Effect of Acupuncture on Vascular Biomarkers and Psychological Well-Being of Women Undergoing IVF (AcupunctIVF)
11 september 2020 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Texas
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Lubbock, Texas, Förenta staterna, 79430
- Texas Tech Health Science Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år till 42 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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.***
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Inget ingripande: Control
Control arm not receiving acupuncture during IVF process
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Urine prostacyclin before and after acupuncture
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Jennifer L Phy, DO, Texas Tech University Health Sciences Center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 november 2015
Primärt slutförande (Faktisk)
1 juli 2020
Avslutad studie (Faktisk)
1 september 2020
Studieregistreringsdatum
Först inskickad
7 oktober 2015
Först inskickad som uppfyllde QC-kriterierna
28 oktober 2015
Första postat (Uppskatta)
29 oktober 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 september 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 september 2020
Senast verifierad
1 september 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- L15-117
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