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Acupuncture, Chinese Traditional Medicine, in Embryo Transfer

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ClinicalTrials.gov Identifier: NCT01449396
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

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.

Condition or disease Intervention/treatment Phase
Pregnancy Other: Bed Rest Procedure: Acupuncture Not Applicable

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 Published studies show very different designs and inconclusive/contradictory results can be withdrawn making very difficult to take the clinical decision of recommending acupuncture or not to in vitro fertilization (IVF) patients.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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Chinese Traditional Medicine Contribution to Improve In-vitro Fertilization (IVF) Results: Acupuncture in Embryo Transfer
Actual Study Start Date : October 2011
Actual Primary Completion Date : October 2015
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: SHAM ACUPUNCTURE
Sham intervention: acupuncture needle without puncture nor stimulation
Procedure: Acupuncture
Sham acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
Experimental: REAL ACUPUNCTURE
Experimental: acupuncture in selected points of the protocol designed
Procedure: Acupuncture
Acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
Control
Bed Rest
Other: Bed Rest
Bed rest during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer



Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 14 days after embryo transfer ]
    Heart beating in intrauterus embryo


Secondary Outcome Measures :
  1. Rating preconceived ideas about acupuncture [ Time Frame: From 24 hours (h) to 14 days after embryo transfer ]
    Rating preconceived ideas about acupuncture

  2. Determination of serum prolactin and 24h urine cortisol. [ Time Frame: The day of embryo transfer (+14 days post-cycle start)). ]
    Determination of serum prolactin and 24h urine cortisol to measure stress levels on the day of embryo transfer.

  3. Endometrial vascularization study [ Time Frame: The day of embryo transfer (+14 days after cycle start) and 2 days before and after it. ]
    Endometrial vascularization study on the day of embryo transfer, 2 days before and after it

  4. Analysis of the results of assisted reproductive cycle [ Time Frame: After 14 days post-transfer (28 days after cycle star) ]
    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



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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449396


Locations
Spain
Human Reproduction Unit of the University and Politechnic Hospital La Fe.
Valencia, Spain, 46026
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Investigators
Principal Investigator: Monica Romeu, Doctor

Publications:
Dong J. Research on the reduction of anxiety and depression with acupuncture. Am J Acupunct 1993; 21: 327-30.
Paulus E, Zhang M Strehler E, Sterzik K. Motility of the endometrium after acupuncture treatment. Fertil Steril 2003; 80 (Suppl 3): 131.
Domar A, Meshay I, Kelliher J, Wang S, Alper M. The impact of acupuncture on IVF outcome. Fertil Steril 2006; 86 (Suppl 2): S378-9.
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.
Cheong YC, Hung Yu Ng E, Ledger WL. Acupuncture and assisted conception. Cochrane Database Syst Rev 2008; 4: CD006920. study. Fertil Steril 2006; 86 (Suppl2): S135.

Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT01449396     History of Changes
Other Study ID Numbers: ACU2010
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Keywords provided by Instituto de Investigacion Sanitaria La Fe:
acupuncture
in vitro fertilization
embryo transfer