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

Primary Purpose

Infertility

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Acupuncture (Carbo®)

Placebo acupuncture (Strietberger®)

About this trial

This is an interventional treatment trial for Infertility focused on measuring infertility, ivf, acupuncture

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

The Fertility Clinic, Copenhagen University Hospital, Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

30 minutes of acupuncture just before and just after embryo replacement

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

Outcomes

Primary Outcome Measures

Clinical pregnancy rate

Secondary Outcome Measures

Full Information

NCT ID

NCT00913354

First Posted

June 3, 2009

Last Updated

June 3, 2009

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT00913354

Brief Title

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

Official Title

Acupuncture Versus Placebo Acupuncture During Ivf Embryo Transfer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2005

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

5. Study Description

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

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

infertility, ivf, acupuncture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

635 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

30 minutes of acupuncture just before and just after embryo replacement

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Acupuncture (Carbo®)

Other Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

Placebo acupuncture (Strietberger®)

Other Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Clinical pregnancy rate

Time Frame

2005-2008

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

37 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dorthe Andersen, Study nurse

Organizational Affiliation

The Fertility Clinic, Copenhagen University Hospital Rigshospitalet

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Fertility Clinic, Copenhagen University Hospital, Denmark

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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