NCT01449396

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

4 years

First QC Date

October 4, 2011

Last Update Submit

March 6, 2018

Conditions

Pregnancy

Keywords

acupuncturein vitro fertilizationembryo transfer

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    Heart beating in intrauterus embryo

    14 days after embryo transfer

Secondary Outcomes (4)

  • Rating preconceived ideas about acupuncture

    From 24 hours (h) to 14 days after embryo transfer

  • Determination of serum prolactin and 24h urine cortisol.

    The day of embryo transfer (+14 days post-cycle start)).

  • Endometrial vascularization study

    The day of embryo transfer (+14 days after cycle start) and 2 days before and after it.

  • Analysis of the results of assisted reproductive cycle

    After 14 days post-transfer (28 days after cycle star)

Study Arms (3)

SHAM ACUPUNCTURE

SHAM COMPARATOR

Sham intervention: acupuncture needle without puncture nor stimulation

Procedure: Acupuncture

REAL ACUPUNCTURE

EXPERIMENTAL

Experimental: acupuncture in selected points of the protocol designed

Procedure: Acupuncture

Control

OTHER

Bed Rest

Other: Bed Rest

Interventions

Bed RestOTHER

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

Control
AcupuncturePROCEDURE

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

SHAM ACUPUNCTURE

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 37 years old
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Reproduction Unit of the University and Politechnic Hospital La Fe.

Valencia, 46026, Spain

Location

Related Publications (23)

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

    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: 8671446BACKGROUND

  • 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.

    PMID: 11937123BACKGROUND

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

    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.

    PMID: 16600225BACKGROUND

  • 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.

    PMID: 16616748BACKGROUND

  • 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.

    PMID: 16600232BACKGROUND

  • 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.

    PMID: 18314118BACKGROUND

  • 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

    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.

    BACKGROUND

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

    BACKGROUND

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

    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.

    BACKGROUND

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

    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.

    BACKGROUND

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

    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.

    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.

    PMID: 18652588BACKGROUND

  • 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: 18258932BACKGROUND

  • 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: 18440533BACKGROUND

  • 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.

    PMID: 18843737BACKGROUND

  • 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.

    PMID: 18940896BACKGROUND

  • 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.

    PMID: 14662058BACKGROUND

MeSH Terms

Interventions

Bed RestAcupuncture Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsComplementary Therapies

Study Officials

  • Monica Romeu, Doctor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2011

First Posted

October 10, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2015

Study Completion

March 1, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

ES(1)