Acupuncture Versus Placebo Acupuncture During In Vitro Fertilization (IVF) Embryo Transfer

Infertility Clinical Trial

Official title:

Acupuncture Versus Placebo Acupuncture During Ivf Embryo Transfer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913354
• Other study ID #: Acupuncture001
• Status: Completed
• Phase: N/A
• First received: June 3, 2009
• Last updated: June 3, 2009
• Start date: November 2005
• Est. completion date: March 2009

Study information

• Verified date: November 2005
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

During IVF treatment, acupuncture at the time of embryo transfer may improve the pregnancy rate. This study aims to compare IVF pregnancy between two groups of patients that received either acupuncture or sham acupuncture (placebo)around embryo transfer

Description:

Acupuncture at the time of embryo transfer may improve the IVF pregnancy rate. This study aims to compare the IVF pregnancy between two groups of patients that undergo ivf/icsi treatment. The patients are randomized to receive either acupuncture or sham acupuncture (placebo)around embryo transfer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 635
• Est. completion date: March 2009
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

Inclusion Criteria:

• infertility

• below 38 years

• ivf or icsi treatment

• fresh embryo transfer cycle

• no more than two earlier embryo transfers with "fresh" embryos

• embryo transfer on day 2 or 3 after oocyte aspiration, single or double embryo transfer

Exclusion Criteria:

• Frozen embryo transfer

• oocyte donation

• other "alternative" treatment during the cycle

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Acupuncture (Carbo®)
The acupuncture points were chosen according to traditional Chinese medicine and included DU20, M29, KS6, Mp8, and Le3 before embryo transfer and DU20, Co4, Mp10, M36, and Mp6 after embryo transfer.
• Placebo acupuncture (Strietberger®)
The acupuncture points were the same as in the true acupuncture group, namely DU20, M29, KS6, Mp8, and Le3 before embryo transfer and DU20, Co4, Mp10, M36, and Mp6 after embryo transfer. Sham acupuncture needles used were the validated Strietberger® placebo-needle from the company, Asia Med. The needle is not fixed inside the copper handle and its tip is blunt. When the needle touches the skin it moves inside the handle and appears to be shortened. A pricking sensation is felt by the patient, simulating the puncturing of the skin. Developed by dr. Konrad Streitberger.

Locations

Country	Name	City	State
Denmark	The Fertility Clinic, Copenhagen University Hospital, Denmark	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate		2005-2008	No