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

Infertility Clinical Trial

Official title:

The Impact of Acupuncture on the Success Rate of IVF Treatments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683967
• Other study ID #: FE1303
• Status: Completed
• Phase: N/A
• First received: January 11, 2016
• Last updated: February 12, 2016
• Start date: November 2013
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Homerton University Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• acupuncture
patients received a Delphi acupuncture at least 3 times during their fertility treatment cycle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Homerton University Hospital NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical pregnancy rate	The secondary objective is to determine whether acupuncture improves clinical pregnancy rate	18 months	No
Secondary	Multiple pregnancy	To determine whether there is an increased rate of multiple pregnancy	9 months	No
Secondary	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	No