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

NCT ID: NCT00913354

Last Updated: 2009-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

635 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-03-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

30 minutes of acupuncture just before and just after embryo replacement

Group Type EXPERIMENTAL

Acupuncture (Carbo®)

Intervention Type 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.

2

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

Group Type PLACEBO_COMPARATOR

Placebo acupuncture (Strietberger®)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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Acupuncture needles: Carbo® needle,Acupharma A/S. Sham acupuncture needles: Strietberger® placebo-needle, Asia Med.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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The Fertility Clinic, Copenhagen University Hospital, Denmark

Principal Investigators

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Dorthe Andersen, Study nurse

Role: PRINCIPAL_INVESTIGATOR

The Fertility Clinic, Copenhagen University Hospital Rigshospitalet

Locations

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The Fertility Clinic, Copenhagen University Hospital, Denmark

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Acupuncture001

Identifier Type: -

Identifier Source: org_study_id

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