Acupuncture, Chinese Traditional Medicine, in Embryo Transfer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Instituto de Investigacion Sanitaria La Fe
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier:
NCT01449396
First received: October 4, 2011
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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 Intervention
Pregnancy by In Vitro Fertilization
Other: Bed Rest
Procedure: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Chinese Traditional Medicine Contribution to Improve In-vitro Fertilization (IVF) Results: Acupuncture in Embryo Transfer

Resource links provided by NLM:


Further study details as provided by Instituto de Investigacion Sanitaria La Fe:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: 14 days after embryo transfer ] [ Designated as safety issue: Yes ]
    Heart beating in intrauterus embryo


Secondary Outcome Measures:
  • Rating preconceived ideas about acupuncture [ Time Frame: From 24 hours (h) to 14 days after embryo transfer ] [ Designated as safety issue: Yes ]
    Rating preconceived ideas about acupuncture

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

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

  • Analysis of the results of assisted reproductive cycle [ Time Frame: After 14 days post-transfer (28 days after cycle star) ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 252
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 37 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449396

Contacts
Contact: Monica Romeu, Doctor +34-96-124-40-00 ext 244114 monicaromeu@hotmail.com
Contact: Jose Maria Rubio, Doctor +34-96-124-40-00 ext 244114 rubio_jos@gva.es

Locations
Spain
Human Reproduction Unit of the University and Politechnic Hospital La Fe. Recruiting
Valencia, Spain, 46026
Contact: Monica Romeu, Doctor    +34.96.124.40.40 ext 244114    monicaromeu@hotmail.com   
Contact: Patri Polo, Dr.    +34.96.124.40.40 ext 244114    ppolos@hotmail.com   
Principal Investigator: Monica Romeu, Doctor         
Sub-Investigator: Patri Polo, Doctor         
Sub-Investigator: Alfredo Perales, Resident         
Sub-Investigator: Germán Herrero, Doctor         
Sub-Investigator: Jose Maria Rubio, Doctor         
Sub-Investigator: Irene Peinado, Doctor         
Sub-Investigator: Mª Jose Vidal, Traditional Chinese Medicine         
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Investigators
Principal Investigator: Monica Romeu, Doctor
  More Information

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

Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT01449396     History of Changes
Other Study ID Numbers: ACU2010
Study First Received: October 4, 2011
Last Updated: October 16, 2013
Health Authority: Ethics Committee of Hospital Universitari i Politècnic La Fe: "Spain"

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

ClinicalTrials.gov processed this record on July 23, 2014