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AzTrials

InfertilityPhase 1NCT00317317

The Effect of Acupuncture on Infertility With In-Vitro Fertilization (IVF) Patients

A Phase 1 study testing Acupuncture in people with Infertility, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Infertility is a common problem with increased incidence. In-vitro fertilization (IVF) is by far the most commonly used treatment. The success rate of IVF is still low. This study examines the effect of acupuncture on IVF pregnancy rate, as well as possible mechanisms. Read more about this study

Who is it for?
Ages 21 years and older, women only
Conditions the study is for
Infertility
What is being tested?
Acupuncture
Type of treatment
Surgery or procedure
How many people
60 participants
Where
2 sitesUnited States
Study dates
Oct 2005to Nov 2009
Phase
Phase 1
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 21 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is undergoing in-vitro fertilization protocol (both IVF and intracytoplasmic sperm injection - ICSI)
  • Patient is acupuncture naïve.
  • Patient has basal serum follicle-stimulating hormone (FSH) < 10
  • Patient has given informed consent to participate in study

Who cannot join

  • Patient has had acupuncture performed previously or currently
  • Patient has basal serum FSH of 10 or more

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Reproductive Endocrinology and Infertility, Dept. of OB/GYN

    Baltimore, Maryland, 21201

  • The GBMC Fertility Center

    Baltimore, Maryland, 21204

Other trials in United States

About this study

Official title: Acupuncture for Infertility Patients: The Effect on IVF

Infertility is a common problem with increased incidence. In-vitro fertilization (IVF) is by far the most commonly used treatment. The success rate of IVF is still low. This study examines the effect of acupuncture on IVF pregnancy rate, as well as possible mechanisms. It is hypothesized that acupuncture can significantly increase the IVF pregnancy rate.

Read the detailed description

Infertility is a common health problem in the United States with approximately 15% of women of childbearing age receiving care for this disorder. One of the most successful and commonly utilized treatment options is in-vitro fertilization (IVF). Data collected by the Center for Disease Control (CDC) and the Society for Assisted Reproduction (SART) showed that in the year 2001, over 100,000 IVF treatment cycles were performed through the more than 400 IVF centers in the U.S. Despite many recent technological advances, pregnancy rates with IVF remain limited with the most recent CDC/SART data reporting that only 27% of treatment cycles result in a live birth. Acupuncture has been utilized in China for centuries to regulate the female reproductive system and has in recent years become a popular option for infertile couples in the States. Though acupuncture has been studied in other infertility settings, IVF is chosen because:

  1. IVF is one of the most common infertility treatments as well as the most resource intensive treatment option. Therefore, an improvement in IVF success will provide the greatest benefit to patients and society.
  2. IVF affords a unique opportunity to gather the most data regarding the reproductive process and to investigate putative acupuncture related physiological changes.

We propose a randomized, sham controlled feasibility study on the effect of acupuncture on IVF. Sixty IVF patients will be recruited into the study to accomplish the following aims:

  1. To examine the feasibility of recruiting and retaining a sufficient number of patients for an adequate powered study,
  2. To identify issues related to the multicenter approach that could alter study endpoints,
  3. To examine the effect size of the treatment group as compared to the sham group,
  4. To examine whether acupuncture is a safe procedure for women undergoing IVF,
  5. To examine the effect of acupuncture on clinical IVF outcomes, and
  6. To examine the physiological and psychological impact of acupuncture on IVF patients.

Results obtained from the study will provide necessary information for a larger, definitive study, as well as knowledge regarding the broad mechanism of acupuncture on female reproductive function.

Conditions
Infertility
Being tested
Acupuncture
Keywords
IVF, Acupuncture, Pregnant
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

    4 acupuncture treatments will be conducted during the IVF cycle. The 1st one is at the beginning of egg stimulation, the 2nd one is before the egg retrieval, the 3rd and 4th one are before and after the embryo transfer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical pregnancy rate

    Measured: 6 to 8 weeks

Secondary outcomes (4)

  1. Miscarriage rate

    Measured: one year

  2. Take home baby rate

    Measured: one year

  3. B-endorphin levels

    Measured: 2 weeks

  4. Stress measurement

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2006 (estimated)
  2. Study startOct 2005
  3. Primary completionFeb 2009
  4. Study completionNov 2009

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00317317
Sponsor's protocol ID
R21AT002651-01A1
Status last verified
Aug 2009
First submitted
20 Apr 2006
Last updated
11 Sep 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Paulus WE, Zhang M, Strehler E, El-Danasouri I, Sterzik K. Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy. Fertil Steril. 2002 Apr;77(4):721-4. doi: 10.1016/s0015-0282(01)03273-3.

    PubMed 11937123

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Acupuncture in people with Infertility, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites in United States.

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 4 inclusion and 2 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 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Clinical pregnancy rate (time frame: 6 to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00317317, which also lists 1 linked publication.

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 11 Sep 2019.

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