Acupuncture, Chinese Traditional Medicine, in Embryo Transfer

NCT ID: NCT01449396

Last Updated: 2018-03-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2018-03-31

Brief Summary

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The aim of the study is to prove that acupuncture applied before and after embryo transfer is able to increase pregnancy rates by means of reducing stress and improving endometrial vascularization in women receiving in vitro Fertilization (IVF) treatments.

Detailed Description

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Around 75% of all in vitro fertilization (IVF) treatments fail in providing a healthy baby at home. Most of the women undergoing those techniques suffer in some extent anxiety, depression and stress. Stress make IVF results worse and it has been prove by correlating cortisol, adrenaline and noradrenaline levels with failed cycles. Acupuncture has proved its ability to reduce stress levels. Moreover, Acupuncture has prove to have an effect inhibitory on the sympathetic system and this capacity improves vascularization in uterus and ovaries. Available literature concerning these two issues is not conclusive because of studies design. Acupuncture´s biological mechanism on controlled ovarian stimulation and embryo transfer has not been completely described; if it really has one. Published studies show very different designs and inconclusive/contradictory results can be withdrawn making very difficult to take the clinical decision of recommending acupuncture or not to in vitro fertilization (IVF) patients. If acupuncture really enhance pregnancy rates in IVF cycles still unanswered given that no randomized three arms study comparing no intervention to sham acupuncture to acupuncture has been published.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SHAM ACUPUNCTURE

Sham intervention: acupuncture needle without puncture nor stimulation

Group Type SHAM_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

Acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer

Control

Bed Rest

Group Type OTHER

Bed Rest

Intervention Type OTHER

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

Intervention Type OTHER

Acupuncture

Sham acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer

Intervention Type PROCEDURE

Acupuncture

Acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 to 37 years old
* 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

* Polycystic ovarian syndrome
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Spain

References

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Dong J. Research on the reduction of anxiety and depression with acupuncture. Am J Acupunct 1993; 21: 327-30.

Reference Type 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.

Reference Type BACKGROUND
PMID: 8671446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11937123 (View on PubMed)

Paulus E, Zhang M Strehler E, Sterzik K. Motility of the endometrium after acupuncture treatment. Fertil Steril 2003; 80 (Suppl 3): 131.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 16600225 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16616748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16600232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18314118 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Magarelli P, Criddenda D. Acupuncture and IVF poor responders: a cure? Fertil Steril 2004; 81: S20.

Reference Type BACKGROUND

Magarelli ´P, Cohen M, Criddenda D. Acupuncture and good prognosis IVF patients: synergy. Fertil Steril 2004; 82: S80-1.

Reference Type BACKGROUND

Magarelli P, Cohen M, Criddenda D. Acupuncture: impact on pregnancy outcomes in IVF patients. 12th World Congress on Human Reproduction, Venice, Italy, March 2005.

Reference Type BACKGROUND

Magarelli P, Cohen M, Criddenda D. Improvement of IVF outcomes by acupuncture: are egg and embryo qualities involved? Fertil Steril 2005; 83: S9.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Magarelli P, Criddenda D, Cohen M. Proposed mechanism of action of acupuncture on IVF outcomes. Fertil Steril 2006; 86: S174-5.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 18652588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18258932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18440533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18843737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18940896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14662058 (View on PubMed)

Other Identifiers

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ACU2010

Identifier Type: -

Identifier Source: org_study_id

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