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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Acupuncture on the Success Rate of IVF Treatments

Conditions
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Infertility

Intervention / Treatment
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* Procedure: acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture<br>These patients received acupuncture during the follicular development phase and on the day of egg collection. | Procedure: acupuncture<br>* patients received a Delphi acupuncture at least 3 times during their fertility treatment cycle.<br>|
| No Intervention: Control<br>Patients received standard care, no acupuncture. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | The primary objective is to determine the clinical effectiveness of acupuncture in improving live birth rates in women undergoing IVF | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | The secondary objective is to determine whether acupuncture improves clinical pregnancy rate | 18 months | 
| Multiple pregnancy | To determine whether there is an increased rate of multiple pregnancy | 9 months | 
| 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 | 9 months |