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

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Homerton University Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Acupuncture

    Control

    Arm Description

    These patients received acupuncture during the follicular development phase and on the day of egg collection.

    Patients received standard care, no acupuncture.

    Outcomes

    Primary Outcome Measures

    Live birth rate
    The primary objective is to determine the clinical effectiveness of acupuncture in improving live birth rates in women undergoing IVF

    Secondary Outcome Measures

    Clinical pregnancy rate
    The secondary objective is to determine whether acupuncture improves clinical pregnancy rate
    Multiple pregnancy
    To determine whether there is an increased rate of multiple pregnancy
    Quality of life
    To examine the effect of acupuncture on improving the quality of life for women by means of EQ% quality of life questionnaires

    Full Information

    First Posted
    January 11, 2016
    Last Updated
    February 12, 2016
    Sponsor
    Homerton University Hospital NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02683967
    Brief Title
    The Impact of Acupuncture on the Success Rates of IVF (In Vitro Fertilisation) Treatments
    Official Title
    The Impact of Acupuncture on the Success Rate of IVF Treatments
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2013 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Homerton University Hospital NHS Foundation Trust

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    184 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture
    Arm Type
    Active Comparator
    Arm Description
    These patients received acupuncture during the follicular development phase and on the day of egg collection.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients received standard care, no acupuncture.
    Intervention Type
    Procedure
    Intervention Name(s)
    acupuncture
    Intervention Description
    patients received a Delphi acupuncture at least 3 times during their fertility treatment cycle.
    Primary Outcome Measure Information:
    Title
    Live birth rate
    Description
    The primary objective is to determine the clinical effectiveness of acupuncture in improving live birth rates in women undergoing IVF
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Clinical pregnancy rate
    Description
    The secondary objective is to determine whether acupuncture improves clinical pregnancy rate
    Time Frame
    18 months
    Title
    Multiple pregnancy
    Description
    To determine whether there is an increased rate of multiple pregnancy
    Time Frame
    9 months
    Title
    Quality of life
    Description
    To examine the effect of acupuncture on improving the quality of life for women by means of EQ% quality of life questionnaires
    Time Frame
    9 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    43 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karin Gillerman
    Organizational Affiliation
    NHS Honorary Contract
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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