Clinical trial NCT01449396: Acupuncture, Chinese Traditional Medicine, in Embryo Transfer
Official title: Chinese Traditional Medicine Contribution to Improve In-vitro Fertilization (IVF) Results: Acupuncture in Embryo Transfer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: acupuncture
in vitro fertilization
embryo transfer
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 286
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Published studies show very different designs and inconclusive/contradictory results can be withdrawn making very difficult to take the clinical decision of recommending acupuncture or not to in vitro fertilization (IVF) patients.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

Primary outcomes:
measure: Pregnancy rate
timeFrame: 14 days after embryo transfer
Secondary outcomes:
measure: Rating preconceived ideas about acupuncture
timeFrame: From 24 hours (h) to 14 days after embryo transfer
measure: Determination of serum prolactin and 24h urine cortisol.
timeFrame: The day of embryo transfer (+14 days post-cycle start)).
measure: Endometrial vascularization study
timeFrame: The day of embryo transfer (+14 days after cycle start) and 2 days before and after it.
measure: Analysis of the results of assisted reproductive cycle
timeFrame: After 14 days post-transfer (28 days after cycle star)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Human Reproduction Unit of the University and Politechnic Hospital La Fe.
Study officials:
name: Monica Romeu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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