AzTrials
AzTrials

PregnancyNCT01449396

Acupuncture, Chinese Traditional Medicine, in Embryo Transfer

A study testing Bed Rest and Acupuncture in people with Pregnancy, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 37 years, women only
Conditions the study is for
Pregnancy
What is being tested?
Bed Rest and Acupuncture
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
286 participants
Where
1 siteSpain
Study dates
Oct 2011to Mar 2018
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 18 to 37 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

    Valencia, 46026

Other trials in Spain

About this study

Official title: Chinese Traditional Medicine Contribution to Improve In-vitro Fertilization (IVF) Results: Acupuncture in Embryo Transfer

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.

Read the detailed description

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
Pregnancy
Being tested
Bed Rest, Acupuncture
Keywords
acupuncture, in vitro fertilization, embryo transfer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bed RestOther

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

  • AcupunctureProcedure or surgery

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

  • AcupunctureProcedure or surgery

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

Study groups in NCT01449396
Study groupRoleWhat they receive
SHAM ACUPUNCTURESham comparatorSham intervention: acupuncture needle without puncture nor stimulation
Receives: Procedure: Acupuncture
REAL ACUPUNCTUREExperimentalExperimental: acupuncture in selected points of the protocol designed
Receives: Procedure: Acupuncture
ControlOtherBed Rest
Receives: Other: Bed Rest

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pregnancy rate

    Heart beating in intrauterus embryo

    Measured: 14 days after embryo transfer

Secondary outcomes (4)

  1. Rating preconceived ideas about acupuncture

    Rating preconceived ideas about acupuncture

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

  2. Determination of serum prolactin and 24h urine cortisol.

    Determination of serum prolactin and 24h urine cortisol to measure stress levels on the day of embryo transfer.

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

  3. Endometrial vascularization study

    Endometrial vascularization study on the day of embryo transfer, 2 days before and after it

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

  4. Analysis of the results of assisted reproductive cycle

    Analysis of the results of assisted reproductive cycle on levels of beta human chorionic gonadotropin (BhCG) +14 days post-transfer, evidence of intrauterine gestational sac with heartbeat and embryo live birth at home

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionOct 2015
  4. Study completionMar 2018

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
286 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01449396
Sponsor's protocol ID
ACU2010
Status last verified
Mar 2018
First submitted
4 Oct 2011
Last updated
7 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 8671446

  • 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.

    PubMed 11937123

  • 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.

    PubMed 16600225

  • 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.

    PubMed 16616748

  • 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.

    PubMed 16600232

  • 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.

    PubMed 18314118

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Bed Rest and Acupuncture in people with Pregnancy, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.

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 6 inclusion and 10 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 7 Mar 2018. 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 Spain. 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. Some participants in this study may receive a placebo. 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?

Pregnancy rate (time frame: 14 days after embryo transfer). 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 NCT01449396, which also lists 23 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 7 Mar 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in