InfertilityAcupunctIVFNCT02591186
Effect of Acupuncture on Vascular Biomarkers and Psychological Well-Being of Women Undergoing IVF
A study testing Acupuncture in people with Infertility, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2015to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between ages 21-42 years seeking IVF.
- Willing to undergo acupuncture
- No contraindications to needle insertion.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech Health Science Center
Lubbock, Texas, 79430
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Infertility
- Being tested
- Acupuncture
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Participants will receive 3 acupuncture sessions during IVF process
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture arm | Experimental | Participants receiving acupuncture during IVF process Receives: Procedure: Acupuncture |
| Control | No intervention | Control arm not receiving acupuncture during IVF process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine prostacyclin before and after acupuncture
Measurement of the vasoactive molecule prostacyclin (pg/mg creatinine) in women undergoing IVF therapy.
Measured: Within 8-week course of IVF treatment
Urine thromboxane before and after acupuncture
Measurement of the vasoactive molecule thromboxane (pg/mg creatinine) in women undergoing IVF therapy.
Measured: Within 8-week course of IVF treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start1 Nov 2015
- Primary completion1 Jul 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer L Phy, DO, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591186
- Sponsor's protocol ID
- L15-117
- Acronym
- AcupunctIVF
- Status last verified
- Sep 2020
- First submitted
- 7 Oct 2015
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lim H, Paria BC, Das SK, Dinchuk JE, Langenbach R, Trzaskos JM, Dey SK. Multiple female reproductive failures in cyclooxygenase 2-deficient mice. Cell. 1997 Oct 17;91(2):197-208. doi: 10.1016/s0092-8674(00)80402-x.
PubMed 9346237Pandian Z, Bhattacharya S, Ozturk O, Serour G, Templeton A. Number of embryos for transfer following in-vitro fertilisation or intra-cytoplasmic sperm injection. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003416. doi: 10.1002/14651858.CD003416.pub3.
PubMed 19370588Anderson BJ, Haimovici F, Ginsburg ES, Schust DJ, Wayne PM. In vitro fertilization and acupuncture: clinical efficacy and mechanistic basis. Altern Ther Health Med. 2007 May-Jun;13(3):38-48.
PubMed 17515023Manheimer E, Zhang G, Udoff L, Haramati A, Langenberg P, Berman BM, Bouter LM. Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: systematic review and meta-analysis. BMJ. 2008 Mar 8;336(7643):545-9. doi: 10.1136/bmj.39471.430451.BE. Epub 2008 Feb 7.
PubMed 18258932Huang JC, Wun WS, Goldsby JS, Egan K, FitzGerald GA, Wu KK. Prostacyclin receptor signaling and early embryo development in the mouse. Hum Reprod. 2007 Nov;22(11):2851-6. doi: 10.1093/humrep/dem304. Epub 2007 Sep 28.
PubMed 17905746Huang JC, Goldsby JS, Wun WS. Prostacyclin enhances the implantation and live birth potentials of mouse embryos. Hum Reprod. 2004 Aug;19(8):1856-60. doi: 10.1093/humrep/deh352. Epub 2004 Jun 17.
PubMed 15205402Ruan KH, Deng H, So SP. Engineering of a protein with cyclooxygenase and prostacyclin synthase activities that converts arachidonic acid to prostacyclin. Biochemistry. 2006 Nov 28;45(47):14003-11. doi: 10.1021/bi0614277.
PubMed 17115695Majerus PW. Arachidonate metabolism in vascular disorders. J Clin Invest. 1983 Nov;72(5):1521-5. doi: 10.1172/JCI111110. No abstract available.
PubMed 6313764Samuelsson B, Goldyne M, Granstrom E, Hamberg M, Hammarstrom S, Malmsten C. Prostaglandins and thromboxanes. Annu Rev Biochem. 1978;47:997-1029. doi: 10.1146/annurev.bi.47.070178.005025. No abstract available.
PubMed 209733Smith WL. Prostaglandin biosynthesis and its compartmentation in vascular smooth muscle and endothelial cells. Annu Rev Physiol. 1986;48:251-62. doi: 10.1146/annurev.ph.48.030186.001343.
PubMed 3085582Funk CD. Prostaglandins and leukotrienes: advances in eicosanoid biology. Science. 2001 Nov 30;294(5548):1871-5. doi: 10.1126/science.294.5548.1871.
PubMed 11729303Ruan KH. Advance in understanding the biosynthesis of prostacyclin and thromboxane A2 in the endoplasmic reticulum membrane via the cyclooxygenase pathway. Mini Rev Med Chem. 2004 Aug;4(6):639-47. doi: 10.2174/1389557043403710.
PubMed 15279598Ruan KH, Dogne JM. Implications of the molecular basis of prostacyclin biosynthesis and signaling in pharmaceutical designs. Curr Pharm Des. 2006;12(8):925-41. doi: 10.2174/138161206776055994.
PubMed 16533160Dogne JM, Hanson J, de Leval X, Pratico D, Pace-Asciak CR, Drion P, Pirotte B, Ruan KH. From the design to the clinical application of thromboxane modulators. Curr Pharm Des. 2006;12(8):903-23. doi: 10.2174/138161206776055921.
PubMed 16533159Needleman P, Turk J, Jakschik BA, Morrison AR, Lefkowith JB. Arachidonic acid metabolism. Annu Rev Biochem. 1986;55:69-102. doi: 10.1146/annurev.bi.55.070186.000441. No abstract available.
PubMed 3017195
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Vascular Biomarkers and Psychological Well-Being of Women Undergoing In Vitro Fertilization (IVF)
- ClinicalTrials.gov ID
- NCT02591186
- Acronym / sponsor ID
- AcupunctIVF / L15-117
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture arm | Experimental | Procedure: AcupunctureParticipants receiving acupuncture during IVF process |
| Control | No intervention | –Control arm not receiving acupuncture during IVF process |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women between ages 21-42 years seeking IVF.
- Willing to undergo acupuncture
- No contraindications to needle insertion.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureParticipants will receive 3 acupuncture sessions during IVF process | Procedure or surgery | Acupuncture arm |
Primary outcome
Urine prostacyclin before and after acupuncture
Time frame: Within 8-week course of IVF treatment
Measurement of the vasoactive molecule prostacyclin (pg/mg creatinine) in women undergoing IVF therapy.
Urine thromboxane before and after acupuncture
Time frame: Within 8-week course of IVF treatment
Measurement of the vasoactive molecule thromboxane (pg/mg creatinine) in women undergoing IVF therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 9346237Lim H, Paria BC, Das SK, Dinchuk JE, Langenbach R, Trzaskos JM, Dey SK. Multiple female reproductive failures in cyclooxygenase 2-deficient mice. Cell. 1997 Oct 17;91(2):197-208. doi: 10.1016/s0092-8674(00)80402-x.
- Background: PubMed 19370588Pandian Z, Bhattacharya S, Ozturk O, Serour G, Templeton A. Number of embryos for transfer following in-vitro fertilisation or intra-cytoplasmic sperm injection. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003416. doi: 10.1002/14651858.CD003416.pub3.
- Background: PubMed 17515023Anderson BJ, Haimovici F, Ginsburg ES, Schust DJ, Wayne PM. In vitro fertilization and acupuncture: clinical efficacy and mechanistic basis. Altern Ther Health Med. 2007 May-Jun;13(3):38-48.
- Background: PubMed 18258932Manheimer E, Zhang G, Udoff L, Haramati A, Langenberg P, Berman BM, Bouter LM. Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: systematic review and meta-analysis. BMJ. 2008 Mar 8;336(7643):545-9. doi: 10.1136/bmj.39471.430451.BE. Epub 2008 Feb 7.
- Background: PubMed 17905746Huang JC, Wun WS, Goldsby JS, Egan K, FitzGerald GA, Wu KK. Prostacyclin receptor signaling and early embryo development in the mouse. Hum Reprod. 2007 Nov;22(11):2851-6. doi: 10.1093/humrep/dem304. Epub 2007 Sep 28.
- Background: PubMed 15205402Huang JC, Goldsby JS, Wun WS. Prostacyclin enhances the implantation and live birth potentials of mouse embryos. Hum Reprod. 2004 Aug;19(8):1856-60. doi: 10.1093/humrep/deh352. Epub 2004 Jun 17.
- Background: PubMed 17115695Ruan KH, Deng H, So SP. Engineering of a protein with cyclooxygenase and prostacyclin synthase activities that converts arachidonic acid to prostacyclin. Biochemistry. 2006 Nov 28;45(47):14003-11. doi: 10.1021/bi0614277.
- Background: PubMed 6313764Majerus PW. Arachidonate metabolism in vascular disorders. J Clin Invest. 1983 Nov;72(5):1521-5. doi: 10.1172/JCI111110. No abstract available.
- Background: PubMed 209733Samuelsson B, Goldyne M, Granstrom E, Hamberg M, Hammarstrom S, Malmsten C. Prostaglandins and thromboxanes. Annu Rev Biochem. 1978;47:997-1029. doi: 10.1146/annurev.bi.47.070178.005025. No abstract available.
- Background: PubMed 3085582Smith WL. Prostaglandin biosynthesis and its compartmentation in vascular smooth muscle and endothelial cells. Annu Rev Physiol. 1986;48:251-62. doi: 10.1146/annurev.ph.48.030186.001343.
- Background: PubMed 11729303Funk CD. Prostaglandins and leukotrienes: advances in eicosanoid biology. Science. 2001 Nov 30;294(5548):1871-5. doi: 10.1126/science.294.5548.1871.
- Background: PubMed 15279598Ruan KH. Advance in understanding the biosynthesis of prostacyclin and thromboxane A2 in the endoplasmic reticulum membrane via the cyclooxygenase pathway. Mini Rev Med Chem. 2004 Aug;4(6):639-47. doi: 10.2174/1389557043403710.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Phy, DO principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Infertility, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine prostacyclin before and after acupuncture (time frame: Within 8-week course of IVF treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591186, which also lists 63 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.