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Effect of Follicular Phase Acupuncture on Anti-Mullerian Hormone in Polycystic Ovary Syndrome (PCOS) Patients Undergoing IVF And The Effect on Assisted Reproduction Outcome

This study has been completed.
Sponsor:
Collaborator:
Huazhong University of Science and Technology
Information provided by (Responsible Party):
Amina Altutunji, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01778621
First received: January 23, 2013
Last updated: January 25, 2013
Last verified: January 2013
History of Changes

January 23, 2013
January 25, 2013
March 2011
March 2012   (final data collection date for primary outcome measure)
Clinical pregnancy rate. [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01778621 on ClinicalTrials.gov Archive Site
Ongoing pregnancy rate [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Follicular Phase Acupuncture on Anti-Mullerian Hormone in Polycystic Ovary Syndrome (PCOS) Patients Undergoing IVF And The Effect on Assisted Reproduction Outcome
Acupuncture Treatment Versus Non-acupuncture During IVF

Acupuncture at follicular phase of the cycle may improve the pregnancy rate. This study aims to compare assisted reproduction outcome between two groups of infertile PCOS patients underwent IVF, one group received acupuncture and other group without acupuncture.

Follicular phase acupuncture applied for infertile PCOS patients underwent IVF to evaluate the effect of acupuncture on anti-mullerian hormone (AMH) and the effect on assisted reproduction outcome. It applied at certain acupoints according to the principles of traditional Chinese medicine.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Effect of Acupuncture on Infertile PCOS Patients.
Device: Acupuncture(Hwato®)
acupuncture using 4cm long disposable stainless steel hair-thin needles manufactured by Suzhou medical appliance factory (China).
  • Experimental: Acupuncture (Hwato®)
    30-40 minutes acupuncture at certain acupoints that chosen according to traditional Chinese medicine and included LIV3,SP6,SP8,ST36,SP10,ST29,LI14,Ren 04;starting at follicular phase of the cycle till 2 days before oocyte picked up.
    Intervention: Device: Acupuncture(Hwato®)
  • No Intervention: No acupuncture
    No intervention was done for this group of patients.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
May 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria::

  • PCOS patients with patent one or two fallopian tubes, normal uterine cavity and partners with normal semen parameters.
  • infertility
  • 20-40 years
  • IVF treatment -

Exclusion Criteria:

  • patients with disorders that have the similar clinical presentation
  • closed both tubes
  • abnormal semen parameters
  • intracytoplasmic sperm injection (ICSI)
Female
20 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01778621
MINA-1978
No
Amina Altutunji, Huazhong University of Science and Technology
Amina Altutunji
Huazhong University of Science and Technology
Study Director: Ying Gao, Ph.D., M.D. Assisted Reproduction Center, Department of Obstetrics and Gynecology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Huazhong University of Science and Technology
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP