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: August 4, 2014
Last verified: October 2013

October 4, 2011
August 4, 2014
October 2011
October 2014   (final data collection date for primary outcome measure)
Pregnancy rate [ Time Frame: 14 days after embryo transfer ] [ Designated as safety issue: Yes ]
Heart beating in intrauterus embryo
Same as current
Complete list of historical versions of study NCT01449396 on ClinicalTrials.gov Archive Site
  • 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
  • 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 vascularition 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.
Not Provided
Not Provided
 
Acupuncture, Chinese Traditional Medicine, in Embryo Transfer
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pregnancy
  • Other: Bed Rest
    Bed rest during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
  • Procedure: Acupuncture
    Sham acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
  • Procedure: Acupuncture
    Acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
  • Sham Comparator: SHAM ACUPUNCTURE
    Sham intervention: acupuncture needle without puncture nor stimulation
    Intervention: Procedure: Acupuncture
  • Experimental: REAL ACUPUNCTURE
    Experimental: acupuncture in selected points of the protocol designed
    Intervention: Procedure: Acupuncture
  • Control
    Bed Rest
    Intervention: Other: Bed Rest

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
252
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 37 Years
No
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
Spain
 
NCT01449396
ACU2010
Yes
Instituto de Investigacion Sanitaria La Fe
Instituto de Investigacion Sanitaria La Fe
Not Provided
Principal Investigator: Monica Romeu, Doctor
Instituto de Investigacion Sanitaria La Fe
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP