Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol
Abstract Background The variability of published acupuncture protocols for patients undergoing In-Vitro Fertilization (IVF) complicates the interpretation of data and hinders our understanding of acupuncture’s impact. In 2012, an acupuncture treatment protocol developed by a Delphi consensus process...
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| Format: | Article |
| Language: | English |
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BMC
2017-04-01
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| Series: | BMC Complementary and Alternative Medicine |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12906-017-1693-4 |
| _version_ | 1818531683115204608 |
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| author | Yan Zhang Jennifer Phy Chris Scott-Johnson Sheila Garos Jennie Orlando Samuel Prien Jaou-Chen Huang |
| author_facet | Yan Zhang Jennifer Phy Chris Scott-Johnson Sheila Garos Jennie Orlando Samuel Prien Jaou-Chen Huang |
| author_sort | Yan Zhang |
| collection | DOAJ |
| description | Abstract Background The variability of published acupuncture protocols for patients undergoing In-Vitro Fertilization (IVF) complicates the interpretation of data and hinders our understanding of acupuncture’s impact. In 2012, an acupuncture treatment protocol developed by a Delphi consensus process was published to describe the parameters of best practice acupuncture for Assisted Reproductive Technology and future research. However, there has been no clinical trial utilizing this protocol to assess the effects of acupuncture. This study aims to assess the implementation of Dephi consensus acupuncture protocol and to examine the impact of acupuncture on stress and uterine and ovarian blood flow among women between ages 21-42 years seeking IVF. Methods/Design This study is a one site prospective, two-arm randomized controlled non-blind clinical trial conducted in a medical school-affiliated fertility center . Participants will be randomized 1:1 into either the acupuncture group or the standard of care (no acupuncture) group using computer generated tables. Both groups will have 3 regular clinical visits as their standard IVF care during an approximately 2 to 3 weeks window. Women who are randomized into the acupuncture group would receive three sessions based on the Delphi consensus acupuncture protocol in addition to the standard care. The first treatment will be administered between days 6 to 8 of the stimulated IVF cycle. The second session will be performed on the day of embryo transfer at least 1 h prior to the transfer. The third session will be performed within 48 h post-embryo transfer. Participants will be followed for their pregnancy test and pregnancy outcome when applicable. The outcomes stress and blood flow will be measured by a validated perceived stress scale and vasoactive molecules, respectively. Discussion Although recruitment and scheduling could be challenging at times, the Delphi consensus acupuncture protocol was implemented as planned and well-accepted by the patients. Because of the time-specified sessions around patients’ IVF cycle, it is highly recommended to have on-site study acupuncturist(s) to accommodate the schedule. Trial Registration ClinicalTrials NCT02591186 registered on October 7, 2015. |
| first_indexed | 2024-12-11T17:35:38Z |
| format | Article |
| id | doaj.art-5a528234e7934c15b28874a34e67d9a9 |
| institution | Directory Open Access Journal |
| issn | 1472-6882 |
| language | English |
| last_indexed | 2024-12-11T17:35:38Z |
| publishDate | 2017-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Complementary and Alternative Medicine |
| spelling | doaj.art-5a528234e7934c15b28874a34e67d9a92022-12-22T00:56:41ZengBMCBMC Complementary and Alternative Medicine1472-68822017-04-011711710.1186/s12906-017-1693-4Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocolYan Zhang0Jennifer Phy1Chris Scott-Johnson2Sheila Garos3Jennie Orlando4Samuel Prien5Jaou-Chen Huang6Department of Family and Community Medicine, Texas Tech University Health Sciences CenterDepartment of OB-GYN, Center for Fertility and Reproductive Surgery, Texas Tech University Health Sciences CenterClinical Research Institute (CRI), Texas Tech University Health Sciences CenterDepartment of Psychological Sciences, Texas Tech UniversityDepartment of OB-GYN, Center for Fertility and Reproductive Surgery, Texas Tech University Health Sciences CenterDepartment of OB-GYN, Center for Fertility and Reproductive Surgery, Texas Tech University Health Sciences CenterDepartment of OB-GYN, Center for Fertility and Reproductive Surgery, Texas Tech University Health Sciences CenterAbstract Background The variability of published acupuncture protocols for patients undergoing In-Vitro Fertilization (IVF) complicates the interpretation of data and hinders our understanding of acupuncture’s impact. In 2012, an acupuncture treatment protocol developed by a Delphi consensus process was published to describe the parameters of best practice acupuncture for Assisted Reproductive Technology and future research. However, there has been no clinical trial utilizing this protocol to assess the effects of acupuncture. This study aims to assess the implementation of Dephi consensus acupuncture protocol and to examine the impact of acupuncture on stress and uterine and ovarian blood flow among women between ages 21-42 years seeking IVF. Methods/Design This study is a one site prospective, two-arm randomized controlled non-blind clinical trial conducted in a medical school-affiliated fertility center . Participants will be randomized 1:1 into either the acupuncture group or the standard of care (no acupuncture) group using computer generated tables. Both groups will have 3 regular clinical visits as their standard IVF care during an approximately 2 to 3 weeks window. Women who are randomized into the acupuncture group would receive three sessions based on the Delphi consensus acupuncture protocol in addition to the standard care. The first treatment will be administered between days 6 to 8 of the stimulated IVF cycle. The second session will be performed on the day of embryo transfer at least 1 h prior to the transfer. The third session will be performed within 48 h post-embryo transfer. Participants will be followed for their pregnancy test and pregnancy outcome when applicable. The outcomes stress and blood flow will be measured by a validated perceived stress scale and vasoactive molecules, respectively. Discussion Although recruitment and scheduling could be challenging at times, the Delphi consensus acupuncture protocol was implemented as planned and well-accepted by the patients. Because of the time-specified sessions around patients’ IVF cycle, it is highly recommended to have on-site study acupuncturist(s) to accommodate the schedule. Trial Registration ClinicalTrials NCT02591186 registered on October 7, 2015.http://link.springer.com/article/10.1186/s12906-017-1693-4AcupunctureDelphi consensus protocolIVF |
| spellingShingle | Yan Zhang Jennifer Phy Chris Scott-Johnson Sheila Garos Jennie Orlando Samuel Prien Jaou-Chen Huang Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol BMC Complementary and Alternative Medicine Acupuncture Delphi consensus protocol IVF |
| title | Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol |
| title_full | Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol |
| title_fullStr | Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol |
| title_full_unstemmed | Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol |
| title_short | Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol |
| title_sort | effects of a delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in vitro fertilization a randomized clinical trial protocol |
| topic | Acupuncture Delphi consensus protocol IVF |
| url | http://link.springer.com/article/10.1186/s12906-017-1693-4 |
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