title: Fertility-related quality of life from two RCT cohorts with infertility: unexplained infertility and polycystic ovary syndrome.
abstract: Does fertility-related quality of life (FertiQOL) differ by infertility diagnosis between women with polycystic ovary syndrome (PCOS) and their partners, compared with couples with unexplained infertility (UI)?
  
  
  
  Women with PCOS report lower QOL than those with UI, whereas males with UI report lower QOL than males with PCOS partners.
  
  
  
  The fertility-specific QOL survey, FertiQOL, has been used to examine fertility-related QOL in a number of worldwide cohorts. Few data have addressed fertility-related QOL as a function of infertility diagnosis. Overall, men report better QOL than women with infertility, and there is variation in FertiQOL scores across different samples from different countries.
  
  
  
  This was a prospective, cohort study derived from two concurrent, randomized clinical trials, and designed to examine QOL in infertile females with PCOS and UI at the time of enrollment compared with each other and their male partners; to compare concordance FertiQOL scores in this study across other worldwide cohorts; and to determine if baseline FertiQOL was associated with pregnancy outcome.
  
  
  
  Women with PCOS and their partners (n = 733 and n = 641, respectively), and couples with UI (n = 865 women and 849 men) completed a validated fertility-specific QOL survey (FertiQOL) at the time of the study screening visit. PCOS women were randomized to either clomiphene citrate or letrozole treatment; couples with UI were randomized to clomiphene citrate, letrozole or gonadotrophin plus IUI. FertiQOL results were compiled by diagnosis (PCOS or UI) and compared by diagnosis and sex using Wilcoxon Rank-Sum testing. Relationships between baseline FertiQOL and pregnancy outcomes were examined using logistic regression. Multivariable models were performed to assess the association between FertiQOL scores and key participant characteristics.
  
  
  
  Women with PCOS had lower total FertiQOL scores (72.3 ± 14.8) than those with UI (77.1 ± 12.8; P < 0.001); this was true for each domain (except Relational). These differences were largely explained by variation in BMI, hirsutism, household income and age. Women had lower overall FertiQOL scores than their male partners. Males with PCOS partners had higher scores than males with UI (84.9 ± 10.2 versus 83.3 ± 10.8; P = 0.003). Scores were not consistently associated with conception or pregnancy outcome.
  
  
  
  The use of multiple tests of association may have resulted in spurious statistically significant findings. Inherent sociodemographic differences between women with PCOS and those with UI largely account for the lower QOL in women with PCOS. Our study was unable to assess if changes in QOL affected pregnancy outcome as FertiQOL data were collected prior to treatment. Finally, the participants for both studies represent their local communities, but are not a population-based sample and thus firm conclusions about how representative these couples are to the general population must be made with caution.
  
  
  
  Women with PCOS with elevated BMI and hirsutism scores and with lower socioeconomic status may require more, targeted psychosocial support than those with other diagnoses. Possible attribution of infertility to the male partner appears to result in a lower QOL. There appears to be substantial national variation in FertiQOL scores, with US-based cohorts reporting overall higher QOL.
  
  
  
  This work was supported by National Institutes of Health (NIH)/Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Grants U10 HD39005 (to M.D.), U10 HD38992 (to R.S.L.), (to C.C.), U10 HD38998 (to R.A.), U10 HD055942 (to R.D.R.), HD055944 (to P.C.), U10 HD055936 (to G.C.), U10HD055925 (to H.Z.); and U10 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). Most importantly, this research was made possible by the funding by American Recovery and Reinvestment Act. N.S., E.E., J.C.T., C.G., H.H., R.A., P.C., G.C., C.C., M.D., S.J., W.D.S. and H.Z. report no conflicts of interests/disclosures. L.B.C. reports research support from Ferring Pharmaceuticals and Roche Diagnostics; R.S.L. reports receipt of consulting fees from AstraZeneca, Euroscreen, Sprout Pharmaceuticals, Taken, Kindex, Clarus and Bayer, Inc., and research support from AstraZeneca and Ferring Pharmaceuticals. R.D.R. reports research support from AbbVie.
  
  
  
  Pregnancy in Polycystic Ovary Syndrome II (PPCOS II), NCT00719186; Assessment of Multiple Intrauterine Gestations in Ovulation Stimulation (AMIGOS) NCT01044862, clinicaltrials.gov.
  
  
  
  PPCOS II 17 July 2008; AMIGOS 7 January 2010.
  
  
  
  PPCOS II 19 February 2009; AMIGOS 2 August 2010.
authors.affiliation: Department of Obstetrics and Gynecology, University of Colorado School of Medicine, 12631 E 17th Avenue AO1 Room 4010, Aurora, CO 80045, USA nanette.santoro@ucdenver.edu.
authors.forename: Nanette
authors.initials: N
authors.lastname: Santoro
authors.affiliation: Fertility & Infertility Branch, NICHD, NIH, Bethesda, MD 20892, USA.
authors.forename: Esther
authors.initials: E
authors.lastname: Eisenberg
authors.affiliation: Department of Urology, State University of New York Upstate Medical University, 750 E Adams St, Syracuse, NY 13210, USA.
authors.forename: J C
authors.initials: JC
authors.lastname: Trussell
authors.affiliation: Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, PO Box 26901, WP 2410 Oklahoma City, OK 73126, USA.
authors.forename: LaTasha B
authors.initials: LB
authors.lastname: Craig
authors.affiliation: Department of Obstetrics and Gynecology, University of Pennsylvania Penn Fertility Center, 3701 Market Street, Philadelphia, PA 19104, USA.
authors.forename: Clarisa
authors.initials: C
authors.lastname: Gracia
authors.affiliation: Collaborative Center for Statistics in Science, Yale School of Public Health, 60 College Street, New Haven, CT 06520-8034, USA.
authors.forename: Hao
authors.initials: H
authors.lastname: Huang
authors.affiliation: Department of Obstetrics and Gynecology, University of Colorado School of Medicine, 12631 E 17th Avenue AO1 Room 4010, Aurora, CO 80045, USA Present address: Department of Obstetrics and Gynecology, Warren Alpert Medical School, Brown University, Providence, RI 02903, USA.
authors.forename: Ruben
authors.initials: R
authors.lastname: Alvero
authors.affiliation: Present address: Northeastern Reproductive Medicine, 105 West View Rd. Suite 305, Colchester, VT 05446, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Casson
authors.affiliation: Present address: Department of Obstetrics and Gynecology, University of Florida College of Medicine, 1600 SW Archer Road, Gainesville, FL 32611-0294, USA.
authors.forename: Gregory
authors.initials: G
authors.lastname: Christman
authors.affiliation: Department of Obstetrics and Gynecology, University of Pennsylvania Penn Fertility Center, 3701 Market Street, Philadelphia, PA 19104, USA.
authors.forename: Christos
authors.initials: C
authors.lastname: Coutifaris
authors.affiliation: Present address: Georgia Regents University/Medical College of Georgia, 1120 15th Street, BA-7300, Augusta, GA 30912-3300, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Diamond
authors.affiliation: Collaborative Center for Statistics in Science, Yale School of Public Health, 60 College Street, New Haven, CT 06520-8034, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Jin
authors.affiliation: Penn State College of Medicine, 500 University Drive, Hersey, PA 17033, USA.
authors.forename: Richard S
authors.initials: RS
authors.lastname: Legro
authors.affiliation: University of Texas at San Antonio Health Sciences Center, 8300 Floyd Curl Drive, San Antonio, TX 78229, USA.
authors.forename: Randal D
authors.initials: RD
authors.lastname: Robinson
authors.affiliation: Present address: Department of Obstetrics and Gynecology, Thomas Jefferson University, 834 Chestnut Street, Suite 400, Philadelphia, PA 19107, USA.
authors.forename: William D
authors.initials: WD
authors.lastname: Schlaff
authors.affiliation: Collaborative Center for Statistics in Science, Yale School of Public Health, 60 College Street, New Haven, CT 06520-8034, USA.
authors.forename: Heping
authors.initials: H
authors.lastname: Zhang
mesh_terms: D000328:Adult; D005260:Female; D005298:Fertility; D006801:Humans; D007247:Infertility, Female / Q000523:psychology*; D008297:Male; D011085:Polycystic Ovary Syndrome / Q000523:psychology*; D011247:Pregnancy; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology*
keywords: FertiQOL; infertility; polycystic ovary syndrome; quality of life; unexplained infertility