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

NCT00913354 | Completed

• 1 other identifier: Acupuncture001
• Study Type: interventional
• Target: 635
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Infertility

Keywords

infertility; ivf; acupuncture

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  2005-2008

Study Arms (2)

1

EXPERIMENTAL

30 minutes of acupuncture just before and just after embryo replacement

Device: Acupuncture (Carbo®)

2

PLACEBO COMPARATOR

Sham acupuncture for 30 minutes just before and just after embryo transfer

Device: Placebo acupuncture (Strietberger®)

Interventions

Acupuncture (Carbo®) DEVICE

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.

Also known as: Acupuncture needles: Carbo® needle,Acupharma A/S.

1

Placebo acupuncture (Strietberger®) DEVICE

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.

Also known as: Sham acupuncture needles: Strietberger® placebo-needle, Asia Med.

2

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Frozen embryo transfer
• oocyte donation
• other "alternative" treatment during the cycle

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

The Fertility Clinic, Copenhagen University Hospital, Denmark

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Infertility; Long Qt Syndrome 3

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Dorthe Andersen, Study nurse

  The Fertility Clinic, Copenhagen University Hospital Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 4, 2009
• Study Start: November 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2009
• Last Updated: June 4, 2009

Record last verified: 2005-11

Locations

DK (1)