Effect of Acupuncture on Vascular Biomarkers and Psychological Well-Being of Women Undergoing IVF

NCT02591186 | Completed

• 1 other identifier: L15-117
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

• Urine prostacyclin before and after acupuncture

  Measurement of the vasoactive molecule prostacyclin (pg/mg creatinine) in women undergoing IVF therapy.

  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.

  Within 8-week course of IVF treatment

Study Arms (2)

Acupuncture arm

EXPERIMENTAL

Participants receiving acupuncture during IVF process

Procedure: Acupuncture

Control

NO INTERVENTION

Control arm not receiving acupuncture during IVF process

Interventions

Acupuncture PROCEDURE

Participants will receive 3 acupuncture sessions during IVF process

Acupuncture arm

Eligibility Criteria

• Age: 21 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between ages 21-42 years seeking IVF.
• Willing to undergo acupuncture
• No contraindications to needle insertion.

You may not qualify if:

• 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.\*\*\*

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech Health Science Center

Lubbock, Texas, 79430, United States

Location

Related Publications (63)

• 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.

  PMID: 9346237 BACKGROUND

• Pandian 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.

  PMID: 19370588 BACKGROUND

• Anderson 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.

  PMID: 17515023 BACKGROUND

• Manheimer 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.

  PMID: 18258932 BACKGROUND

• Huang 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.

  PMID: 17905746 BACKGROUND

• Huang 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.

  PMID: 15205402 BACKGROUND

• Ruan 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.

  PMID: 17115695 BACKGROUND

• Majerus PW. Arachidonate metabolism in vascular disorders. J Clin Invest. 1983 Nov;72(5):1521-5. doi: 10.1172/JCI111110. No abstract available.

  PMID: 6313764 BACKGROUND

• Samuelsson 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.

  PMID: 209733 BACKGROUND

• Smith 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.

  PMID: 3085582 BACKGROUND

• Funk CD. Prostaglandins and leukotrienes: advances in eicosanoid biology. Science. 2001 Nov 30;294(5548):1871-5. doi: 10.1126/science.294.5548.1871.

  PMID: 11729303 BACKGROUND

• Ruan 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.

  PMID: 15279598 BACKGROUND

• Ruan 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.

  PMID: 16533160 BACKGROUND

• Dogne 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.

  PMID: 16533159 BACKGROUND

• Needleman 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.

  PMID: 3017195 BACKGROUND

• Bunting S, Gryglewski R, Moncada S, Vane JR. Arterial walls generate from prostaglandin endoperoxides a substance (prostaglandin X) which relaxes strips of mesenteric and coeliac ateries and inhibits platelet aggregation. Prostaglandins. 1976 Dec;12(6):897-913. doi: 10.1016/0090-6980(76)90125-8.

  PMID: 1005741 BACKGROUND

• Moncada S, Herman AG, Higgs EA, Vane JR. Differential formation of prostacyclin (PGX or PGI2) by layers of the arterial wall. An explanation for the anti-thrombotic properties of vascular endothelium. Thromb Res. 1977 Sep;11(3):323-44. doi: 10.1016/0049-3848(77)90185-2. No abstract available.

  PMID: 335560 BACKGROUND

• Weksler BB, Ley CW, Jaffe EA. Stimulation of endothelial cell prostacyclin production by thrombin, trypsin, and the ionophore A 23187. J Clin Invest. 1978 Nov;62(5):923-30. doi: 10.1172/JCI109220.

  PMID: 361756 BACKGROUND

• Ingerman-Wojenski C, Silver MJ, Smith JB, Macarak E. Bovine endothelial cells in culture produce thromboxane as well as prostacyclin. J Clin Invest. 1981 May;67(5):1292-6. doi: 10.1172/jci110157.

  PMID: 7014633 BACKGROUND

• Smith WL, DeWitt DL, Allen ML. Bimodal distribution of the prostaglandin I2 synthase antigen in smooth muscle cells. J Biol Chem. 1983 May 10;258(9):5922-6.

  PMID: 6406508 BACKGROUND

• Coceani F, Ackerley C, Seidlitz E, Kelsey L. Function of cyclo-oxygenase-1 and cyclo-oxygenase-2 in the ductus arteriosus from foetal lamb: differential development and change by oxygen and endotoxin. Br J Pharmacol. 2001 Jan;132(1):241-51. doi: 10.1038/sj.bjp.0703779.

  PMID: 11156583 BACKGROUND

• Pakrasi PL, Jain AK. Cyclooxygenase-2-derived endogenous prostacyclin reduces apoptosis and enhances embryo viability in mouse. Prostaglandins Leukot Essent Fatty Acids. 2008 Jul-Aug;79(1-2):27-33. doi: 10.1016/j.plefa.2008.07.006. Epub 2008 Sep 3.

  PMID: 18771909 BACKGROUND

• Stener-Victorin E, Waldenstrom U, Andersson SA, Wikland M. Reduction of blood flow impedance in the uterine arteries of infertile women with electro-acupuncture. Hum Reprod. 1996 Jun;11(6):1314-7. doi: 10.1093/oxfordjournals.humrep.a019378.

  PMID: 8671446 BACKGROUND

• Uchida S, Hotta H. Acupuncture affects regional blood flow in various organs. Evid Based Complement Alternat Med. 2008 Jun;5(2):145-51. doi: 10.1093/ecam/nem051.

  PMID: 18604254 BACKGROUND

• Zhang S, Ye X, Shan Q, Zhang W, Ye L, Cui Y. Effects of acupuncture on the levels of endothelin, TXB2, and 6-keto-PGF1 alpha in apoplexy patients. J Tradit Chin Med. 1999 Mar;19(1):39-43.

  PMID: 10453582 BACKGROUND

• Xu N. [Effect of electroacupuncture at "taixi" point on plasma thromboxane A2 and prostacyclin in the rabbit with renal ischemia]. Zhen Ci Yan Jiu. 1993;18(3):240-2. Chinese.

  PMID: 7923725 BACKGROUND

• Yuan J, Westney OL, Ruan KH, Wang R. A new strategy, SuperEnzyme gene therapy in penile rehabilitation. J Sex Med. 2009 Mar;6 Suppl 3:328-33. doi: 10.1111/j.1743-6109.2008.01191.x.

  PMID: 19267856 BACKGROUND

• Ruan KH, So SP, Cervantes V, Wu H, Wijaya C, Jentzen RR. An active triple-catalytic hybrid enzyme engineered by linking cyclo-oxygenase isoform-1 to prostacyclin synthase that can constantly biosynthesize prostacyclin, the vascular protector. FEBS J. 2008 Dec;275(23):5820-9. doi: 10.1111/j.1742-4658.2008.06703.x.

  PMID: 19021758 BACKGROUND

• Ruan KH, So SP, Wu H, Cervantes V. Large-scale expression, purification, and characterization of an engineered prostacyclin-synthesizing enzyme with therapeutic potential. Arch Biochem Biophys. 2008 Dec 1;480(1):41-50. doi: 10.1016/j.abb.2008.09.010. Epub 2008 Sep 22.

  PMID: 18835243 BACKGROUND

• Ruan KH, Wu J, Cervantes V. Characterization of the substrate mimic bound to engineered prostacyclin synthase in solution using high-resolution NMR spectroscopy and mutagenesis: implication of the molecular mechanism in biosynthesis of prostacyclin. Biochemistry. 2008 Jan 15;47(2):680-8. doi: 10.1021/bi701671q. Epub 2007 Dec 15.

  PMID: 18081314 BACKGROUND

• Ruan KH, Deng H, Wu J, So SP. The N-terminal membrane anchor domain of the membrane-bound prostacyclin synthase involved in the substrate presentation of the coupling reaction with cyclooxygenase. Arch Biochem Biophys. 2005 Mar 15;435(2):372-81. doi: 10.1016/j.abb.2004.12.018.

  PMID: 15708381 BACKGROUND

• Ni F, So SP, Cervantes V, Ruan KH. A profile of the residues in the second extracellular loop that are critical for ligand recognition of human prostacyclin receptor. FEBS J. 2008 Jan;275(1):128-37. doi: 10.1111/j.1742-4658.2007.06183.x. Epub 2007 Nov 27.

  PMID: 18042246 BACKGROUND

• Zhang L, Bastepe M, Juppner H, Ruan KH. Characterization of the molecular mechanisms of the coupling between intracellular loops of prostacyclin receptor with the C-terminal domain of the Galphas protein in human coronary artery smooth muscle cells. Arch Biochem Biophys. 2006 Oct 1;454(1):80-8. doi: 10.1016/j.abb.2006.06.023. Epub 2006 Jul 25.

  PMID: 16942748 BACKGROUND

• Zhang L, Wu J, Ruan KH. Solution structure of the first intracellular loop of prostacyclin receptor and implication of its interaction with the C-terminal segment of G alpha s protein. Biochemistry. 2006 Feb 14;45(6):1734-44. doi: 10.1021/bi0515669.

  PMID: 16460020 BACKGROUND

• Ruan CH, Wu J, Ruan KH. A strategy using NMR peptide structures of thromboxane A2 receptor as templates to construct ligand-recognition pocket of prostacyclin receptor. BMC Biochem. 2005 Nov 4;6:23. doi: 10.1186/1471-2091-6-23.

  PMID: 16271145 BACKGROUND

• Zhang L, Huang G, Wu J, Ruan KH. A profile of the residues in the first intracellular loop critical for Gs-mediated signaling of human prostacyclin receptor characterized by an integrative approach of NMR-experiment and mutagenesis. Biochemistry. 2005 Aug 30;44(34):11389-401. doi: 10.1021/bi050483p.

  PMID: 16114876 BACKGROUND

• Ruan KH, Wu J, So SP, Jenkins LA. Evidence of the residues involved in ligand recognition in the second extracellular loop of the prostacyclin receptor characterized by high resolution 2D NMR techniques. Arch Biochem Biophys. 2003 Oct 1;418(1):25-33. doi: 10.1016/s0003-9861(03)00401-6.

  PMID: 13679079 BACKGROUND

• Ruan KH, Wu J, Wang LH. Solution structure of a common substrate mimetic of cyclooxygenase-downstream synthases bound to an engineered thromboxane A2 synthase using a high-resolution NMR technique. Arch Biochem Biophys. 2005 Dec 15;444(2):165-73. doi: 10.1016/j.abb.2005.10.010. Epub 2005 Nov 2.

  PMID: 16297851 BACKGROUND

• So SP, Li D, Ruan KH. Identification of the substrate interaction site in the N-terminal membrane anchor segment of thromboxane A2 synthase by determination of its substrate analog conformational changes using high resolution NMR technique. J Biol Chem. 2000 Dec 29;275(52):40679-85. doi: 10.1074/jbc.M005752200.

  PMID: 11006279 BACKGROUND

• Ruan KH, Li D, Ji J, Lin YZ, Gao X. Structural characterization and topology of the second potential membrane anchor region in the thromboxane A2 synthase amino-terminal domain. Biochemistry. 1998 Jan 20;37(3):822-30. doi: 10.1021/bi971881y.

  PMID: 9454571 BACKGROUND

• Ruan KH, Cervantes V, Wu J. Ligand-specific conformation determines agonist activation and antagonist blockade in purified human thromboxane A2 receptor. Biochemistry. 2009 Apr 14;48(14):3157-65. doi: 10.1021/bi801443g.

  PMID: 19170518 BACKGROUND

• Ruan KH, Wijaya C, Cervantes V, Wu J. Characterization of the prostaglandin H2 mimic: binding to the purified human thromboxane A2 receptor in solution. Arch Biochem Biophys. 2008 Sep 15;477(2):396-403. doi: 10.1016/j.abb.2008.05.022. Epub 2008 Jun 17.

  PMID: 18590695 BACKGROUND

• Ruan KH, Cervantes V, Wu J. A simple, quick, and high-yield preparation of the human thromboxane A2 receptor in full size for structural studies. Biochemistry. 2008 Jul 1;47(26):6819-26. doi: 10.1021/bi702501g. Epub 2008 Jun 5.

  PMID: 18529068 BACKGROUND

• Wu J, Feng M, Ruan KH. Assembling NMR structures for the intracellular loops of the human thromboxane A2 receptor: implication of the G protein-coupling pocket. Arch Biochem Biophys. 2008 Feb 1;470(1):73-82. doi: 10.1016/j.abb.2007.11.016. Epub 2007 Dec 3.

  PMID: 18073117 BACKGROUND

• Ruan KH, Wu J, So SP, Jenkins LA, Ruan CH. NMR structure of the thromboxane A2 receptor ligand recognition pocket. Eur J Biochem. 2004 Jul;271(14):3006-16. doi: 10.1111/j.1432-1033.2004.04232.x.

  PMID: 15233797 BACKGROUND

• Geng L, Wu J, So SP, Huang G, Ruan KH. Structural and functional characterization of the first intracellular loop of human thromboxane A2 receptor. Arch Biochem Biophys. 2004 Mar 15;423(2):253-65. doi: 10.1016/j.abb.2004.01.001.

  PMID: 15001390 BACKGROUND

• Wu J, So SP, Ruan KH. Solution structure of the third extracellular loop of human thromboxane A2 receptor. Arch Biochem Biophys. 2003 Jun 15;414(2):287-93. doi: 10.1016/s0003-9861(03)00192-9.

  PMID: 12781781 BACKGROUND

• So SP, Wu J, Huang G, Huang A, Li D, Ruan KH. Identification of residues important for ligand binding of thromboxane A2 receptor in the second extracellular loop using the NMR experiment-guided mutagenesis approach. J Biol Chem. 2003 Mar 28;278(13):10922-7. doi: 10.1074/jbc.M209337200. Epub 2003 Jan 27.

  PMID: 12551898 BACKGROUND

• Ruan KH, Cervantes V, So SP. Engineering of a novel hybrid enzyme: an anti-inflammatory drug target with triple catalytic activities directly converting arachidonic acid into the inflammatory prostaglandin E2. Protein Eng Des Sel. 2009 Dec;22(12):733-40. doi: 10.1093/protein/gzp058. Epub 2009 Oct 22.

  PMID: 19850676 BACKGROUND

• Chillar A, Wu J, So SP, Ruan KH. Involvement of non-conserved residues important for PGE2 binding to the constrained EP3 eLP2 using NMR and site-directed mutagenesis. FEBS Lett. 2008 Aug 20;582(19):2863-8. doi: 10.1016/j.febslet.2008.07.018. Epub 2008 Jul 22.

  PMID: 18652829 BACKGROUND

• Huang JC, Arbab F, Tumbusch KJ, Goldsby JS, Matijevic-Aleksic N, Wu KK. Human fallopian tubes express prostacyclin (PGI) synthase and cyclooxygenases and synthesize abundant PGI. J Clin Endocrinol Metab. 2002 Sep;87(9):4361-8. doi: 10.1210/jc.2002-020199.

  PMID: 12213900 BACKGROUND

• Arbab F, Goldsby J, Matijevic-Aleksic N, Huang G, Ruan KH, Huang JC. Prostacyclin is an autocrine regulator in the contraction of oviductal smooth muscle. Hum Reprod. 2002 Dec;17(12):3053-9. doi: 10.1093/humrep/17.12.3053.

  PMID: 12456602 BACKGROUND

• Huang JC, Goldsby JS, Arbab F, Melhem Z, Aleksic N, Wu KK. Oviduct prostacyclin functions as a paracrine factor to augment the development of embryos. Hum Reprod. 2004 Dec;19(12):2907-12. doi: 10.1093/humrep/deh520. Epub 2004 Oct 18.

  PMID: 15492023 BACKGROUND

• Huang JC, Wun WS, Goldsby JS, Matijevic-Aleksic N, Wu KK. Cyclooxygenase-2-derived endogenous prostacyclin enhances mouse embryo hatching. Hum Reprod. 2004 Dec;19(12):2900-6. doi: 10.1093/humrep/deh524. Epub 2004 Oct 15.

  PMID: 15489241 BACKGROUND

• Huang JC, Wun WS, Goldsby JS, Wun IC, Noorhasan D, Wu KK. Stimulation of embryo hatching and implantation by prostacyclin and peroxisome proliferator-activated receptor delta activation: implication in IVF. Hum Reprod. 2007 Mar;22(3):807-14. doi: 10.1093/humrep/del429. Epub 2006 Nov 17.

  PMID: 17114194 BACKGROUND

• de Lacey S, Smith CA, Paterson C. Building resilience: a preliminary exploration of women's perceptions of the use of acupuncture as an adjunct to In Vitro Fertilisation. BMC Complement Altern Med. 2009 Dec 12;9:50. doi: 10.1186/1472-6882-9-50.

  PMID: 20003370 BACKGROUND

• Ng EH, So WS, Gao J, Wong YY, Ho PC. The role of acupuncture in the management of subfertility. Fertil Steril. 2008 Jul;90(1):1-13. doi: 10.1016/j.fertnstert.2008.02.094. Epub 2008 Apr 28.

  PMID: 18440533 BACKGROUND

• Stener-Victorin E, Humaidan P. Use of acupuncture in female infertility and a summary of recent acupuncture studies related to embryo transfer. Acupunct Med. 2006 Dec;24(4):157-63. doi: 10.1136/aim.24.4.157.

  PMID: 17264833 BACKGROUND

• Ho M, Huang LC, Chang YY, Chen HY, Chang WC, Yang TC, Tsai HD. Electroacupuncture reduces uterine artery blood flow impedance in infertile women. Taiwan J Obstet Gynecol. 2009 Jun;48(2):148-51. doi: 10.1016/S1028-4559(09)60276-X.

  PMID: 19574177 BACKGROUND

• Huang JC, Wun WS, Goldsby JS, Wun IC, Falconi SM, Wu KK. Prostacyclin enhances embryo hatching but not sperm motility. Hum Reprod. 2003 Dec;18(12):2582-9. doi: 10.1093/humrep/deg490.

  PMID: 14645174 BACKGROUND

• Urbich C, Kuehbacher A, Dimmeler S. Role of microRNAs in vascular diseases, inflammation, and angiogenesis. Cardiovasc Res. 2008 Sep 1;79(4):581-8. doi: 10.1093/cvr/cvn156. Epub 2008 Jun 11.

  PMID: 18550634 BACKGROUND

• Planat-Benard V, Silvestre JS, Cousin B, Andre M, Nibbelink M, Tamarat R, Clergue M, Manneville C, Saillan-Barreau C, Duriez M, Tedgui A, Levy B, Penicaud L, Casteilla L. Plasticity of human adipose lineage cells toward endothelial cells: physiological and therapeutic perspectives. Circulation. 2004 Feb 10;109(5):656-63. doi: 10.1161/01.CIR.0000114522.38265.61. Epub 2004 Jan 20.

  PMID: 14734516 BACKGROUND

• Zhang Y, Phy J, Scott-Johnson C, Garos S, Orlando J, Prien S, Huang JC. 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 Complement Altern Med. 2017 Apr 4;17(1):197. doi: 10.1186/s12906-017-1693-4.

  PMID: 28376836 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jennifer L Phy, DO

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 29, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (1)