Effect of Acupuncture on Vascular Biomarkers and Psychological Well-Being of Women Undergoing IVF (AcupunctIVF)
11. september 2020 opdateret af: 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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Texas
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Lubbock, Texas, Forenede Stater, 79430
- Texas Tech Health Science Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år til 42 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Ingen indgriben: Control
Control arm not receiving acupuncture during IVF process
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Urine prostacyclin before and after acupuncture
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Jennifer L Phy, DO, Texas Tech University Health Sciences Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. november 2015
Primær færdiggørelse (Faktiske)
1. juli 2020
Studieafslutning (Faktiske)
1. september 2020
Datoer for studieregistrering
Først indsendt
7. oktober 2015
Først indsendt, der opfyldte QC-kriterier
28. oktober 2015
Først opslået (Skøn)
29. oktober 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. september 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- L15-117
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