Evidence map›Paper›PMID 24156957›Full record

Trial reportFertility and sterility2014

The Pregnancy in Polycystic Ovary Syndrome II study: baseline characteristics and effects of obesity from a multicenter randomized clinical trial.

Richard S Legro, Robert G Brzyski, Michael P Diamond, Christos Coutifaris, William D Schlaff, Ruben Alvero, Peter Casson, Gregory M Christman, Hao Huang, Qingshang Yan and 14 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Fertility and sterility, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00719186 (A 20 Week Double-Blind Randomized Trial of Clomiphene Citrate and Letrozole for the Treatment of Infertility in Women With Polycystic Ovary Syndrome), which is not on this map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
6.4field-weighted citation impact, top 4% 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.

NCT00719186 phase3completednot on this map

A 20 Week Double-Blind Randomized Trial of Clomiphene Citrate and Letrozole for the Treatment of Infertility in Women With Polycystic Ovary Syndrome

TypeinterventionalSponsorYale UniversityRan2009 to 2013Enrolled750ConditionsPregnancy, Polycystic Ovary SyndromeArmsClomiphene citrate, Letrozole
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 2 syntheses or guidelines pooled it, 69 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Sleep Habits of Women With Infertility.The Journal of clinical endocrinology and metabolism · 2021
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  11. Randomized Controlled Trial of Preconception Interventions in Infertile Women With Polycystic Ovary Syndrome.The Journal of clinical endocrinology and metabolism · 2015 · on this map
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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

24 authors at 15 institutions in 1 country.

Richard S LegroDepartment of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania. Electronic address: RSL1@PSU.EDU.
Robert G BrzyskiDepartment of Obstetrics and Gynecology, University of Texas Health Science Center at San Antonio, Texas.
Michael P DiamondDepartment of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.
Christos CoutifarisDepartment of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
William D SchlaffDepartment of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.
Ruben AlveroDepartment of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.
Peter CassonDepartment of Obstetrics and Gynecology, University of Vermont, Burlington, Vermont.
Gregory M ChristmanDepartment of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.
Hao HuangDepartment of Biostatistics, Yale University School of Medicine, New Haven, Connecticut.
Qingshang YanDepartment of Biostatistics, Yale University School of Medicine, New Haven, Connecticut.
Daniel J HaisenlederLigand Core Laboratory University of Virginia Center for Research in Reproduction, Charlottesville, Virginia.
Kurt T BarnhartDepartment of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
G Wright BatesDepartment of Obstetrics and Gynecology, University of Alabama, Birmingham, Alabama.
Rebecca UsadiDepartment of Obstetrics and Gynecology, Carolinas HealthCare Center for Reproductive Medicine, Charlotte, North Carolina.
Richard LucidiDepartment of Obstetrics and Gynecology, Virginia Commonwealth University, Richmond, Virginia.
Valerie BakerDepartment of Obstetrics and Gynecology, Stanford Hospital, Palo Alto, California.
J C TrussellUrology, SUNY Upstate Medical University, Syracuse, New York.
Stephen A KrawetzDepartment of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.
Peter SnyderDepartment of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
Dana OhlDepartment of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.
Nanette SantoroDepartment of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.
Esther EisenbergFertility and Infertility Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Rockville, Maryland.
Heping ZhangDepartment of Biostatistics, Yale University School of Medicine, New Haven, Connecticut.
National Institute of Child Health and Human Development Reproductive Medicine Network
University of Colorado Denver · USUniversity of Pennsylvania · USYale University · USUniversity of Michigan–Ann Arbor · USWayne State University · USCarolinas Healthcare System · USNational Institutes of Health · USPennsylvania State University · USStanford University · USSUNY Upstate Medical University · USThe University of Texas Health Science Center at San Antonio · USUniversity of Alabama at Birmingham · USUniversity of Vermont · USUniversity of Virginia · USVirginia Commonwealth University · US

Funding

Data Coordination Center for the RMNU10HD055925 · NICHD · YALE UNIVERSITY · PI ZHANG, HEPING · 2007 to 2019
$39.2M
WRITING AND THE DAILY EXPERIENCE OF ILLNESSM01RR010732 · NCRR · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI DONG, CHENG · 1995 to 2009
$29.8M
Testosterone-GnRH Frequency and the Evolution of PCOS in AdolescenceP50HD028934 · NICHD · UNIVERSITY OF VIRGINIA · PI HAISENLEDER, DANIEL J. · 2014 to 2018
$8.6M
COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORKU10HD027049 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI COUTIFARIS, CHRISTOS · 1990 to 2017
$5.2M
GHSU/WSU Cooperative Reproductive Medicine NetworkU10HD039005 · NICHD · WAYNE STATE UNIVERSITY · PI DIAMOND, MICHAEL PETER · 2000 to 2017
$5.2M
COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORKU10HD038992 · NICHD · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI LEGRO, RICHARD S. · 2000 to 2017
$5.0M
COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORKU10HD038998 · NICHD · UNIVERSITY OF COLORADO DENVER · PI POLOTSKY, ALEX JOEL · 2000 to 2015
$2.6M
Cooperative Multicenter Reproductive Medicine Network (U10)U10HD055936 · NICHD · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SMITH, YOLANDA R · 2007 to 2014
$2.1M
The Utility of Empiric Medical Treatment of Infertile Oligo-asthenospermic MenU10HD055944 · NICHD · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI MCGEE, ELIZABETH A · 2007 to 2013
$2.1M
Letrozole Therapy for IVF/ET: Effects on Multiple Pregnancy and Treatment BurdenU10HD055942 · NICHD · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI ROBINSON, RANDAL D. · 2007 to 2015
$1.7M
COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORKU10HD033172 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI BLACKWELL, RICHARD · 1995 to 2004
$1.1M
GCRC RELOCATION AND EXPANSION PROJECTC06RR016499 · NCRR · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI KIRCH, DARRELL G · 2001 to 2001
$707k
NCRR NIH HHS C06 RR016499NCRR NIH HHS M01 RR010732NCRR NIH HHS MO1RR10732NICHD NIH HHS P50 HD028934NICHD NIH HHS R01 HD029834NICHD NIH HHS U10 HD027049NICHD NIH HHS U10 HD033172NICHD NIH HHS U10 HD038992NICHD NIH HHS U10 HD038998NICHD NIH HHS U10 HD039005NICHD NIH HHS U10 HD055925NICHD NIH HHS U10HD055925NICHD NIH HHS U10 HD055936NICHD NIH HHS U10 HD055942NICHD NIH HHS U10HD055942NICHD NIH HHS U10 HD055944NICHD NIH HHS U10 HD27049NICHD NIH HHS U10 HD33172NICHD NIH HHS U10 HD38992NICHD NIH HHS U10 HD38998NICHD NIH HHS U10 HD39005NICHD NIH HHS U54-HD29834
6 · The paper itself

Abstract

objectiveTo summarize baseline characteristics from a large multicenter infertility clinical trial.

designCross-sectional baseline data from a double-blind randomized trial of two treatment regimens (letrozole vs. clomiphene).

settingAcademic Health Centers throughout the United States. PATIENT(S): Seven hundred fifty women with polycystic ovary syndrome (PCOS) and their male partners took part in the study. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Historic, biometric, biochemical, and questionnaire parameters. RESULT(S): Females averaged 30 years and were obese (body mass index [BMI] 35) with ∼20% from a racial/ethnic minority. Most (87%) were hirsute and nulligravid (63%). Most of the women had an elevated antral follicle count and enlarged ovarian volume on ultrasound. Women had elevated mean circulating androgens, LH-to-FSH ratio (∼2), and antimüllerian hormone levels (8.0 ng/mL). In addition, women had evidence for metabolic dysfunction with elevated mean fasting insulin and dyslipidemia. Increasing obesity was associated with decreased LH-to-FSH levels, antimüllerian hormone levels, and antral follicle counts but increasing cardiovascular risk factors, including prevalence of the metabolic syndrome. Men were obese (BMI 30) and had normal mean semen parameters. CONCLUSION(S): The treatment groups were well matched at baseline. Obesity exacerbates select female reproductive and most metabolic parameters. We have also established a database and sample repository that will eventually be accessible to investigators. CLINICAL TRIAL REGISTRATION NUMBER: NCT00719186.

Indexed as

PregnancyAdultDouble-Blind MethodFemaleFertility Agents, FemaleHumansMaleObesityPolycystic Ovary SyndromeYoung AdultFertility Agents, FemalehirsutisminfertilityInsulin resistancemetabolic syndromeovulation induction

Identifiers

PMID24156957
PMCPMC3899700
OpenAlexW2142748120

What OpenQuestion holds

Textmetadata
LicenceTDM
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.