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
  Purpose

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.


Condition Intervention
Effect of Acupuncture on Infertile PCOS Patients.
Device: Acupuncture(Hwato®)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture Treatment Versus Non-acupuncture During IVF

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Clinical pregnancy rate. [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ongoing pregnancy rate [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: March 2011
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Acupuncture(Hwato®)
acupuncture using 4cm long disposable stainless steel hair-thin needles manufactured by Suzhou medical appliance factory (China).
No Intervention: No acupuncture
No intervention was done for this group of patients.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778621

Locations
China, Hubei
Assisted Reproduction Center, Department of Obstetrics and Gynecology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Sponsors and Collaborators
Amina Altutunji
Huazhong University of Science and Technology
Investigators
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
  More Information

No publications provided

Responsible Party: Amina Altutunji, Doctor /assissted reproduction center/Union Hospital, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01778621     History of Changes
Other Study ID Numbers: MINA-1978
Study First Received: January 23, 2013
Last Updated: January 25, 2013
Health Authority: China: Ethics Committee

Keywords provided by Huazhong University of Science and Technology:
Acupuncture
AMH
Infertility
PCOS
Pregnancy rate

Additional relevant MeSH terms:
Infertility
Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 26, 2014