Effect of Acupuncture on Vascular Biomarkers and Psychological Well-Being of Women Undergoing IVF (AcupunctIVF)
11 de septiembre de 2020 actualizado por: Texas Tech University Health Sciences Center
Effect of Acupuncture on Vascular Biomarkers and Psychological Well-Being of Women Undergoing In Vitro Fertilization (IVF)
Experimental Approach: (1) Participants: Women (ages 21 to 42) who seek IVF treatment at the Center for Fertility & Reproductive Surgery will be eligible for the study.
Seventy women will be recruited and randomly assigned to either the intervention (acupuncture plus standard care) or the comparison (standard care alone) group.
(2) Intervention: Participants in the intervention group will receive 3 acupuncture sessions during the project with the first treatment between day 6-8 of the stimulated IVF cycle, second on the day of embryo transfer and the third one day post transfer.
Participants in the comparison group will receive no intervention but will receive standard care.
(3) Measures: The primary outcome measures include prostacyclin and thromboxane vasoactive biomarkers.
Secondary outcome measures include perceived stress levels.
(4) Procedure: Upon IRB approval, an informed consent will be provided to all participants.
Pre- and post- acupuncture urinary metabolites of prostacyclin and thromboxane will be assessed.
A standardized Perceived Stress Scale will be administered before and after each acupuncture session for the study group, and before and after a 30-40-minute waiting period for the control group.
Descripción general del estudio
Descripción detallada
Hypothesis and Specific Aims
The purpose of this pilot study is to determine if acupuncture affects the vasoactive molecules (prostacyclin and thromboxane) in women undergoing IVF therapy. The investigators' overall hypotheses for this area of study, to be addressed with future research, are: (1) acupuncture augments IVF success by enhancing the perfusion of pelvic organs including the ovaries and the uterus, and (2) acupuncture reduces the levels of stress and optimizes mind-body interaction in individuals undergoing IVF.
Specific Aims:
- To measure urine prostacyclin and thromboxane, before and after acupuncture, and
- to assess the impacts of acupuncture on the psychological well-being of women undergoing IVF treatment.
SIGNIFICANCE OF THE STUDY Results from this study will shed light on the mechanism by which acupuncture improves IVF outcomes. This may lead to other treatment strategies to improve success. Likewise, an established mechanism by which acupuncture improves IVF may lead to greater acceptance of this non-conventional treatment modality by the general population.
Research Design and Methods
This is a prospective, randomized, controlled study. Participants will be women in the Principal Investigator's practice seeking IVF. Participants will be randomized 1:1 into either the acupuncture group or the standard of care (no acupuncture) group. Each group will have 3 study visits.
Rationale for the Control Group:
A sham control group is not used because systematic review suggested that sham acupuncture controls may unnecessarily complicate the RCT evidence base given the nature of objective outcomes in IVF study (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3124624/).
Power analysis
With 35 patients allocated to each group, assuming the Student's T-test will be used to determine the differences between two independent samples, effect sizes d>0.6 will be found statistically significant with alpha .05 and power .80. In practical terms, since the PSS validation samples showed a mean about 13.5 with variance=6.2, only averaged differences greater than 1.5 raw score points in PSS will be found statistically significant.
The investigators plan to seek extramural funding in the future. The investigators will use the data obtained from this pilot study to perform power analysis and to calculate the number of participants needed in future proposals.
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Texas
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Lubbock, Texas, Estados Unidos, 79430
- Texas Tech Health Science Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
21 años a 42 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Women between ages 21-42 years seeking IVF.
- Willing to undergo acupuncture
- No contraindications to needle insertion.
Exclusion Criteria:
- Women currently using alternative therapies such as acupressure, herbal supplements and meditation techniques.
- Women with generalized psoriasis, neuropathy or coagulopathies posing increased risk due to needle insertion.
- Women with previous experience with acupuncture.
***Please note that we are unable to give a discount on IVF cost for participating in the study.***
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Acupuncture arm
Participants receiving acupuncture during IVF process
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Participants will receive 3 acupuncture sessions during IVF process
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Sin intervención: Control
Control arm not receiving acupuncture during IVF process
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Urine prostacyclin before and after acupuncture
Periodo de tiempo: Within 8-week course of IVF treatment
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Measurement of the vasoactive molecule prostacyclin (pg/mg creatinine) in women undergoing IVF therapy.
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Within 8-week course of IVF treatment
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Urine thromboxane before and after acupuncture
Periodo de tiempo: Within 8-week course of IVF treatment
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Measurement of the vasoactive molecule thromboxane (pg/mg creatinine) in women undergoing IVF therapy.
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Within 8-week course of IVF treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jennifer L Phy, DO, Texas Tech University Health Sciences Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de noviembre de 2015
Finalización primaria (Actual)
1 de julio de 2020
Finalización del estudio (Actual)
1 de septiembre de 2020
Fechas de registro del estudio
Enviado por primera vez
7 de octubre de 2015
Primero enviado que cumplió con los criterios de control de calidad
28 de octubre de 2015
Publicado por primera vez (Estimar)
29 de octubre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de septiembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2020
Última verificación
1 de septiembre de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- L15-117
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .