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Title page
Contents
Preface 4
Acknowledgments 5
Evidence Summary 12
Introduction 44
Background 44
Condition 44
Treatment Strategies 44
Complexity of Decisionmaking for Treatments of Infertility 45
Limitations of the Evidence Base 46
Scope and Key Questions 46
Scope of the Review 46
Key Questions 47
Organization of This Report 49
Methods 50
Topic Refinement and Review Protocol 50
Literature Search Strategy 50
Search Strategy 50
Inclusion and Exclusion Criteria 51
Study Selection 54
Data Extraction 55
Quality (Risk of Bias) Assessment of Individual Studies 55
Data Synthesis 56
Strength of the Body of Evidence 57
Applicability 58
Peer Review and Public Commentary 58
Results 59
Introduction 59
Results of Literature Searches 59
Description of Included Studies 62
Key Question 1. PCOS 62
Description of Studies Included for KQ 1 (PCOS) 62
Key Points for PCOS 63
Detailed Synthesis by Treatment for PCOS 63
Subgroups of Interest for PCOS 78
Strength of Evidence for PCOS 78
Key Question 2. Endometriosis 83
Description of Included Studies for KQ 2 (Endometriosis) 83
Key Points for Endometriosis 84
Detailed Synthesis by Treatment for Endometriosis 84
Subpopulations of Interest for Endometriosis 85
Strength of Evidence for Endometriosis 86
Key Question 3. Unexplained Infertility 87
Description of Included Studies for KQ 3 (Unexplained Infertility) 87
Key Points for Unexplained Infertility 88
Detailed Synthesis by Treatment for Unexplained Infertility 88
Strength of Evidence for Unexplained Infertility 101
Key Question 4. Tubal and Peritoneal Factor Infertility 104
Description of Included Studies for KQ 4 (Tubal and Peritoneal Factor Infertility) 104
Key Points for Tubal or Peritoneal Factor Infertility 105
Detailed Synthesis by Treatment for Tubal or Peritoneal Factor Infertility 105
Strength of Evidence for Tubal and Peritoneal Factor Infertility 106
Key Question 5. Male Factor Infertility 107
Description of Included Studies for KQ 5 (Male Factor) 107
Key Points for Male Factor Infertility 108
Detailed Synthesis by Treatment for Male Factor Infertility 108
Strength of Evidence for Male Factor Infertility 112
Key Question 6. Donors in Infertility 114
Description of Included Studies for KQ 6 (Donors) 115
Key Points for Donors 115
Detailed Synthesis for Oocyte Donors 115
Strength of Evidence for Donors 116
Key Findings Across All Key Questions 117
Key Points for Any Infertility Diagnosis 117
Subgroups of Interest (With Any Infertility Diagnosis) 119
Strength of Evidence (With Any Infertility Diagnosis) 120
Publication Bias 121
Discussion 122
Key Findings and Strength of Evidence 122
Findings in Relation to What is Already Known 122
Applicability 134
Implications for Clinical and Policy Decisionmaking 136
Limitations of the Systematic Review Process 137
Research Recommendations 138
Conclusion 140
Acronyms and Abbreviations 141
References 143
Table A. Summary of strength of evidence for major outcomes-KQ 1 (PCOS) 18
Table B. Summary of strength of evidence for major outcomes-KQ 2 (endometriosis) 20
Table C. Summary of strength of evidence for major outcomes-KQ 3 (unexplained infertility) 21
Table D. Summary of strength of evidence for major outcomes-KQ 4 (tubal and peritoneal factor infertility) 23
Table E. Summary of strength of evidence for major outcomes-KQ 5 (male factor infertility) 23
Table F. Summary of strength of evidence for major outcomes-KQ 6 (donors in infertility) 25
Table G. Summary of strength of evidence for major outcomes-all key questions 25
Table 1/Table 7. Inclusion and exclusion criteria 51
Table 2/Table 8. Definitions of overall quality ratings 55
Table 3/Table 9. Key to primary and companion articles 59
Table 4/Table 10. Outcomes for comparisons of oral agents alone in women with PCOS 65
Table 5/Table 11. Outcomes for oral agents alone vs. oral agents with IUI in women with PCOS 68
Table 6/Table 12. Outcomes for oral agents alone vs. surgical management in women with PCOS 69
Table 7/Table 13. Outcomes for oral agents vs. gonadotropins in women with PCOS 71
Table 8/Table 14. Outcomes for surgical management vs. gonadotropins in women with PCOS 72
Table 9/Table 15. Outcomes for gonadotropins with IUI in women with PCOS 73
Table 10/Table 16. Outcomes for comparisons of IVF treatments in women with PCOS 75
Table 11/Table 17. Outcomes for adjuncts to IVF in women with PCOS 77
Table 12/Table 18. Outcomes for comparisons of ICSI treatment in women with PCOS 77
Table 13/Table 19. Strength of evidence for major outcomes-KQ 1 (PCOS) 79
Table 14/Table 20. Strength of evidence for major outcomes-KQ 2 (Endometriosis) 86
Table 15/Table 21. Outcomes for comparisons of oral agents without IUI in women with unexplained infertility 89
Table 16/Table 22. Outcomes for comparisons of oral agents vs. unstimulated IUI vs. expectant management in women with unexplained infertility 90
Table 17/Table 23. Outcomes for comparisons of oral agents with IUI in women with unexplained infertility 92
Table 18/Table 24. Outcomes for comparisons of different treatment strategies for controlled ovarian hyperstimulation with gonadotropins and IUI in women with unexplained infertility 94
Table 19/Table 25. Outcomes for comparisons of immediate IVF versus other treatments prior to IVF in women with unexplained infertility 95
Table 20/Table 26. Strength of evidence for major outcomes-KQ 3 (unexplained infertility) 101
Table 21/Table 27. Strength of evidence for major outcomes-KQ 4 (tubal and peritoneal factor infertility) 106
Table 22/Table 28. Outcomes for comparisons of IVF in couples with male infertility 109
Table 23/Table 29. Strength of evidence for major outcomes-KQ 5 (male factor infertility) 112
Table 24/Table 30. Strength of evidence for major outcomes-KQ 6 (donor) 117
Table 25/Table 31. Cancer Risk for Ever Use of Clomiphene Citrate 118
Table 26/Table 32. Cancer Risk for Ever Use of Gonadotropins 118
Table 27/Table 33. Birth rates by number of embryos transferred 119
Table 28/Table 34. Strength of evidence for major outcomes-across all key questions 120
Table 29/Table 35. Report findings and major guidelines/recommendations-KQ 1 PCOS 125
Table 30/Table 36. Report findings and major guidelines/recommendations-KQ 2 Endometriosis 127
Table 31/Table 37. Report findings and major guidelines/recommendations-KQ 3 Unexplained Infertility 128
Table 32/Table 38. Report findings and major guidelines/recommendations-KQ 4 Tubal and Peritoneal Factor Infertility 129
Table 33/Table 39. Report findings and major guidelines/recommendations-KQ 5 Male Factor Infertility 130
Table 34/Table 40. Report findings and major guidelines/recommendations-KQ 6 Donors 131
Table 35/Table 41. Report findings and major guidelines/recommendations-all KQs: long-term outcomes of treatments 133
Table 36/Table 42. Potential issues with applicability of included studies 134
Figure A. Analytic framework 15
Figure 1. Analytic framework 48
Figure 2. Literature flow diagram 61
Figure 3. Effect of ICSI vs. IMSI on live birth 110
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