Acupuncture, Chinese Traditional Medicine, in Embryo Transfer
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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 |
- 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.
| 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 |
|---|---|
|
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
|
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
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 to 35 years old
- 20-25 Body mass index (BMI)
- Medical indication of intracytoplasmic sperm injection (ICSI) treatment to treat sterility
- No previous in vitro fertilization (IVF) or intracytoplasmic sperm inyection (ICSI) treatments
- No previous experience of acupuncture treatments
- Male cause of sterility
- At least one high quality embryo in the day of uterine trasnfer
Exclusion Criteria:
- Polycystic ovarian síndrome
- 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 gonadotrophin (hCG) day.
- Failure to keep confidentiality
- Concomitant illness or severe adverse reaction
Contacts and Locations| Contact: Monica Romeu, Doctor | +34-96-124-40-00 ext 244114 | romeu_monvil@gva.es |
| Contact: Jose Maria Rubio, Doctor | +34-96-124-40-00 ext 244114 | rubio_jos@gva.es |
| 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 romeu_monvil@gva.es | |
| 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 | |
| Principal Investigator: | Monica Romeu, Doctor |
More Information
Publications:
| 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: | April 18, 2012 |
| 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 May 23, 2013