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
About this trial
This is an interventional treatment trial for Infertility
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.
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
NCT ID
NCT02683967
First Posted
January 11, 2016
Last Updated
February 12, 2016
Sponsor
Homerton University Hospital NHS Foundation Trust
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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