Acupuncture, Chinese Traditional Medicine, in Embryo Transfer

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Procedure: Acupuncture; Other: Bed Rest

• Registration Number: NCT01449396
• Lead Sponsor: Instituto de Investigacion Sanitaria La Fe

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 Published studies show very different designs and inconclusive/contradictory results can be withdrawn making very difficult to take the clinical decision of recommending acupuncture or not to in vitro fertilization (IVF) patients.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

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Primary Completion: 2015-10
• Status Verified: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 286

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHAM ACUPUNCTURE	Acupuncture	Sham intervention: acupuncture needle without puncture nor stimulation
Control	Bed Rest	Bed Rest
REAL ACUPUNCTURE	Acupuncture	Experimental: acupuncture in selected points of the protocol designed

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	14 days after embryo transfer	Heart beating in intrauterus embryo

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Human Reproduction Unit of the University and Politechnic Hospital La Fe.; 🇪🇸 Valencia, Spain