Acupuncture, Chinese Traditional Medicine, 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.
|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|
- Pregnancy rate [ Time Frame: 14 days after embryo transfer ] [ Designated as safety issue: Yes ]Heart beating in intrauterus embryo
- 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.
|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)|
No Intervention: CONTROL
No intervention: rest during 25 minutes
Other: Bed Rest
Bed rest 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
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
Acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
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 nosadrenaline 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.
|Contact: Monica Romeu, Doctor||+34-96-124-40-00 ext email@example.com|
|Contact: Jose Maria Rubio, Doctor||+34-96-124-40-00 ext firstname.lastname@example.org|
|Human Reproduction Unit of the University and Politechnic Hospital La Fe.||Recruiting|
|Valencia, Spain, 46026|
|Contact: Monica Romeu, Doctor +18.104.22.168.40 ext 244114 email@example.com|
|Contact: Patri Polo, Dr. +22.214.171.124.40 ext 244114 firstname.lastname@example.org|
|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|
|Principal Investigator:||Monica Romeu, Doctor|