NCT00317317

Brief 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. It is hypothesized that acupuncture can significantly increase the IVF pregnancy rate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

September 11, 2019

Status Verified

August 1, 2009

Enrollment Period

3.3 years

First QC Date

April 20, 2006

Last Update Submit

September 10, 2019

Conditions

Keywords

IVFAcupuncturePregnant

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    6 to 8 weeks

Secondary Outcomes (4)

  • Miscarriage rate

    one year

  • Take home baby rate

    one year

  • B-endorphin levels

    2 weeks

  • Stress measurement

    4 weeks

Interventions

AcupuncturePROCEDURE

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

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Reproductive Endocrinology and Infertility, Dept. of OB/GYN

Baltimore, Maryland, 21201, United States

Location

The GBMC Fertility Center

Baltimore, Maryland, 21204, United States

Location

Related Publications (1)

  • 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.

    PMID: 11937123BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Grant Zhang, Ph.D.

    Center For Integrative Medicine, University of Maryland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 20, 2006

First Posted

April 24, 2006

Study Start

October 1, 2005

Primary Completion

February 1, 2009

Study Completion

November 1, 2009

Last Updated

September 11, 2019

Record last verified: 2009-08

Locations