Evidence map›Paper›PMID 26401593›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2015

Randomized Controlled Trial of Preconception Interventions in Infertile Women With Polycystic Ovary Syndrome.

Richard S Legro, William C Dodson, Penny M Kris-Etherton, Allen R Kunselman, Christy M Stetter, Nancy I Williams, Carol L Gnatuk, Stephanie J Estes, Jennifer Fleming, Kelly C Allison and 3 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05952882 (Effectiveness of the Combination Liraglutide and Metformin on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With Polycystic Ovarian Syndrome, Obesity and Infertility), which is not on this map. Cited by 91 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing papers in PubMed, 15 pooled it
28.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05952882 phase3unknown statusstarted 2023, after this paper: background citation

Effectiveness of the Combination Liraglutide and Metformin on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With Polycystic Ovarian Syndrome, Obesity and Infertility

Ran2023Enrolled188Registered outcomes60Posted comparisons0ConditionsInfertility, Female, Obesity, Polycystic Ovary SyndromeArmsLiraglutide + metformin, Metformin
PMID 18364705PMID 28681988PMID 19056992PMID 31229399PMID 29703793PMID 19841045PMID 31733195PMID 24362411PMID 31238940PMID 11527911PMID 14688154PMID 17980364other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

91 citing papers in PubMed, 15 syntheses or guidelines pooled it, 235 citations in OpenAlex.

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  10. Lifestyle changes in women with polycystic ovary syndrome.The Cochrane database of systematic reviews · 2019
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  12. Obesity in the Workplace: Impact, Outcomes, and Recommendations.Journal of occupational and environmental medicine · 2018
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31 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Richard S LegroDepartments of Obstetrics and Gynecology (R.S.L., W.C.D., C.L.G., S.J.E.) and Public Health Sciences (R.S.L., A.R.K., C.M.S.), Penn State College of Medicine, Hershey, PA, Departments of Nutritional Sciences (P.M.K., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802; and Departments of Psychiatry (D.B.S., K.C.A.), Surgery (D.B.S.), and Obstetrics and Gynecology (A.D., C.C.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104.
William C DodsonDepartments of Obstetrics and Gynecology (R.S.L., W.C.D., C.L.G., S.J.E.) and Public Health Sciences (R.S.L., A.R.K., C.M.S.), Penn State College of Medicine, Hershey, PA, Departments of Nutritional Sciences (P.M.K., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802; and Departments of Psychiatry (D.B.S., K.C.A.), Surgery (D.B.S.), and Obstetrics and Gynecology (A.D., C.C.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104.
Penny M Kris-EthertonDepartments of Obstetrics and Gynecology (R.S.L., W.C.D., C.L.G., S.J.E.) and Public Health Sciences (R.S.L., A.R.K., C.M.S.), Penn State College of Medicine, Hershey, PA, Departments of Nutritional Sciences (P.M.K., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802; and Departments of Psychiatry (D.B.S., K.C.A.), Surgery (D.B.S.), and Obstetrics and Gynecology (A.D., C.C.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104.
Allen R KunselmanDepartments of Obstetrics and Gynecology (R.S.L., W.C.D., C.L.G., S.J.E.) and Public Health Sciences (R.S.L., A.R.K., C.M.S.), Penn State College of Medicine, Hershey, PA, Departments of Nutritional Sciences (P.M.K., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802; and Departments of Psychiatry (D.B.S., K.C.A.), Surgery (D.B.S.), and Obstetrics and Gynecology (A.D., C.C.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104.
Christy M StetterDepartments of Obstetrics and Gynecology (R.S.L., W.C.D., C.L.G., S.J.E.) and Public Health Sciences (R.S.L., A.R.K., C.M.S.), Penn State College of Medicine, Hershey, PA, Departments of Nutritional Sciences (P.M.K., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802; and Departments of Psychiatry (D.B.S., K.C.A.), Surgery (D.B.S.), and Obstetrics and Gynecology (A.D., C.C.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104.
Nancy I WilliamsDepartments of Obstetrics and Gynecology (R.S.L., W.C.D., C.L.G., S.J.E.) and Public Health Sciences (R.S.L., A.R.K., C.M.S.), Penn State College of Medicine, Hershey, PA, Departments of Nutritional Sciences (P.M.K., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802; and Departments of Psychiatry (D.B.S., K.C.A.), Surgery (D.B.S.), and Obstetrics and Gynecology (A.D., C.C.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104.
Carol L GnatukDepartments of Obstetrics and Gynecology (R.S.L., W.C.D., C.L.G., S.J.E.) and Public Health Sciences (R.S.L., A.R.K., C.M.S.), Penn State College of Medicine, Hershey, PA, Departments of Nutritional Sciences (P.M.K., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802; and Departments of Psychiatry (D.B.S., K.C.A.), Surgery (D.B.S.), and Obstetrics and Gynecology (A.D., C.C.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104.
Stephanie J EstesDepartments of Obstetrics and Gynecology (R.S.L., W.C.D., C.L.G., S.J.E.) and Public Health Sciences (R.S.L., A.R.K., C.M.S.), Penn State College of Medicine, Hershey, PA, Departments of Nutritional Sciences (P.M.K., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802; and Departments of Psychiatry (D.B.S., K.C.A.), Surgery (D.B.S.), and Obstetrics and Gynecology (A.D., C.C.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104.
Jennifer FlemingDepartments of Obstetrics and Gynecology (R.S.L., W.C.D., C.L.G., S.J.E.) and Public Health Sciences (R.S.L., A.R.K., C.M.S.), Penn State College of Medicine, Hershey, PA, Departments of Nutritional Sciences (P.M.K., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802; and Departments of Psychiatry (D.B.S., K.C.A.), Surgery (D.B.S.), and Obstetrics and Gynecology (A.D., C.C.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104.
Kelly C AllisonDepartments of Obstetrics and Gynecology (R.S.L., W.C.D., C.L.G., S.J.E.) and Public Health Sciences (R.S.L., A.R.K., C.M.S.), Penn State College of Medicine, Hershey, PA, Departments of Nutritional Sciences (P.M.K., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802; and Departments of Psychiatry (D.B.S., K.C.A.), Surgery (D.B.S.), and Obstetrics and Gynecology (A.D., C.C.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104.
David B SarwerDepartments of Obstetrics and Gynecology (R.S.L., W.C.D., C.L.G., S.J.E.) and Public Health Sciences (R.S.L., A.R.K., C.M.S.), Penn State College of Medicine, Hershey, PA, Departments of Nutritional Sciences (P.M.K., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802; and Departments of Psychiatry (D.B.S., K.C.A.), Surgery (D.B.S.), and Obstetrics and Gynecology (A.D., C.C.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104.
Christos CoutifarisDepartments of Obstetrics and Gynecology (R.S.L., W.C.D., C.L.G., S.J.E.) and Public Health Sciences (R.S.L., A.R.K., C.M.S.), Penn State College of Medicine, Hershey, PA, Departments of Nutritional Sciences (P.M.K., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802; and Departments of Psychiatry (D.B.S., K.C.A.), Surgery (D.B.S.), and Obstetrics and Gynecology (A.D., C.C.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104.
Anuja DokrasDepartments of Obstetrics and Gynecology (R.S.L., W.C.D., C.L.G., S.J.E.) and Public Health Sciences (R.S.L., A.R.K., C.M.S.), Penn State College of Medicine, Hershey, PA, Departments of Nutritional Sciences (P.M.K., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802; and Departments of Psychiatry (D.B.S., K.C.A.), Surgery (D.B.S.), and Obstetrics and Gynecology (A.D., C.C.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104.
Park University · USPennsylvania State University · USUniversity of Pennsylvania · US

Funding

Penn State Clinical and Translational Science InstituteUL1TR002014 · NCATS · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI KRASCHNEWSKI, JENNIFER L. · 2016 to 2025
$33.7M
Penn State Clinical and Translational Science InstituteUL1TR000127 · NCATS · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI SINOWAY, LAWRENCE I · 2012 to 2015
$17.1M
Testosterone-GnRH Frequency and the Evolution of PCOS in AdolescenceP50HD028934 · NICHD · UNIVERSITY OF VIRGINIA · PI HAISENLEDER, DANIEL J. · 2014 to 2018
$8.6M
Treatment of Hyperandrogenism vs. Insulin Resistance in Infertile PCOS WomenR01HD056510 · NICHD · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI LEGRO, RICHARD S. · 2008 to 2012
$3.1M
MIGRATION AND URBAN FERTILITYR01HD029834 · NICHD · YALE UNIVERSITY · PI GUINNANE, TIMOTHY W · 1995 to 1997
–
NCATS NIH HHS UL1 TR000127NCATS NIH HHS UL1 TR002014NICHD NIH HHS P50 HD028934NICHD NIH HHS R01 HD029834NICHD NIH HHS R01 HD056510NICHD NIH HHS U54 HD29834
6 · The paper itself

Abstract

contextLifestyle modification is recommended in women with polycystic ovary syndrome (PCOS) prior to conception but there are few randomized trials to support its implementation or benefit.

objectiveThis study aimed to determine the relative efficacy of preconception intervention on reproductive and metabolic abnormalities in overweight/obese women with PCOS. DESIGN, SETTING, AND

participantsThis was a randomized controlled trial of preconception and infertility treatment at Academic Health Centers in women with infertility due to PCOS, age 18-40 y and body mass index 27-42 kg/m(2).

interventionWomen were randomly assigned to receive either 16 weeks of 1) continuous oral contraceptive pills (OCPs) (ethinyl estradiol 20 mcg/1 mg norethindrone acetate) ("OCP"); 2) lifestyle modification consisting of caloric restriction with meal replacements, weight loss medication (either sibutramine, or orlistat), and increased physical activity to promote a 7% weight loss ("Lifestyle"); or 3) combined treatment with both OCP and lifestyle modification ("Combined"). After preconception intervention, women underwent standardized ovulation induction with clomiphene citrate and timed intercourse for four cycles. Pregnancies were followed with trimester visits until delivery.

main outcome measuresWeight, ovulation, and live birth were measured.

resultsWe consented 216 and randomly assigned 149 women (Lifestyle: n = 50; OCP: n = 49; Combined: n = 50). We achieved significant weight loss with both Lifestyle (mean weight loss, -6.2%; 95% confidence interval (CI), -7.4--5.0; and Combined (mean weight loss, -6.4%; 95% CI, -7.6--5.2) compared with baseline and OCP (both P < .001). There was a significant increase in the prevalence of metabolic syndrome at the end of preconception treatment compared with baseline within OCP (odds ratio [OR, 2.47; 95% CI, 1.42-4.27) whereas no change in metabolic syndrome was detected in the Lifestyle (OR, 1.18; 95% CI, 0.63-2.19) or Combined (OR, 0.72; 95% CI, 0.44-1.17) groups. Cumulative ovulation rates were superior after weight loss: OCP, 46%; Lifestyle, 60%; and Combined, 67% (P < .05). Live birth rates were OCP, 12%; Lifestyle, 26%; and Combined, 24% (P = .13).

conclusionsA preconception weight loss intervention eliminates the adverse metabolic oral contraceptive effects and, compared with oral contraceptive pretreatment, leads to higher ovulation rates.

Indexed as

Ovulation InductionPreconception CareAdultAnti-Obesity AgentsBehavior TherapyBirth RateBody Mass IndexClomipheneCombined Modality TherapyDiet, ReducingDrug ResistanceFemaleFertility Agents, FemaleHumansInfertility, FemaleLife StyleAnti-Obesity AgentsClomipheneFertility Agents, Female

Identifiers

PMID26401593
PMCPMC4702450
OpenAlexW2142157239

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.