Acupuncture, Chinese Traditional Medicine, in Embryo Transfer
NCT ID: NCT01449396
Last Updated: 2018-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
286 participants
INTERVENTIONAL
2011-10-31
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SHAM ACUPUNCTURE
Sham intervention: acupuncture needle without puncture nor stimulation
Acupuncture
Sham acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
REAL ACUPUNCTURE
Experimental: acupuncture in selected points of the protocol designed
Acupuncture
Acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
Control
Bed Rest
Bed Rest
Bed rest during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
Interventions
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Bed Rest
Bed rest during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
Acupuncture
Sham acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
Acupuncture
Acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
Eligibility Criteria
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Inclusion Criteria
* 18-28 Body mass index (BMI)
* Medical indication of intracytoplasmic sperm injection (ICSI) treatment to treat sterility
* No previous in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatments
* No previous experience of acupuncture treatments
* At least one high quality embryo in the day of uterine transfer
Exclusion Criteria
* Endometriosis
* Reproductive surgeries: any on uterus, fallopian tubes or ovaries
* Ovarian cysts \>20mm at the beginning of the stimulation cycle
* Hormone treatment in the previous three months of the stimulation cycle, including oral contraceptives
* Previous miscarriages and ectopic pregnancies
* Coasting
* Oestradiol levels \>3500pg/ml or ovarian size \>65mm in human chorio gonadotropin (hCG) day.
* Failure to keep confidentiality
* Concomitant illness or severe adverse reaction
18 Years
37 Years
FEMALE
No
Sponsors
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Instituto de Investigacion Sanitaria La Fe
OTHER
Responsible Party
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Principal Investigators
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Monica Romeu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Locations
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Human Reproduction Unit of the University and Politechnic Hospital La Fe.
Valencia, , Spain
Countries
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References
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Dong J. Research on the reduction of anxiety and depression with acupuncture. Am J Acupunct 1993; 21: 327-30.
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.
Paulus WE, Zhang M, Strehler E, El-Danasouri I, Sterzik K. Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy. Fertil Steril. 2002 Apr;77(4):721-4. doi: 10.1016/s0015-0282(01)03273-3.
Paulus E, Zhang M Strehler E, Sterzik K. Motility of the endometrium after acupuncture treatment. Fertil Steril 2003; 80 (Suppl 3): 131.
Smith C, Coyle M, Norman RJ. Influence of acupuncture stimulation on pregnancy rates for women undergoing embryo transfer. Fertil Steril. 2006 May;85(5):1352-8. doi: 10.1016/j.fertnstert.2005.12.015. Epub 2006 Apr 5.
Dieterle S, Ying G, Hatzmann W, Neuer A. Effect of acupuncture on the outcome of in vitro fertilization and intracytoplasmic sperm injection: a randomized, prospective, controlled clinical study. Fertil Steril. 2006 May;85(5):1347-51. doi: 10.1016/j.fertnstert.2005.09.062. Epub 2006 Apr 17.
Westergaard LG, Mao Q, Krogslund M, Sandrini S, Lenz S, Grinsted J. Acupuncture on the day of embryo transfer significantly improves the reproductive outcome in infertile women: a prospective, randomized trial. Fertil Steril. 2006 May;85(5):1341-6. doi: 10.1016/j.fertnstert.2005.08.070. Epub 2006 Apr 5.
Domar AD, Meshay I, Kelliher J, Alper M, Powers RD. The impact of acupuncture on in vitro fertilization outcome. Fertil Steril. 2009 Mar;91(3):723-6. doi: 10.1016/j.fertnstert.2008.01.018. Epub 2008 Mar 7.
Benson M, ElKind-Hirsch K, Theall A, Fong K, Hogan R, Scott R. Impact of the acupuncture before and after embryo transfer on the outcome of in vitro fertilization cycles: a prospective single blind randomised
Craig L, Criniti A, Hansen K, Marshall L, Soules M. Acupuncture lowers pregnancy rates when performed before and after embryo transfer. Fertil Steril 2007; 88 (Suppl 1): S40.
Magarelli P, Criddenda D. Acupuncture and IVF poor responders: a cure? Fertil Steril 2004; 81: S20.
Magarelli ´P, Cohen M, Criddenda D. Acupuncture and good prognosis IVF patients: synergy. Fertil Steril 2004; 82: S80-1.
Magarelli P, Cohen M, Criddenda D. Acupuncture: impact on pregnancy outcomes in IVF patients. 12th World Congress on Human Reproduction, Venice, Italy, March 2005.
Magarelli P, Cohen M, Criddenda D. Improvement of IVF outcomes by acupuncture: are egg and embryo qualities involved? Fertil Steril 2005; 83: S9.
15.- Criddenda D, Magarelli P, Cohen M. Acupuncture and in vitro fertilization: does the number of treatments impact reproductive outcomes? Society for Acupuncture Research 2005.
Magarelli P, Criddenda D, Cohen M. Proposed mechanism of action of acupuncture on IVF outcomes. Fertil Steril 2006; 86: S174-5.
Magarelli P, Criddenda D, Cohen M. The demographics of acupuncture´s impact on IVF outcomes: infertility diagnosis and SART/CDC/age groups. Fdertil Steril 2007; 87: S10-1.
El-Toukhy T, Sunkara SK, Khairy M, Dyer R, Khalaf Y, Coomarasamy A. A systematic review and meta-analysis of acupuncture in in vitro fertilisation. BJOG. 2008 Sep;115(10):1203-13. doi: 10.1111/j.1471-0528.2008.01838.x. Epub 2008 Jul 23.
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.
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.
Cheong YC, Hung Yu Ng E, Ledger WL. Acupuncture and assisted conception. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006920. doi: 10.1002/14651858.CD006920.pub2.
So EW, Ng EH, Wong YY, Lau EY, Yeung WS, Ho PC. A randomized double blind comparison of real and placebo acupuncture in IVF treatment. Hum Reprod. 2009 Feb;24(2):341-8. doi: 10.1093/humrep/den380. Epub 2008 Oct 21.
White AR. A review of controlled trials of acupuncture for women's reproductive health care. J Fam Plann Reprod Health Care. 2003 Oct;29(4):233-6. doi: 10.1783/147118903101197863.
Other Identifiers
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ACU2010
Identifier Type: -
Identifier Source: org_study_id
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