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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

Tracking Information
First Submitted Date  ICMJE January 11, 2016
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date February 17, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
  • Clinical pregnancy rate [ Time Frame: 18 months ]
    The secondary objective is to determine whether acupuncture improves clinical pregnancy rate
  • Multiple pregnancy [ Time Frame: 9 months ]
    To determine whether there is an increased rate of multiple pregnancy
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Acupuncture on the Success Rates of IVF (In Vitro Fertilisation) Treatments
Official Title  ICMJE The Impact of Acupuncture on the Success Rate of IVF Treatments
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE Procedure: acupuncture
patients received a Delphi acupuncture at least 3 times during their fertility treatment cycle.
Study Arms  ICMJE
  • Active Comparator: Acupuncture
    These patients received acupuncture during the follicular development phase and on the day of egg collection.
    Intervention: Procedure: acupuncture
  • No Intervention: Control
    Patients received standard care, no acupuncture.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2016)
184
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 43 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02683967
Other Study ID Numbers  ICMJE FE1303
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Homerton University Hospital NHS Foundation Trust
Study Sponsor  ICMJE Homerton University Hospital NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karin Gillerman NHS Honorary Contract
PRS Account Homerton University Hospital NHS Foundation Trust
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP