InfertilityNCT02683967
The Impact of Acupuncture on the Success Rates of IVF (In Vitro Fertilisation) Treatments
A study testing acupuncture in people with Infertility, run by Homerton University Hospital NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: The Impact of Acupuncture on the Success Rate of IVF Treatments
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- acupuncture
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
patients received a Delphi acupuncture at least 3 times during their fertility treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Active comparator | These patients received acupuncture during the follicular development phase and on the day of egg collection. Receives: Procedure: acupuncture |
| Control | No intervention | Patients received standard care, no acupuncture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
The primary objective is to determine the clinical effectiveness of acupuncture in improving live birth rates in women undergoing IVF
Measured: 18 months
Secondary outcomes (3)
Clinical pregnancy rate
The secondary objective is to determine whether acupuncture improves clinical pregnancy rate
Measured: 18 months
Multiple pregnancy
To determine whether there is an increased rate of multiple pregnancy
Measured: 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startNov 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Homerton University Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin Gillerman, Principal investigator, NHS Honorary Contract
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683967
- Sponsor's protocol ID
- FE1303
- Status last verified
- Feb 2016
- First submitted
- 11 Jan 2016
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Acupuncture on the Success Rate of IVF Treatments
- ClinicalTrials.gov ID
- NCT02683967
- Acronym / sponsor ID
- FE1303
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Homerton University Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Active comparator | Procedure: acupunctureThese patients received acupuncture during the follicular development phase and on the day of egg collection. |
| Control | No intervention | –Patients received standard care, no acupuncture. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncturepatients received a Delphi acupuncture at least 3 times during their fertility treatment cycle. | Procedure or surgery | Acupuncture |
Primary outcome
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
3 secondary outcomes
Clinical pregnancy rate
Time frame: 18 months
Multiple pregnancy
Time frame: 9 months
Quality of life
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Gillerman principal investigator
NHS Honorary Contract
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Infertility, run by Homerton University Hospital NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.