Literature DB >> 21435640

Incomplete and inconsistent reporting of maternal and fetal outcomes in infertility treatment trials.

Lisa Dapuzzo1, Faith E Seitz, William C Dodson, Christina Stetter, Allen R Kunselman, Richard S Legro.   

Abstract

Pregnancy outcomes and adverse outcomes in infertility trials are reported to varying extents; for example, 35% of clinical trials reported no information on pregnancy loss, only 43% reported adverse events during the preconception treatment period, and only 7% reported any serious adverse events. Incomplete reporting limits the value of these studies in counseling patients on the risk-benefit ratio of treatment to themselves and their infants.
Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

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Year:  2011        PMID: 21435640      PMCID: PMC3124604          DOI: 10.1016/j.fertnstert.2011.02.040

Source DB:  PubMed          Journal:  Fertil Steril        ISSN: 0015-0282            Impact factor:   7.329


  16 in total

1.  No more surrogate end-points in randomised trials: the PCOSMIC trial protocol for women with polycystic ovary syndrome using metformin for infertility with clomiphene.

Authors:  Neil Philip Johnson
Journal:  Aust N Z J Obstet Gynaecol       Date:  2006-04       Impact factor: 2.100

Review 2.  Evidence of improving quality of reporting of randomized controlled trials in subfertility.

Authors:  Sofia Dias; Roseanne McNamee; Andy Vail
Journal:  Hum Reprod       Date:  2006-06-22       Impact factor: 6.918

3.  Prospective, randomized trial comparing cetrorelix acetate and ganirelix acetate in a programmed, flexible protocol for premature luteinizing hormone surge prevention in assisted reproductive technologies.

Authors:  John Wilcox; Daniel Potter; Marva Moore; Lee Ferrande; Eduardo Kelly
Journal:  Fertil Steril       Date:  2005-07       Impact factor: 7.329

4.  Efficacy and tolerability of vaginal progesterone capsules (Utrogest 200) compared with progesterone gel (Crinone 8%) for luteal phase support during assisted reproduction.

Authors:  Jürgen Kleinstein
Journal:  Fertil Steril       Date:  2005-06       Impact factor: 7.329

5.  Congenital malformations among 911 newborns conceived after infertility treatment with letrozole or clomiphene citrate.

Authors:  Togas Tulandi; James Martin; Raedah Al-Fadhli; Nadia Kabli; Rachel Forman; Jason Hitkari; Clifford Librach; Ellen Greenblatt; Robert F Casper
Journal:  Fertil Steril       Date:  2006-05-02       Impact factor: 7.329

Review 6.  Surrogate end-points or primary outcomes in clinical trials in women with polycystic ovary syndrome?

Authors:  Richard S Legro; Evan Myers
Journal:  Hum Reprod       Date:  2004-06-10       Impact factor: 6.918

7.  Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome.

Authors:  Richard S Legro; Huiman X Barnhart; William D Schlaff; Bruce R Carr; Michael P Diamond; Sandra A Carson; Michael P Steinkampf; Christos Coutifaris; Peter G McGovern; Nicholas A Cataldo; Gabriella G Gosman; John E Nestler; Linda C Giudice; Phyllis C Leppert; Evan R Myers
Journal:  N Engl J Med       Date:  2007-02-08       Impact factor: 91.245

8.  Randomized controlled trial comparing laparoscopic ovarian diathermy with clomiphene citrate as a first-line method of ovulation induction in women with polycystic ovary syndrome.

Authors:  S A Amer; T C Li; M Metwally; M Emarh; W L Ledger
Journal:  Hum Reprod       Date:  2008-09-14       Impact factor: 6.918

9.  Evaluation of mixed protocols with Bravelle (human-derived FSH) and Repronex (hMG) to assess clinical efficacy (EMBRACE) in women undergoing in vitro fertilization.

Authors:  William R Keye; Richard P Marrs; Jerome H Check; Vicki Schnell; Mark Surrey; Dennis C Marshall
Journal:  Fertil Steril       Date:  2004-08       Impact factor: 7.329

10.  Recombinant human leukemia inhibitory factor does not improve implantation and pregnancy outcomes after assisted reproductive techniques in women with recurrent unexplained implantation failure.

Authors:  Peter R Brinsden; Veronica Alam; Beatrice de Moustier; Patrick Engrand
Journal:  Fertil Steril       Date:  2008-08-16       Impact factor: 7.329

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  8 in total

Review 1.  Core domain and outcome measurement sets for shoulder pain trials are needed: systematic review of physical therapy trials.

Authors:  Matthew J Page; Joanne E McKenzie; Sally E Green; Dorcas E Beaton; Nitin B Jain; Mario Lenza; Arianne P Verhagen; Stephen Surace; Jessica Deitch; Rachelle Buchbinder
Journal:  J Clin Epidemiol       Date:  2015-06-16       Impact factor: 6.437

Review 2.  Live birth is the correct outcome for clinical trials evaluating therapy for the infertile couple.

Authors:  Kurt T Barnhart
Journal:  Fertil Steril       Date:  2014-05       Impact factor: 7.329

3.  Improving the reporting of clinical trials of infertility treatments (IMPRINT): modifying the CONSORT statement†‡.

Authors:  Richard S Legro; Xiaoke Wu; Kurt T Barnhart; Cynthia Farquhar; Bart C J M Fauser; Ben Mol
Journal:  Hum Reprod       Date:  2014-09-12       Impact factor: 6.918

Review 4.  No common denominator: a review of outcome measures in IVF RCTs.

Authors:  Jack Wilkinson; Stephen A Roberts; Marian Showell; Daniel R Brison; Andy Vail
Journal:  Hum Reprod       Date:  2016-09-22       Impact factor: 6.918

Review 5.  A protocol developing, disseminating and implementing a core outcome set for infertility.

Authors:  J M N Duffy; S Bhattacharya; C Curtis; J L H Evers; R G Farquharson; S Franik; Y Khalaf; R S Legro; S Lensen; B W Mol; C Niederberger; E H Y Ng; S Repping; A Strandell; H L Torrance; A Vail; M van Wely; N L Vuong; A Y Wang; R Wang; J Wilkinson; M A Youssef; C M Farquhar
Journal:  Hum Reprod Open       Date:  2018-06-15

6.  Developing a core outcome set for future infertility research: an international consensus development study†  ‡.

Authors:  J M N Duffy; H AlAhwany; S Bhattacharya; B Collura; C Curtis; J L H Evers; R G Farquharson; S Franik; L C Giudice; Y Khalaf; J M L Knijnenburg; B Leeners; R S Legro; S Lensen; J C Vazquez-Niebla; D Mavrelos; B W J Mol; C Niederberger; E H Y Ng; A S Otter; L Puscasiu; S Rautakallio-Hokkanen; S Repping; I Sarris; J L Simpson; A Strandell; C Strawbridge; H L Torrance; A Vail; M van Wely; M A Vercoe; N L Vuong; A Y Wang; R Wang; J Wilkinson; M A Youssef; C M Farquhar
Journal:  Hum Reprod       Date:  2020-12-01       Impact factor: 6.918

7.  Recombinant human luteinizing hormone co-treatment in ovarian stimulation for assisted reproductive technology in women of advanced reproductive age: a systematic review and meta-analysis of randomized controlled trials.

Authors:  Alessandro Conforti; Sandro C Esteves; Peter Humaidan; Salvatore Longobardi; Thomas D'Hooghe; Raoul Orvieto; Alberto Vaiarelli; Danilo Cimadomo; Laura Rienzi; Filippo Maria Ubaldi; Fulvio Zullo; Carlo Alviggi
Journal:  Reprod Biol Endocrinol       Date:  2021-06-21       Impact factor: 5.211

8.  Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews.

Authors:  April V P Clyburne-Sherin; Pravheen Thurairajah; Mufiza Z Kapadia; Margaret Sampson; Winnie W Y Chan; Martin Offringa
Journal:  Trials       Date:  2015-09-18       Impact factor: 2.279

  8 in total

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