Acupuncture, Chinese Traditional Medicine, in Embryo Transfer

Instituto de Investigacion Sanitaria La Fe

Status: Completed

Conditions: Pregnancy

Treatments: Procedure: Acupuncture; Other: Bed Rest

Study type: Interventional

Funder types: Other

Identifiers

NCT01449396

ACU2010

Details and patient eligibility

About

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.

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 Published studies show very different designs and inconclusive/contradictory results can be withdrawn making very difficult to take the clinical decision of recommending acupuncture or not to in vitro fertilization (IVF) patients.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

Enrollment: 286 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

286 participants in 3 patient groups

SHAM ACUPUNCTURE

Sham Comparator group

Description:

Sham intervention: acupuncture needle without puncture nor stimulation

Treatment:

Procedure: Acupuncture

Procedure: Acupuncture

REAL ACUPUNCTURE

Experimental group

Description:

Experimental: acupuncture in selected points of the protocol designed

Treatment:

Procedure: Acupuncture

Procedure: Acupuncture

Control

Other group

Description:

Bed Rest

Treatment:

Other: Bed Rest