2004","journal-title":"Fertil Steril"},{"issue":"8","key":"10.1016\/j.cct.2011.12.005_bb0030","doi-asserted-by":"crossref","first-page":"1697","DOI":"10.1093\/humrep\/deh322","article-title":"Surrogate end-points or primary outcomes in clinical trials in women with polycystic ovary syndrome?","volume":"19","author":"Legro","year":"2004","journal-title":"Hum Reprod"},{"issue":"2","key":"10.1016\/j.cct.2011.12.005_bb0035","doi-asserted-by":"crossref","first-page":"141","DOI":"10.1111\/j.1479-828X.2006.00544.x","article-title":"No more surrogate end-points in randomised trials: the PCOSMIC trial protocol for women with polycystic ovary syndrome using metformin for infertility with clomiphene","volume":"46","author":"Johnson","year":"2006","journal-title":"Aust N Z J Obstet Gynaecol"},{"issue":"6","key":"10.1016\/j.cct.2011.12.005_bb0040","doi-asserted-by":"crossref","first-page":"551","DOI":"10.1056\/NEJMoa063971","article-title":"Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome","volume":"356","author":"Legro","year":"2007","journal-title":"N Engl J Med"},{"issue":"6","key":"10.1016\/j.cct.2011.12.005_bb0045","doi-asserted-by":"crossref","first-page":"1761","DOI":"10.1016\/j.fertnstert.2006.03.014","article-title":"Congenital malformations among 911 newborns conceived after infertility treatment with letrozole or clomiphene citrate","volume":"85","author":"Tulandi","year":"2006","journal-title":"Fertil Steril"},{"issue":"2","key":"10.1016\/j.cct.2011.12.005_bb0050","doi-asserted-by":"crossref","first-page":"277","DOI":"10.1016\/j.fertnstert.2005.05.078","article-title":"A new era in ovulation induction","volume":"85","author":"Holzer","year":"2006","journal-title":"Fertil Steril"},{"issue":"6","key":"10.1016\/j.cct.2011.12.005_bb0055","doi-asserted-by":"crossref","first-page":"1587","DOI":"10.1016\/j.fertnstert.2004.04.059","article-title":"A phase I study of the pharmacokinetics, pharmacodynamics, and safety of single- and multiple-dose anastrozole in healthy, premenopausal female volunteers","volume":"82","author":"Tredway","year":"2004","journal-title":"Fertil Steril"},{"issue":"1","key":"10.1016\/j.cct.2011.12.005_bb0060","doi-asserted-by":"crossref","first-page":"73","DOI":"10.1177\/147323000603400109","article-title":"Comparison of letrozole and clomiphene citrate in women with polycystic ovaries undergoing ovarian stimulation","volume":"34","author":"Atay","year":"2006","journal-title":"J Int Med Res"},{"issue":"4","key":"10.1016\/j.cct.2011.12.005_bb0065","doi-asserted-by":"crossref","first-page":"1045","DOI":"10.1016\/j.fertnstert.2005.09.045","article-title":"Letrozole vs. clomiphene citrate in patients with ovulatory infertility","volume":"85","author":"Bayar","year":"2006","journal-title":"Fertil Steril"},{"issue":"2","key":"10.1016\/j.cct.2011.12.005_bb0070","doi-asserted-by":"crossref","first-page":"305","DOI":"10.1016\/S0015-0282(00)01705-2","article-title":"Use of an aromatase inhibitor for induction of ovulation in patients with an inadequate response to clomiphene citrate","volume":"75","author":"Mitwally","year":"2001","journal-title":"Fertil Steril"},{"issue":"3","key":"10.1016\/j.cct.2011.12.005_bb0075","doi-asserted-by":"crossref","first-page":"289","DOI":"10.1016\/j.ijgo.2003.11.010","article-title":"Comparison of two aromatase inhibitors in women with clomiphene-resistant polycystic ovary syndrome","volume":"85","author":"Al-Omari","year":"2004","journal-title":"Int J Gynaecol Obstet"},{"issue":"2","key":"10.1016\/j.cct.2011.12.005_bb0080","doi-asserted-by":"crossref","first-page":"511","DOI":"10.1016\/j.fertnstert.2005.08.016","article-title":"Letrozole induction of ovulation in women with clomiphene citrate-resistant polycystic ovary syndrome may not depend on the period of infertility, the body mass index, or the luteinizing hormone\/follicle-stimulating hormone ratio","volume":"85","author":"Elnashar","year":"2006","journal-title":"Fertil Steril"},{"issue":"7","key":"10.1016\/j.cct.2011.12.005_bb0085","doi-asserted-by":"crossref","first-page":"815","DOI":"10.1016\/0002-9378(81)90746-8","article-title":"Hirsutism: implications, etiology, and management","volume":"140","author":"Hatch","year":"1981","journal-title":"Am J Obstet Gynecol"},{"issue":"2","key":"10.1016\/j.cct.2011.12.005_bb0090","doi-asserted-by":"crossref","first-page":"525","DOI":"10.1210\/jc.2003-030680","article-title":"Measurement of free testosterone in normal women and women with androgen deficiency: comparison of methods","volume":"89","author":"Miller","year":"2004","journal-title":"J Clin Endocrinol Metab"},{"issue":"6","key":"10.1016\/j.cct.2011.12.005_bb0095","doi-asserted-by":"crossref","first-page":"505","DOI":"10.1093\/humupd\/dmg044","article-title":"Ultrasound assessment of the polycystic ovary: international consensus definitions","volume":"9","author":"Balen","year":"2003","journal-title":"Hum Reprod Update"},{"issue":"2","key":"10.1016\/j.cct.2011.12.005_bb0100","first-page":"145","article-title":"The efficacy and safety of adapalene gel 0.3% in the treatment of acne vulgaris: a randomized, multicenter, investigator-blinded, controlled comparison study versus adapalene gel 0.1% and vehicle","volume":"76","author":"Pariser","year":"2005","journal-title":"Cutis"},{"issue":"3","key":"10.1016\/j.cct.2011.12.005_bb0105","doi-asserted-by":"crossref","first-page":"138","DOI":"10.1111\/j.1540-9740.2005.04279.x","article-title":"Combination therapy with adapalene gel 0.1% and doxycycline for severe acne vulgaris: a multicenter, investigator-blind, randomized, controlled study","volume":"4","author":"Thiboutot","year":"2005","journal-title":"Skinmed"},{"issue":"2","key":"10.1016\/j.cct.2011.12.005_bb0110","doi-asserted-by":"crossref","first-page":"216","DOI":"10.1016\/j.clinthera.2005.02.009","article-title":"Topical retinoids in inflammatory acne: a retrospective, investigator-blinded, vehicle-controlled, photographic assessment","volume":"27","author":"Leyden","year":"2005","journal-title":"Clin Ther"},{"issue":"5","key":"10.1016\/j.cct.2011.12.005_bb0115","doi-asserted-by":"crossref","first-page":"605","DOI":"10.1001\/archderm.142.5.605","article-title":"Comparison of tazarotene and minocycline maintenance therapies in acne vulgaris: a multicenter, double-blind, randomized, parallel-group study","volume":"142","author":"Leyden","year":"2006","journal-title":"Arch Dermatol"},{"issue":"5","key":"10.1016\/j.cct.2011.12.005_bb0120","doi-asserted-by":"crossref","first-page":"597","DOI":"10.1001\/archderm.142.5.597","article-title":"Adapalene gel, 0.1%, as maintenance therapy for acne vulgaris: a randomized, controlled, investigator-blind follow-up of a recent combination study","volume":"142","author":"Thiboutot","year":"2006","journal-title":"Arch Dermatol"},{"issue":"2","key":"10.1016\/j.cct.2011.12.005_bb0125","doi-asserted-by":"crossref","first-page":"242","DOI":"10.1016\/j.jaad.2004.10.879","article-title":"Adapalene gel 0.3% for the treatment of acne vulgaris: a multicenter, randomized, double-blind, controlled, phase III trial","volume":"54","author":"Thiboutot","year":"2006","journal-title":"J Am Acad Dermatol"},{"key":"10.1016\/j.cct.2011.12.005_bb0130","series-title":"SF-36 health survey manual and interpretation guide","author":"Ware","year":"1993"},{"issue":"2","key":"10.1016\/j.cct.2011.12.005_bb0135","doi-asserted-by":"crossref","first-page":"191","DOI":"10.1080\/009262300278597","article-title":"The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function","volume":"26","author":"Rosen","year":"2000","journal-title":"J Sex Marital Ther"},{"issue":"6","key":"10.1016\/j.cct.2011.12.005_bb0140","doi-asserted-by":"crossref","first-page":"822","DOI":"10.1016\/S0090-4295(97)00238-0","article-title":"The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction","volume":"49","author":"Rosen","year":"1997","journal-title":"Urology"},{"issue":"8","key":"10.1016\/j.cct.2011.12.005_bb0145","doi-asserted-by":"crossref","first-page":"2084","DOI":"10.1093\/humrep\/der171","article-title":"The fertility quality of life (FertiQoL) tool: development and general psychometric properties","volume":"26","author":"Boivin","year":"2011","journal-title":"Hum Reprod"},{"issue":"2","key":"10.1016\/j.cct.2011.12.005_bb0150","doi-asserted-by":"crossref","first-page":"409","DOI":"10.1016\/j.fertnstert.2011.02.046","article-title":"The Fertility Quality of Life (FertiQoL) tool: development and general psychometric properties","volume":"96","author":"Boivin","year":"2011","journal-title":"Fertil Steril"},{"issue":"6","key":"10.1016\/j.cct.2011.12.005_bb0155","doi-asserted-by":"crossref","first-page":"1976","DOI":"10.1210\/jc.83.6.1976","article-title":"Development of a health-related quality-of-life questionnaire (PCOSQ) for women with polycystic ovary syndrome (PCOS)","volume":"83","author":"Cronin","year":"1998","journal-title":"J Clin Endocrinol Metab"},{"issue":"12","key":"10.1016\/j.cct.2011.12.005_bb0160","doi-asserted-by":"crossref","first-page":"1279","DOI":"10.1016\/j.jclinepi.2003.10.018","article-title":"Health-related quality of life in women with polycystic ovary syndrome, a self-administered questionnaire, was validated","volume":"57","author":"Guyatt","year":"2004","journal-title":"J Clin Epidemiol"},{"issue":"2","key":"10.1016\/j.cct.2011.12.005_bb0165","doi-asserted-by":"crossref","first-page":"517","DOI":"10.1210\/jc.86.2.517","article-title":"Polycystic ovary syndrome is associated with obstructive sleep apnea and daytime sleepiness: role of insulin resistance","volume":"86","author":"Vgontzas","year":"2001","journal-title":"J Clin Endocrinol Metab"},{"issue":"1","key":"10.1016\/j.cct.2011.12.005_bb0170","doi-asserted-by":"crossref","first-page":"36","DOI":"10.1210\/jc.2005-1084","article-title":"Relationships between sleep disordered breathing and glucose metabolism in polycystic ovary syndrome","volume":"91","author":"Tasali","year":"2006","journal-title":"J Clin Endocrinol Metab"},{"issue":"3","key":"10.1016\/j.cct.2011.12.005_bb0175","doi-asserted-by":"crossref","first-page":"735","DOI":"10.1164\/ajrccm.150.3.8087345","article-title":"Assessment of the validity and utility of a sleep-symptom questionnaire","volume":"150","author":"Kump","year":"1994","journal-title":"Am J Respir Crit Care Med"},{"issue":"1","key":"10.1016\/j.cct.2011.12.005_bb0180","doi-asserted-by":"crossref","first-page":"92","DOI":"10.1016\/S0029-7844(00)01083-8","article-title":"Reliability of ovulation tests in infertile women","volume":"97","author":"Guermandi","year":"2001","journal-title":"Obstet Gynecol"},{"issue":"4","key":"10.1016\/j.cct.2011.12.005_bb0185","doi-asserted-by":"crossref","first-page":"963","DOI":"10.2307\/2529876","article-title":"Random-effects models for longitudinal data","volume":"38","author":"Laird","year":"1982","journal-title":"Biometrics"},{"issue":"4","key":"10.1016\/j.cct.2011.12.005_bb0190","doi-asserted-by":"crossref","first-page":"1444","DOI":"10.1016\/j.fertnstert.2009.05.047","article-title":"Intercourse compliance, ovulation, and treatment success in the National Institute of Child Health and Human Development-Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome (PPCOS) Trial","volume":"94","author":"Pagidas","year":"2010","journal-title":"Fertil Steril"},{"key":"10.1016\/j.cct.2011.12.005_bb0195","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.neuroscience.2011.06.024","article-title":"Neuroactive steroids: focus on human brain","volume":"191","author":"Melcangi","year":"2011","journal-title":"Neuroscience"},{"issue":"3","key":"10.1016\/j.cct.2011.12.005_bb0200","doi-asserted-by":"crossref","first-page":"551","DOI":"10.1097\/01.AOG.0000114989.84822.51","article-title":"Perinatal outcomes in singletons following in vitro fertilization: a meta-analysis","volume":"103","author":"Jackson","year":"2004","journal-title":"Obstet Gynecol"},{"issue":"5","key":"10.1016\/j.cct.2011.12.005_bb0205","doi-asserted-by":"crossref","first-page":"1308","DOI":"10.1016\/j.fertnstert.2005.03.086","article-title":"In vitro fertilization is associated with an increase in major birth defects","volume":"84","author":"Olson","year":"2005","journal-title":"Fertil Steril"},{"issue":"4","key":"10.1016\/j.cct.2011.12.005_bb0210","doi-asserted-by":"crossref","first-page":"599","DOI":"10.1086\/382897","article-title":"Epigenetics and assisted reproductive technology: a call for investigation","volume":"74","author":"Niemitz","year":"2004","journal-title":"Am J Hum Genet"},{"issue":"5","key":"10.1016\/j.cct.2011.12.005_bb0215","doi-asserted-by":"crossref","first-page":"1725","DOI":"10.1016\/j.fertnstert.2010.11.068","article-title":"Anastrozole single-dose protocol in women with oligo- or anovulatory infertility: results of a randomized phase II dose\u2013response study","volume":"95","author":"Tredway","year":"2011","journal-title":"Fertil Steril"},{"issue":"5","key":"10.1016\/j.cct.2011.12.005_bb0220","doi-asserted-by":"crossref","first-page":"1720","DOI":"10.1016\/j.fertnstert.2010.12.064","article-title":"Anastrozole vs. clomiphene citrate in infertile women with ovulatory dysfunction: a phase II, randomized, dose-finding study","volume":"95","author":"Tredway","year":"2011","journal-title":"Fertil Steril"},{"issue":"5","key":"10.1016\/j.cct.2011.12.005_bb0225","doi-asserted-by":"crossref","first-page":"1209","DOI":"10.1016\/j.fertnstert.2007.05.010","article-title":"Anastrozole or letrozole for ovulation induction in clomiphene-resistant women with polycystic ovarian syndrome: a prospective randomized trial","volume":"89","author":"Badawy","year":"2008","journal-title":"Fertil Steril"},{"issue":"5","key":"10.1016\/j.cct.2011.12.005_bb0230","doi-asserted-by":"crossref","first-page":"222","DOI":"10.3109\/19396368.2011.604819","article-title":"for the Reproductive Medicine Network. Establishing a biologic specimens repository for reproductive clinical trials: technical aspects","volume":"57","author":"Casson","year":"2011","journal-title":"Syst Biol Reprod Med"},{"issue":"3","key":"10.1016\/j.cct.2011.12.005_bb0235","doi-asserted-by":"crossref","first-page":"853","DOI":"10.1016\/j.fertnstert.2007.08.044","article-title":"Comparison of efficacy of aromatase inhibitor and clomiphene citrate in induction of ovulation in polycystic ovarian syndrome","volume":"92","author":"Begum","year":"2009","journal-title":"Fertil Steril"},{"key":"10.1016\/j.cct.2011.12.005_bb0240","first-page":"244","article-title":"Aromatase inhibition: a novel method of ovulation induction in women with polycystic ovary syndrome","volume":"10","author":"Mitwally","year":"2000","journal-title":"Reprod Technol"}],"container-title":["Contemporary Clinical Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1551714412000237?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1551714412000237?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2018,11,27]],"date-time":"2018-11-27T03:27:23Z","timestamp":1543289243000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1551714412000237"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,5]]},"references-count":48,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2012,5]]}},"alternative-id":["S1551714412000237"],"URL":"https:\/\/doi.org\/10.1016\/j.cct.2011.12.005","relation":{},"ISSN":["1551-7144"],"issn-type":[{"value":"1551-7144","type":"print"}],"subject":[],"published":{"date-parts":[[2012,5]]}}}