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The Impact of Acupuncture on the Success Rates of IVF (In Vitro Fertilisation) Treatments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683967
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Homerton University Hospital NHS Foundation Trust

Study Description
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Brief Summary:
The trial aims to investigate whether acupuncture has an effect in increasing clinical pregnancy (pregnancy that is confirmed by a scan) and live birth rates on women undergoing IVF treatment.

Condition or disease Intervention/treatment Phase
Infertility Procedure: acupuncture Not Applicable

Detailed Description:

Failing to conceive naturally poses significant stress to the infertile couple. It creates a feeling of failure and frustration. It has been found that the use of complementary therapies makes women feel empowered, with a sense of regaining control of the body.

The popularity of acupuncture is increasing. A significant proportion of couples having fertility treatment, especially IVF (In-Vitro Fertilisation) ask their clinician about using acupuncture and some patients undergo acupuncture privately without reporting to their clinicians.

The effectiveness of acupuncture on IVF has been extensively researched; however the results are varied and not conclusive. This is due to previous studies varying significantly in their study design, acupuncture timing and the final outcome measure. As a result of the difference in the studies it is not clear whether acupuncture is beneficial regarding IVF success rates and whether it should be offered to women undergoing IVF.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Acupuncture on the Success Rate of IVF Treatments
Study Start Date : November 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Acupuncture
These patients received acupuncture during the follicular development phase and on the day of egg collection.
 Procedure: acupuncture
patients received a Delphi acupuncture at least 3 times during their fertility treatment cycle.
No Intervention: Control
Patients received standard care, no acupuncture.


Outcome Measures
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Primary Outcome Measures :
  1. Live birth rate [ Time Frame: 18 months ]
    The primary objective is to determine the clinical effectiveness of acupuncture in improving live birth rates in women undergoing IVF


Secondary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 18 months ]
    The secondary objective is to determine whether acupuncture improves clinical pregnancy rate

  2. Multiple pregnancy [ Time Frame: 9 months ]
    To determine whether there is an increased rate of multiple pregnancy

  3. Quality of life [ Time Frame: 9 months ]
    To examine the effect of acupuncture on improving the quality of life for women by means of EQ% quality of life questionnaires


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women under the age of 43 years with a BMI of less than 30 undergoing 1st or no more than their 2nd failed fresh IVF or ICSI cycle.

Exclusion Criteria:

  • Those women undergoing frozen embryo replacement cycle or receiving donor eggs, BMI > 30 or currently having acupuncture/ any other form of CAM, having contraindication to acupuncture like those with HIV, Hep C will be excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683967


Sponsors and Collaborators
Homerton University Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Karin Gillerman NHS Honorary Contract
More Information
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Responsible Party: Homerton University Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02683967    
Other Study ID Numbers: FE1303
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female