Acupuncture, Chinese Traditional Medicine, in Embryo Transfer

Study Overview
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Brief Summary
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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.

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 Published studies show very different designs and inconclusive/contradictory results can be withdrawn making very difficult to take the clinical decision of recommending acupuncture or not to in vitro fertilization (IVF) patients.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

Official Title
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Chinese Traditional Medicine Contribution to Improve In-vitro Fertilization (IVF) Results: Acupuncture in Embryo Transfer

Conditions
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Pregnancy

Intervention / Treatment
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* Other: Bed Rest
* Procedure: Acupuncture
* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Heart beating in intrauterus embryo | 14 days after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating preconceived ideas about acupuncture | Rating preconceived ideas about acupuncture | From 24 hours (h) to 14 days after embryo transfer | 
| Determination of serum prolactin and 24h urine cortisol. | Determination of serum prolactin and 24h urine cortisol to measure stress levels on the day of embryo transfer. | The day of embryo transfer (+14 days post-cycle start)). | 
| Endometrial vascularization study | Endometrial vascularization study on the day of embryo transfer, 2 days before and after it | The day of embryo transfer (+14 days after cycle start) and 2 days before and after it. | 
| Analysis of the results of assisted reproductive cycle | 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 | After 14 days post-transfer (28 days after cycle star) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, in vitro fertilization, embryo transfer