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:
Amina Altutunji
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
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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
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 May 21, 2013