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Effect of Acupuncture and Clomiphene in Chinese Women with Polycystic Ovary Syndrome

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Effect of Acupuncture and Clomiphene in Chinese Women with Polycystic Ovary Syndrome NATIONAL CLINICAL TRIAL BASE OF CHINESE MEDICINE 《国家中医临床研究基地》妇科慢病项目 Protocol Final Version Effect of Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women with Polycystic Ovary Syndrome: a Randomized Controlled Trial （NCT01573858，ChiCTR-TRC-12002081） Funded by State Administration of Traditional Chinese Medicine January 15, 2013 Downloaded From: https://jamanetwork.com/ on 09/30/2021 PCOSAct Protocol 8.1 CONTENTS 1. Committee composition ...................................................................................................... 4 1.1 Protocol committee .................................................................................................... 4 1.2 Steering Committee ................................................................................................... 4 1.3 Data Coordination Committee .................................................................................. 7 1.4 Publication Committee .............................................................................................. 7 2. Background .......................................................................................................................... 8 3. Objectives ............................................................................................................................ 11 4. Study procedures ............................................................................................................... 12 4.1 Pre-screening ............................................................................................................. 12 4.2 Screening Visit (Visit 1: physician) ............................................................................ 12 4.3 Baseline Visit ............................................................................................................. 12 4.4 Weekly acupuncture Visit: ....................................................................................... 13 4.5 Weekly Serum Progesterone Level and Pregnancy Test ........................................ 13 4.6 Pregnancy Visits (only with conception) ................................................................. 13 4.7 End of Treatment Visit .............................................................................................. 13 5. Study design ....................................................................................................................... 14 6. Subject selection and exclusion ........................................................................................ 14 7. Inclusion criteria ................................................................................................................. 14 8. Exclusion criteria ................................................................................................................ 14 9. Recruitment and Strategy ................................................................................................. 16 9.1 Hospital/Local Health Care Referrals ....................................................................... 16 9.2 Local Publicity Office ................................................................................................ 16 9.3 Local Advertisements ............................................................................................... 16 10. Prescreening ..................................................................................................................... 17 11. Screening Visit .................................................................................................................... 17 12. Physical Examination ......................................................................................................... 17 13. Transvaginal Ultrasound Examination and menstrual cyclicity ...................................... 18 14. Laboratory Examination ................................................................................................... 19 The Central Laboratory: Heilongjiang University of Chinese Medicine Laboratory .... 19 15. Quality of Life Measures (QOL) ....................................................................................... 20 16. Exclusion of Other Infertility Factors .............................................................................. 20 17. Preconception Counseling ................................................................................................ 21 18. Screen Failures .................................................................................................................. 22 19. Counseling about Menstrual and Intercourse Diaries ..................................................... 22 20. Adjuvant Therapy ............................................................................................................. 22 21. Progestin Withdrawal ....................................................................................................... 22 22. Study Specific Procedures/Visits ...................................................................................... 23 22.1 Screening Visit: ........................................................................................................ 23 22.2 Baseline Visit: ......................................................................................................... 24 22.3 Weekly acupuncture Visit ...................................................................................... 24 23. Cycle treatment program ................................................................................................ 25 23.1 Non-Responders ...................................................................................................... 25 23.2 Responders ............................................................................................................ 26 23.3 Pregnancy ............................................................................................................... 27 23.4 Dispensing of Study Drug before Every Cycle ....................................................... 27 23.5 Breaks in Study Protocol ........................................................................................ 27 1 Downloaded From: https://jamanetwork.com/ on 09/30/2021 PCOSAct Protocol 8.1 23.6 Pregnancy Visits ..................................................................................................... 28 23.7 End of Treatment Visit ........................................................................................... 28 23.8 Final Pregnancy Outcome data ............................................................................. 28 24. Randomization ................................................................................................................ 29 25. Treatment Arms ............................................................................................................... 29 25.1 Acupuncture protocols 1 and 2 .............................................................................. 29 25.2 Clomiphene citrate (CC) and Placebo CC ............................................................... 31 25.3 Study Drugs packaged and dispensed ................................................................... 31 26. Monitoring ........................................................................................................................ 32 27. Outcome measures ........................................................................................................... 32 27.1 Primary outcomes: Live birth rate ......................................................................... 32 27.2 Secondary outcomes: ............................................................................................. 32 28. Timeline and Recruitment Plan ........................................................................................ 32 29. Statistics ........................................................................................................................... 33 29.1 Statistical tests ....................................................................................................... 33 29.2 Sample size estimation .......................................................................................... 33 30. References ....................................................................................................................... 34 31. Assessment of safety, quality control and quality assurance ........................................ 37 31.1 Safety analysis ......................................................................................................... 37 31.2 Interim Analysis ...................................................................................................... 37 32. Data and Safety Monitoring Board (DSMB) and Ethics ................................................. 37 32.1 DSMB ...................................................................................................................... 37 32.2 DSMB Members ..................................................................................................... 38 32.3 Ethics ...................................................................................................................... 38 33. Data Handling and record keeping ................................................................................. 38 33.1 Data Entry and Forms ............................................................................................. 39 33.2 Data Security .........................................................................................................
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